| Primary | Time Taken From Initiation of Induction to the First Airway Intervention | | 16 participants in the Group B: SuperNO2VAâ„¢EtCO2 needed airway intervention. 29 participants in the Group A: Standard care with a facemask needed airway intervention. Only the participants who needed airway intervention were analyzed for this outcome measure. | Posted | | Median | Inter-Quartile Range | minutes | | From Initiation of Induction to the First Airway Intervention (about 16 minutes) | | | | ID | Title | Description |
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| OG000 | Group B: SuperNO2VAâ„¢EtCO2 | SuperNO2VAâ„¢EtCO2 (Nasal Oxygenating Ventilating Apparatus): The anesthesia provider will attach the SuperNO2VAâ„¢ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VAâ„¢EtCO2 (Nasal Oxygenating Ventilating Apparatus) | | OG001 | Group A: Standard Care With a Facemask. | Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM) |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0005(3 to 11)
- OG00110(4.5 to 15.5)
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| Secondary | Amount of Propofol Administered During Induction | | | Posted | | Mean | Inter-Quartile Range | milligrams | | Within 5 minutes of the start of anesthesia | | | | ID | Title | Description |
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| OG000 | Group B: SuperNO2VAâ„¢EtCO2 | SuperNO2VAâ„¢EtCO2 (Nasal Oxygenating Ventilating Apparatus): The anesthesia provider will attach the SuperNO2VAâ„¢ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VAâ„¢EtCO2 (Nasal Oxygenating Ventilating Apparatus) | | OG001 | Group A: Standard Care With a Facemask. | Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM) |
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| Secondary | Total Amount of Propofol Administered During the Procedure | | | Posted | | Median | Inter-Quartile Range | milligrams | | during the procedure (about 45 minutes) | | | | ID | Title | Description |
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| OG000 | Group B: SuperNO2VAâ„¢EtCO2 | SuperNO2VAâ„¢EtCO2 (Nasal Oxygenating Ventilating Apparatus): The anesthesia provider will attach the SuperNO2VAâ„¢ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VAâ„¢EtCO2 (Nasal Oxygenating Ventilating Apparatus) | | OG001 | Group A: Standard Care With a Facemask. | Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM) |
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| Secondary | Change in Alertness of Subject as Assessed by the Modified Observer's Assessment of Alertness/Sedation Scale (MOAAS) | This is scored from 0(no response)-5(response to your name spoken in a normal tone), a higher number indicating more alertness | Data were not collected for this outcome measure because the assessment was not done by the observers. As a result, 0 observers completed the assessment, and therefore, no participants were analyzed in either study arm. | Posted | | | | | | prior to endoscopic intubation,during the procedure | | | | ID | Title | Description |
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| OG000 | Group B: SuperNO2VAâ„¢EtCO2 | SuperNO2VAâ„¢EtCO2 (Nasal Oxygenating Ventilating Apparatus): The anesthesia provider will attach the SuperNO2VAâ„¢ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VAâ„¢EtCO2 (Nasal Oxygenating Ventilating Apparatus) | | OG001 | Group A: Standard Care With a Facemask. | Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM) |
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| Secondary | Time Taken From Induction to Endoscopic Insertion | | | Posted | | Median | Inter-Quartile Range | minutes | | within 10 minutes of start of sedation | | | | ID | Title | Description |
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| OG000 | Group B: SuperNO2VAâ„¢EtCO2 | SuperNO2VAâ„¢EtCO2 (Nasal Oxygenating Ventilating Apparatus): The anesthesia provider will attach the SuperNO2VAâ„¢ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VAâ„¢EtCO2 (Nasal Oxygenating Ventilating Apparatus) | | OG001 | Group A: Standard Care With a Facemask. | Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM) |
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| Secondary | Incidence of Procedural Interruptions as Assessed by the Number of Times the Endoscope is Removed From the Patient | | | Posted | | Number | | number of times endoscope is removed | | From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes) | | | | ID | Title | Description |
