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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR000135 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Westmed, Inc. | UNKNOWN |
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The purpose of this study is to evaluate patients' temperatures after using one of two ventilator circuits (breathing systems): the ANAPOD™ Heat and Humidification System (ANAPOD™ system) or the standard ventilator circuit with a heat-moisture exchanger (standard ventilator). The ANAPOD™ system will provide additional heat and humidity to patients through their breathing tube while the standard ventilator will not. The investigators are doing this research study to find out if the ventilator circuit providing additional heat and humidity will keep patients warmer during surgery and after surgery.
Patients were randomly assigned to either the treatment group or the control group prior to surgery. Prior to induction, patients in the control group were given inspiratory gas at ambient air temperature (20-22 degrees Celsius) and patients in the treatment group were given inspiratory gas at warmed temperatures (40-41 degrees Celsius). All patients were induced with general anesthesia in the supine position and repositioned prone following endotracheal intubation and placement of an esophageal stethoscope with a temperature sensor, as per usual hospital practice. Esophageal temperatures were recorded within 30 minutes of the baseline esophageal temperature and every 10 minutes thereafter for the first hour post-induction. All patients had a blanket and forced air warming applied to their lower extremities and upper back at 43 degrees Celsius after draping. All patients had esophageal temperature measurements recorded every 30 minutes until the patient was repositioned supine. Core temperatures were recorded four hours post-induction for those patients reaching that timeframe.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heated Ventilator Circuit | Experimental | Heated and humidified inspired gases using the ANAPOD™ Heat and Humidification System (Westmed; Tucson, Arizona, USA) circuit prior to induction of general anesthesia in addition to standard ventilation and temperature management. |
|
| Standard Ventilator Circuit | Active Comparator | Standard ventilation and temperature management. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heated Ventilator Circuit | Device | active heat and humidification during anesthesia by warming inspire gases without a heat-moisture exchanger |
|
| Measure | Description | Time Frame |
|---|---|---|
| Core Body Temperature | Core body temperature will be taken in the esophagus. The last recorded esophageal temperature will be used for surgeries not reaching 3 hours duration. | Approximately four hours post-induction of general anesthesia (or last recorded temperature) |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative Core Temperatures Post-induction | Core body temperature will be taken in the esophagus after general anesthesia induction. | Approximately 30 minutes, 60 minutes, 120 minutes post-induction of general anesthesia |
| Number of Subjects With Post-operative Shivering |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean M Guyer, DNP | Mayo Clinic | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Heated Ventilator Circuit | Heated and humidified inspired gases using the ANAPOD™ Heat and Humidification System (Westmed; Tucson, Arizona, USA) circuit prior to induction of general anesthesia in addition to standard ventilation and temperature management. Heated Ventilator Circuit: active heat and humidification during anesthesia by warming inspire gases without a heat-moisture exchanger |
| FG001 | Standard Ventilator Circuit | Standard ventilation and temperature management Standard Ventilator Circuit: no active heat and humidification during anesthesia |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.
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| ID | Title | Description |
|---|---|---|
| BG000 | Heated Ventilator Circuit | Heated and humidified inspired gases using the ANAPOD™ Heat and Humidification System (Westmed; Tucson, Arizona, USA) circuit prior to induction of general anesthesia in addition to standard ventilation and temperature management. Heated Ventilator Circuit: active heat and humidification during anesthesia by warming inspire gases without a heat-moisture exchanger |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Core Body Temperature | Core body temperature will be taken in the esophagus. The last recorded esophageal temperature will be used for surgeries not reaching 3 hours duration. | One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record. | Posted | Mean | Standard Deviation | degrees Celsius | Approximately four hours post-induction of general anesthesia (or last recorded temperature) |
|
30 days.
One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Heated Ventilator Circuit | Heated and humidified inspired gases using the ANAPOD™ Heat and Humidification System (Westmed; Tucson, Arizona, USA) circuit prior to induction of general anesthesia in addition to standard ventilation and temperature management. Heated Ventilator Circuit: active heat and humidification during anesthesia by warming inspire gases without a heat-moisture exchanger |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Systematic Assessment |
The study was not blinded; investigators were unable to verify exact placement of the esophageal temperature probe; post-op shivering assessments and both OR and ANAPOD temperatures were not consistently recorded at regular intervals.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jean M. Guyer, DNP | Mayo Clinic | 507-255-5716 | guyer.jean@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 26, 2015 | Mar 23, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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randomized, trial (treatment or no treatment)
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Patients were randomly assigned to either the treatment group or the control group prior to surgery. Group randomization was performed using a randomization schedule prepared by the Division of Clinical Statistics with patients randomized in blocks of four. For consented and enrolled patients on the day of surgery in the admit areas, a participant was assigned the next sequential participant ID number and the appropriate sealed envelope was opened to reveal the participant's randomized intervention. This occurred before the patient was transferred to the operating suite. Individuals who performed data analysis were blinded to treatment group.
