| Primary | Percent Duration Without Large Deviation of End-Tidal Anesthetic Agent (EtAA) Based on Extraction Algorithm (ALG) | Percent duration of EtAA concentration during steady state maintained within the acceptable limit, which is defined as the greater of 5% of the steady state inhaled anesthetic agent concentration and 0.6% v/v for Desflurane (Des), 0.2% v/v for Sevoflurane (Sev), or 0.1% v/v for Isoflurane (Iso). The percent duration is the weighted average of all steady states for a subject, using the duration of steady state as the weight. Steady state concentration is based on an extraction algorithm described in Appendix 2 of the protocol. | Intent-to-treat population includes all randomized subjects | Posted | | Mean | Standard Deviation | percent duration | | Duration of each steady state, an average of approximately 60 minutes | | | | ID | Title | Description |
|---|
| OG000 | Et Control | Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations. | | OG001 | Control Arm | Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the conventional option, the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Conventional Fresh Gas: Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an "end case" is confirmed on the Aisys CS2 at the end of the anesthesia case. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
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| - OG00091.7± 10.82
- OG00180.8± 17.93
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Using t-test, comparison of the weighted average percent duration between the Et Control and control device was performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for both EtAA. | t-test, 2 sided | | <.001 | | Mean Difference (Net) | 10.9 | | | 2-Sided | 95 | 6.89 | 15.01 | | | | | Non-Inferiority | Using t-test, comparison of the weighted average percent duration between the Et Control and control device was performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for both EtAA. |
|
| Primary | Percent Duration Without Large Deviation of EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | Percent duration of EtAA concentration during steady state maintained within the acceptable limit, which is defined as the greater of 5% of the steady state inhaled anesthetic agent concentration and 0.6% v/v for Desflurane (Des), 0.2% v/v for Sevoflurane (Sev), or 0.1% v/v for Isoflurane (Iso). The percent duration is the weighted average of all steady states for a subject, using the duration of steady state as the weight. Data obtained using the clinicians' or Investigators' recorded target (TGT) values of anesthetic agent and oxygen for the Control Arm and using the set target values for the Et Control Arm. | Intent-to-treat population includes all randomized subjects | Posted | | Mean | Standard Deviation | percent duration | | Duration of each steady state, an average of approximately 60 minutes | | | | ID | Title | Description |
|---|
| OG000 | Et Control | Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations. |
|
| Primary | Percent Duration Without Large Deviation of End-Tidal Oxygen (EtO2) Based on Extraction Algorithm (ALG) | Percent duration of EtAA concentration during steady state maintained within the acceptable limit, which is defined as the greater of 5% of the steady state inhaled anesthetic agent concentration and 0.6% v/v for Desflurane (Des), 0.2% v/v for Sevoflurane (Sev), or 0.1% v/v for Isoflurane (Iso). The percent duration is the weighted average of all steady states for a subject, using the duration of steady state as the weight. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG). | Intent-to-treat population includes all randomized subjects | Posted | | Mean | Standard Deviation | percent duration | | Duration of each steady state, an average of approximately 60 minutes | | | | ID | Title | Description |
|---|
| OG000 | Et Control | Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations. |
|
| Primary | Percent Duration Without Large Deviation of EtO2 Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | Percent duration of EtAA concentration during steady state maintained within the acceptable limit, which is defined as the greater of 5% of the steady state inhaled anesthetic agent concentration and 0.6% v/v for Desflurane (Des), 0.2% v/v for Sevoflurane (Sev), or 0.1% v/v for Isoflurane (Iso). The percent duration is the weighted average of all steady states for a subject, using the duration of steady state as the weight. Values based on clinicians' or Investigators' recorded target values (TGT) | Intent-to-treat population includes all randomized subjects | Posted | | Mean | Standard Deviation | percent duration | | Duration of each steady state, an average of approximately 60 minutes | | | | ID | Title | Description |
|---|
| OG000 | Et Control | Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations. |
|
| Secondary | Efficacy Response Time EtAA Based on Extraction Algorithm (ALG) | Response time: time to reach 90% of the desired change in EtAA steady state mean concentration. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG). | Intent-to-treat population includes all randomized subjects | Posted | | Mean | Standard Deviation | Seconds | | Duration of each steady state, an average of approximately 60 minutes | steady states | steady states | | ID | Title | Description |
|---|
| OG000 | Et Control | Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations. |
|
| Secondary | Efficacy: Response Time for EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | time to reach 90% of the desired change in EtAA and EtO2 steady state mean concentration. Values based on clinicians' or Investigators' recorded values (TGT). | Intent-to-treat population includes all randomized subjects | Posted | | Mean | Standard Deviation | Seconds | | Duration of each steady state, an average of approximately 60 minutes | steady states | steady states | | ID | Title | Description |
|---|
| OG000 | Et Control | Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations. |
|