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| OG000 | Group B: SuperNO2VAâ„¢EtCO2 | SuperNO2VAâ„¢EtCO2 (Nasal Oxygenating Ventilating Apparatus): The anesthesia provider will attach the SuperNO2VAâ„¢ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VAâ„¢EtCO2 (Nasal Oxygenating Ventilating Apparatus) | | OG001 | Group A: Standard Care With a Facemask. | Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM) |
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| Secondary | Duration of Procedural Interruptions as Assessed by the Length of Time the Endoscope is Removed From the Patient | | Zero participants had a procedural interruption. | Posted | | | | | | From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes) | | | | ID | Title | Description |
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| OG000 | Group B: SuperNO2VAâ„¢EtCO2 | SuperNO2VAâ„¢EtCO2 (Nasal Oxygenating Ventilating Apparatus): The anesthesia provider will attach the SuperNO2VAâ„¢ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VAâ„¢EtCO2 (Nasal Oxygenating Ventilating Apparatus) | | OG001 | Group A: Standard Care With a Facemask. | Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM) |
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| Secondary | Number of Participants Who Received Airway Maneuvers | | | Posted | | Count of Participants | | Participants | | From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes) | | | | ID | Title | Description |
|---|
| OG000 | Group B: SuperNO2VAâ„¢EtCO2 | SuperNO2VAâ„¢EtCO2 (Nasal Oxygenating Ventilating Apparatus): The anesthesia provider will attach the SuperNO2VAâ„¢ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VAâ„¢EtCO2 (Nasal Oxygenating Ventilating Apparatus) | | OG001 | Group A: Standard Care With a Facemask. | Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM) |
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| Secondary | Time Taken for Airway Maneuvers | | 16 participants who received airway maneuvers in the Group B: SuperNO2VAâ„¢EtCO2 arm were analyzed for the outcome measure. 29 participants who received airway maneuvers in the Group A: Standard care with a facemask arm were analyzed for the outcome measure. | Posted | | Median | Inter-Quartile Range | seconds | | From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes) | | | | ID | Title | Description |
|---|
| OG000 | Group B: SuperNO2VAâ„¢EtCO2 | SuperNO2VAâ„¢EtCO2 (Nasal Oxygenating Ventilating Apparatus): The anesthesia provider will attach the SuperNO2VAâ„¢ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VAâ„¢EtCO2 (Nasal Oxygenating Ventilating Apparatus) | | OG001 | Group A: Standard Care With a Facemask. | Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM) |
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| Secondary | Reason for Airway Maneuvers | | 16 participants in the Group B: SuperNO2VAâ„¢EtCO2 needed airway intervention. 29 participants in the Group A: Standard care with a facemask needed airway intervention. Only the participants who needed airway intervention were analyzed for this outcome measure. | Posted | | Count of Participants | | Participants | | From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes) | | | | ID | Title | Description |
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| OG000 | Group B: SuperNO2VAâ„¢EtCO2 | SuperNO2VAâ„¢EtCO2 (Nasal Oxygenating Ventilating Apparatus): The anesthesia provider will attach the SuperNO2VAâ„¢ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VAâ„¢EtCO2 (Nasal Oxygenating Ventilating Apparatus) | | OG001 | Group A: Standard Care With a Facemask. | Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM) |
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| Secondary | Time Taken for the Entire Procedure | | | Posted | | Median | Inter-Quartile Range | minutes | | from start of procedure to end of procedure (about 45 minutes) | | | | ID | Title | Description |
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| OG000 | Group B: SuperNO2VAâ„¢EtCO2 | SuperNO2VAâ„¢EtCO2 (Nasal Oxygenating Ventilating Apparatus): The anesthesia provider will attach the SuperNO2VAâ„¢ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VAâ„¢EtCO2 (Nasal Oxygenating Ventilating Apparatus) | | OG001 | Group A: Standard Care With a Facemask. | Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM) |