|
| Standard Ventilator Circuit | Device | no active heat and humidification during anesthesia |
|
|
Shivering in the post-anesthesia care unit will be assessed using the Bedside Shivering Assessment Scale. This is a 4 point scale and rate shivering as the following: absent, mild, moderate, or severe. Only the highest degree of patient shivering was used in the analysis. |
| Approximately 2 hours after completion of the surgery |
| Hospital Length of Stay | Number of days in the hospital | Surgery to hospital discharge |
| Overall Post-operative Temperature | Temperature at Post Anesthesia Care Unit (PACU) arrival. | PACU arrival |
| Number of Participants With Transfusion Within 48 Hours of Surgery | Requirement of blood transfusion within 48 hours of surgery | Within 48 hours of surgery |
| Estimated Blood Loss | The estimated blood loss per case was determined by the anesthesia provider by measuring the volume of blood in the suction canister while taking into account the amount of irrigation solution used. | duration of surgery |
| BG001 | Standard Ventilator Circuit | Standard ventilation and temperature management Standard Ventilator Circuit: no active heat and humidification during anesthesia |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record. | Count of Participants | Participants |
|
| Race (NIH/OMB) | One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record. | Count of Participants | Participants |
|
| Region of Enrollment | One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record. | Count of Participants | Participants |
|
| BMI | One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record. | Mean | Standard Deviation | kg/m^2 |
|
| American Society of Anesthesiologists (ASA) Status | The ASA physical status classification system is a system for assessing the fitness of patients before surgery. There are six categories in the classification system, the higher the number, the more severe illness is indicated. I=normal healthy patient, II=patient with mild systemic disease, III=a patient with severe systemic disease, IV=a patient with severe systemic disease that is a constant threat to life, V=a moribund patient who is not expected to survive without the operation, VI=a declared brain-dead patient whose organs are being removed for donor purposes. | One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record. | Count of Participants | Participants |
|
| OG001 | Standard Ventilator Circuit | Standard ventilation and temperature management Standard Ventilator Circuit: no active heat and humidification during anesthesia |
|
|
|
| Secondary | Intraoperative Core Temperatures Post-induction | Core body temperature will be taken in the esophagus after general anesthesia induction. | One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record. Data was obtained from 33 subjects in the treatment group at 60 minutes post-induction. | Posted | Mean | Standard Deviation | degrees Celsius | Approximately 30 minutes, 60 minutes, 120 minutes post-induction of general anesthesia |
|
|
|
|
| Secondary | Number of Subjects With Post-operative Shivering | Shivering in the post-anesthesia care unit will be assessed using the Bedside Shivering Assessment Scale. This is a 4 point scale and rate shivering as the following: absent, mild, moderate, or severe. Only the highest degree of patient shivering was used in the analysis. | One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record. | Posted | Count of Participants | Participants | Approximately 2 hours after completion of the surgery |
|
|
|
|
| Secondary | Hospital Length of Stay | Number of days in the hospital | One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record. | Posted | Median | Inter-Quartile Range | number of days | Surgery to hospital discharge |
|
|
|
|
| Secondary | Overall Post-operative Temperature | Temperature at Post Anesthesia Care Unit (PACU) arrival. | One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record. Data was obtained from 32 subjects in the treatment group. | Posted | Mean | Standard Deviation | degrees Celsius | PACU arrival |
|
|
|
|
| Secondary | Number of Participants With Transfusion Within 48 Hours of Surgery | Requirement of blood transfusion within 48 hours of surgery | One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record. | Posted | Count of Participants | Participants | Within 48 hours of surgery |
|
|
|
|
| Secondary | Estimated Blood Loss | The estimated blood loss per case was determined by the anesthesia provider by measuring the volume of blood in the suction canister while taking into account the amount of irrigation solution used. | One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record. | Posted | Median | Inter-Quartile Range | milliters | duration of surgery |
|
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 5 |
| 35 |
| EG001 | Standard Ventilator Circuit | Standard ventilation and temperature management Standard Ventilator Circuit: no active heat and humidification during anesthesia | 0 | 34 | 0 | 34 | 3 | 34 |
| Blood clot | Blood and lymphatic system disorders | Systematic Assessment |
|
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| ~60 minutes |
|
|
| ~120 minutes |
|
|
| t-test, 2 sided |
| 0.853 |
| Median Difference (Final Values) |
| 0.0 |
| 2-Sided |
| 95 |
| -0.2 |
| 0.3 |
| Superiority |
| ~120 minutes post-induction | t-test, 2 sided | 0.986 | Median Difference (Final Values) | 0.0 | 2-Sided | 95 | -0.2 | 0.2 | Superiority |