| Secondary | Efficacy Response Time for EtO2 Based on Extraction Algorithm (ALG) | Response time: time to reach 90% of the desired change in EtO2 steady state mean concentration. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG). | Intent-to-treat population includes all randomized subjects | Posted | | Mean | Standard Deviation | Seconds | | Duration of each steady state, an average of approximately 60 minutes. | steady states | steady states | | ID | Title | Description |
|---|
| OG000 | Et Control | Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations. |
|
| Secondary | Efficacy: Response Time for EtO2 Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | Response time: time to reach 90% of the desired change in EtAA and EtO2 steady state mean concentration. Values based on clinicians' or Investigators' recorded values (TGT). | Intent-to-treat population includes all randomized subjects | Posted | | Mean | Standard Deviation | Seconds | | Duration of each steady state, an average of approximately 60 minutes | steady states | steady states | | ID | Title | Description |
|---|
| OG000 | Et Control | Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations. |
|
| Secondary | Efficacy: Settling Time for EtAA Based on the Extraction Algorithm (ALG) | Settling time: time to achieve the desired EtAA steady state mean concentration. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG). | Intent-to-treat population includes all randomized subjects | Posted | | Mean | Standard Deviation | Seconds | | Duration of each steady state, an average of approximately 60 minutes | steady states | steady states | | ID | Title | Description |
|---|
| OG000 | Et Control | Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations. |
|
| Secondary | Efficacy: Settling Time for EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | Settling time: time to achieve the desired EtAA steady state mean concentration. Values based on clinicians' or Investigators' recorded values (TGT). | Intent-to-treat population includes all randomized subjects | Posted | | Mean | Standard Deviation | Seconds | | Duration of each steady state, an average of approximately 60 minutes | steady states | steady states | | ID | Title | Description |
|---|
| OG000 | Et Control | Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations. |
|
| Secondary | Efficacy: Settling Time for EtO2 Based on the Extraction Algorithm (ALG) | Settling time: time to achieve the desired EtO2 steady state mean concentration. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG). | Intent-to-treat population includes all randomized subjects | Posted | | Mean | Standard Deviation | Seconds | | Duration of each steady state, an average of approximately 60 minutes | steady states | steady states | | ID | Title | Description |
|---|
| OG000 | Et Control | Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations. |
|
| Secondary | Efficacy: Settling Time for EtO2 Based on Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | time to achieve the desired EtO2 steady state mean concentration. Values based on clinicians' or Investigators' recorded values (TGT). | Intent-to-treat population includes all randomized subjects | Posted | | Mean | Standard Deviation | Seconds | | Duration of each steady state, an average of approximately 60 minutes | steady states | steady states | | ID | Title | Description |
|---|
| OG000 | Et Control | Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations. |
|
| Secondary | Efficacy: Overshoot Amount of the Desired EtAA Based on Extraction Algorithm (ALG) | Overshoot amount of the desired EtAA from steady state mean concentration. Command Overshoot is defined as the maximum value beyond the desired end tidal concentration from the start of the step change until the Settling Time. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG). | Intent-to-treat population includes all randomized subjects | Posted | | Mean | Standard Deviation | percent to mean | | Duration of each steady state, an average of approximately 60 minutes | steady states | steady states | | ID | Title | Description |
|---|
| OG000 | Et Control | Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations. |
|
| Secondary | Efficacy: Overshoot Amount of the Desired EtAA Amount Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | Overshoot amount of the desired EtAA from steady state mean concentration. Command Overshoot is defined as the maximum value beyond the desired end tidal concentration from the start of the step change until the Settling Time. Values based on clinicians' or Investigators' recorded values (TGT). | Intent-to-treat population includes all randomized subjects | Posted | | Mean | Standard Deviation | percent to mean | | Duration of each steady state, an average of approximately 60 minutes | steady states | steady states | | ID | Title | Description |
|---|
| OG000 | Et Control | Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations. |
|
| Secondary | Efficacy: Overshoot Amount of Desired EtO2 Amount Based on the Extraction Algorithm (ALG) | Overshoot amount of the desired EtO2 from steady state mean concentration. Command Overshoot is defined as the maximum value beyond the desired end tidal concentration from the start of the step change until the Settling Time. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG). | Intent-to-treat population includes all randomized subjects | Posted | | Mean | Standard Deviation | percent to mean | | Duration of each steady state, an average of approximately 60 minutes | steady states | steady states | | ID | Title | Description |
|---|
| OG000 | Et Control | Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations. |
|
| Secondary | Efficacy: Overshoot Amount of Desired EtO2 Amount Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | Overshoot amount of the desired EtO2 from steady state mean concentration. Command Overshoot is defined as the maximum value beyond the desired end tidal concentration from the start of the step change until the Settling Time. Values based on clinicians' or Investigators' recorded values (TGT). | Intent-to-treat population includes all randomized subjects | Posted | | Mean | Standard Deviation | percent to mean | | Duration of each steady state, an average of approximately 60 minutes | steady states | steady states | | ID | Title | Description |