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| Secondary | Recovery Time as Assessed by the Time When Subject Was Ready for Discharge | | | Posted | | Median | Inter-Quartile Range | minutes | | at time of discharge( about one hour from end of procedure) | | | | ID | Title | Description |
|---|
| OG000 | Group B: SuperNO2VAâ„¢EtCO2 | SuperNO2VAâ„¢EtCO2 (Nasal Oxygenating Ventilating Apparatus): The anesthesia provider will attach the SuperNO2VAâ„¢ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VAâ„¢EtCO2 (Nasal Oxygenating Ventilating Apparatus) | | OG001 | Group A: Standard Care With a Facemask. | Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM) |
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| Secondary | Recovery Time as Assessed by the Actual Time When Subject Was Discharged | | | Posted | | Median | Inter-Quartile Range | minutes | | at time of discharge( about one and a half hour from end of procedure) | | | | ID | Title | Description |
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| OG000 | Group B: SuperNO2VAâ„¢EtCO2 | SuperNO2VAâ„¢EtCO2 (Nasal Oxygenating Ventilating Apparatus): The anesthesia provider will attach the SuperNO2VAâ„¢ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VAâ„¢EtCO2 (Nasal Oxygenating Ventilating Apparatus) | | OG001 | Group A: Standard Care With a Facemask. | Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM) |
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| Secondary | Patient Satisfaction as Assessed by the Visual Analog Scale (VAS) | This will be scored from 0-10, a higher score indicating more satisfaction | Data were not collected from 3 participants in the Group B: SuperNO2VAâ„¢EtCO2 arm because the participants did not complete the survey. Data were not collected from 1 participant in the Group A: Standard care with a facemask arm because the participant did not complete the survey. | Posted | | Median | Inter-Quartile Range | score on a scale | | at time of discharge(about one hour from end of procedure) | | | | ID | Title | Description |
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| OG000 | Group B: SuperNO2VAâ„¢EtCO2 | SuperNO2VAâ„¢EtCO2 (Nasal Oxygenating Ventilating Apparatus): The anesthesia provider will attach the SuperNO2VAâ„¢ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VAâ„¢EtCO2 (Nasal Oxygenating Ventilating Apparatus) | | OG001 | Group A: Standard Care With a Facemask. | Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM) |
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| Secondary | Number of Participants That Tolerated the SuperNO2VAâ„¢EtCO2 | | | Posted | | Count of Participants | | Participants | | from start of procedure to end of procedure (about 45 minutes) | | | | ID | Title | Description |
|---|
| OG000 | Group B: SuperNO2VAâ„¢EtCO2 | SuperNO2VAâ„¢EtCO2 (Nasal Oxygenating Ventilating Apparatus): The anesthesia provider will attach the SuperNO2VAâ„¢ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VAâ„¢EtCO2 (Nasal Oxygenating Ventilating Apparatus) |
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| Secondary | Anesthesiologist Satisfaction Score as Assessed by the Visual Analog Scale (VAS) | This will be scored from 0-10, a higher score indicating more satisfaction | | Posted | | Median | Inter-Quartile Range | score on a scale | | end of procedure (about 45 minutes from start) | | | | ID | Title | Description |
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| OG000 | Group B: SuperNO2VAâ„¢EtCO2 | SuperNO2VAâ„¢EtCO2 (Nasal Oxygenating Ventilating Apparatus): The anesthesia provider will attach the SuperNO2VAâ„¢ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VAâ„¢EtCO2 (Nasal Oxygenating Ventilating Apparatus) | | OG001 | Group A: Standard Care With a Facemask. | Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM) |
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| Secondary | Number of Participants That Had Incidences of Cardiac Complications | | | Posted | | Count of Participants | | Participants | | during the procedure (about 45 minutes) | | | | ID | Title | Description |
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| OG000 | Group B: SuperNO2VAâ„¢EtCO2 | SuperNO2VAâ„¢EtCO2 (Nasal Oxygenating Ventilating Apparatus): The anesthesia provider will attach the SuperNO2VAâ„¢ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VAâ„¢EtCO2 (Nasal Oxygenating Ventilating Apparatus) | | OG001 | Group A: Standard Care With a Facemask. | Standard care with a facemask.: The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM) |
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