|---|
| OG000 | Et Control | Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the Et Control option, the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the well being of the subject. Et Control Feature: Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations. |
|
| Secondary | Accuracy of Et Control in Maintaining EtAA Control Between User Set Target and Settling End Tidal Concentrations Based on the Extraction Algorithm (ALG) | Accuracy of Et Control in maintaining EtAA control between user set target and settling end tidal concentrations. Calculated for Et Control arm only. The accuracy measures include absolute difference between steady state and set EtAA concentrations. The acceptable limits defined by the primary endpoint were: 0.1% of Isoflurane, 0.2% for Sevoflurane, 0.6% for Desflurane. As a measure of Absolute Difference between Steady State and Set EtAA Concentration (%). Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG). | Subjects randomized to the ET control arm of the study who underwent surgery | Posted | | Mean | Standard Deviation | Absolute Difference (%) | | Duration of surgery, average of 112.1 minutes (+/- 78.7 minutes) | steady states | steady states | | ID | Title | Description |
|---|
| OG000 | ET Control - Desflurane | Subjects randomized to the ET Control arm of the trial who received Desflurane as their inhaled anesthetic agent. | | OG001 | Et Control - Isoflurane | Subjects randomized to the ET Control arm of the trial who received Isoflurane as their inhaled anesthetic agent. | | OG002 | ET Control - Sevoflurane |
|
| Secondary | Accuracy of ET Control in Maintaining EtAA Control Between User Set Target and Settling End Tidal Concentrations Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | Accuracy of ET Control in maintatining EtAA between user set target and settling end tidal concentrations. Calculated for ET Control arm only. The accuracy measures include absolute difference between steady state and set EtAA concentrations. The acceptable limits defined by the primary endpoint were: 0.1% of Isoflurane, 0.2% for Sevoflurane, 0.6% for Desflurane. Values based on clinicians' or Investigators' recorded values (TGT). | Subjects Randomized to the ET control arm of the study who underwent surgery | Posted | | Mean | Standard Deviation | Absolute Difference (%) | | Duration of Surgery | steady states | steady states | | ID | Title | Description |
|---|
| OG000 | ET Control - Desflurane | Subjects randomized to the ET Control arm of the trial who received Desflurane as their inhaled anesthetic agent. | | OG001 | Et Control - Isoflurane | Subjects randomized to the ET Control arm of the trial who received Isoflurane as their inhaled anesthetic agent. | | OG002 | ET Control - Sevoflurane | Subjects randomized to the ET Control arm of the trial who received Sevoflurane as their inhaled anesthetic agent. |
|
| Secondary | Accuracy of Et Control in Maintaining EtO2 Between User Set Target and Settling End Tidal Concentrations Based on the Extraction Algorithm (ALG) | Accuracy of Et Control in maintaining EtO2 control between user set target and settling end tidal concentrations. Calculated for Et Control arm only. outcome measures the absolute difference between Steady State and Set EtO2 Concentrations. The acceptable limit defined by the primary endpoint was < 5% v/v. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG). | Subjects randomized to the ET control arm of the study who underwent surgery. | Posted | | Mean | Standard Deviation | Absolute Difference (%) | | Duration of surgery, average of 112.1 minutes (+/- 78.7 minutes) | steady states | steady states | | ID | Title | Description |
|---|
| OG000 | ET Control - Desflurane | Subjects randomized to the ET Control arm of the trial who received Desflurane as their inhaled anesthetic agent. | | OG001 | Et Control - Isoflurane | Subjects randomized to the ET Control arm of the trial who received Isoflurane as their inhaled anesthetic agent. | | OG002 | ET Control - Sevoflurane | Subjects randomized to the ET Control arm of the trial who received Sevoflurane as their inhaled anesthetic agent. |
|
| Secondary | Accuracy of Et Control in Maintaining EtO2 Between User Set Target and Settling End Tidal Concentrations Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) | Accuracy of Et Control in maintaining EtO2 control between user set target and settling end tidal concentrations. Calculated for Et Control arm only. outcome measures the absolute difference between Steady State and Set EtO2 Concentrations. The acceptable limit defined by the primary endpoint was < 5% v/v. Values based on clinicians' or Investigators' recorded values (TGT). | Subjects randomized to the ET control arm of the study who underwent surgery | Posted | | Mean | Standard Deviation | Absolute Difference (%) | | Duration of surgery, average of 112.1 minutes (+/- 78.7 minutes) | steady states | steady states | | ID | Title | Description |
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| OG000 | ET Control - Desflurane | Subjects randomized to the ET Control arm of the trial who received Desflurane as their inhaled anesthetic agent. | | OG001 | Et Control - Isoflurane | Subjects randomized to the ET Control arm of the trial who received Isoflurane as their inhaled anesthetic agent. | | OG002 | ET Control - Sevoflurane | Subjects randomized to the ET Control arm of the trial who received Sevoflurane as their inhaled anesthetic agent. |
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| Other Pre-specified | Inhaled Anesthetic Agent | Usage of inhaled anesthetic agent | | Not Posted | | | | | | Duration of Procedure | | Participants | | | | |
| Other Pre-specified | User Interactions | Number of user interactions | | Not Posted | | | | | | Duration of Procedure | | Participants | | | | |
| Other Pre-specified | Discharge From the Operating Room | Time to discharge from the operating room | | Not Posted | | | | | | End of surgery to time of last breath | | Participants | | | | |