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Study terminated due to financial status of sponsor.
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We propose a study in which we compare two intraoperative active warming devices for maintenance of normothermia in patients undergoing colorectal surgery. A novel underbody resistive warming mattress (VitaHeat) will be compared to the forced air warming blanket (3M Bair Hugger) that is currently used in our institution. Our hypothesis is that the underbody resistive warming mattress will be equally effective as forced air warming in maintaining normothermia in colorectal surgery.
Stratified randomization will be performed using a computerized randomization table where the strata will be type of surgery (open vs closed) and the treatment will be forced air blanket or underbody mattress warming device. This will allow equal groups of both warming devices in both types of surgery.
Group 1: Patients will receive active warming via a heating mattress (VitaHEAT Medical) placed on the OR table with two thin sheets between the patient and the device; one covering the mattress and the other used as the draw sheet as usual practice. The device will be turned on 10 minutes prior to the patients' arrival to the operating room table. Patients' upper body will be covered with blankets. To increase skin surface contact with the mattress any blankets remaining under the patients' chest or head will be removed after intubation and replaced with a donut.
Group 2: Patients will receive standard forced air warming applied to the upper body and turned on after the patient is prepped and draped. These warmers will be placed directly in contact with the skin without any intervening insulation.
Both groups will have IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C.
Participation in the study is voluntary. The patients may choose not to enroll in the research. Patients who choose not to enroll will use the standard forced air warmer.
Preoperative and postoperative temperatures will be measured orally. Intraoperative core and skin temperatures will be monitored continuously at 1 minute intervals using an esophageal probe and skin temperature probe using a skin temp probe placed on the great toe and covered to prevent any contact with the warming devices.
Intraoperative period: The participants temperature will be monitored and documented at prescribed times.
Postoperative period: The participants will have temperature monitored in the post anesthesia care area.
Participation in this study will last for 30 days following surgery at which point study member will call patient for a 2-4 minute phone call.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: VitaHeat | Active Comparator | Patients in group one will be warmed perioperatively with the VitaHeat mattress and IV fluid warmers once they are in the operating room. |
|
| Group 2: Bair Hugger | Active Comparator | Patients in group two will be warmed perioperatively with the upper body bair hugger and IV fluid warmers once they are in the operating room. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group 1: VitaHeat | Device | Patients will receive active warming via a heating mattress (VitaHEAT Medical) placed on the OR table with two thin sheets between the patient and the device; one covering the mattress and the other used as the draw sheet as usual practice. The device will be turned on 10 minutes prior to the patients' arrival to the operating room table. Patients' upper body will be covered with blankets. To increase skin surface contact with the mattress any blankets remaining under the patients' chest or head will be removed after intubation and replaced with a donut. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C. |
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Outcome Measure Will be the Percentage of Intraoperative Time the Participants Body Temperature is Above 36 Degrees Celcius. | The total percent of intraoperative time (time in the operating room) that the body temperature of the participant is above 36 degrees celcius measured using an esophageal temperature probe. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Post Operative Temperature on Admission to Post Operative Care Unit (PACU) | Oral temperature in degrees celcius immediately after admission to the PACU after the planned surgical procedure has been completed. | Immediately after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meltim Yilmaz, M.D. | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States | ||
| Northwestern University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26775126 | Background | Sessler DI. Perioperative thermoregulation and heat balance. Lancet. 2016 Jun 25;387(10038):2655-2664. doi: 10.1016/S0140-6736(15)00981-2. Epub 2016 Jan 8. | |
| 19137809 | Background | Torossian A. Thermal management during anaesthesia and thermoregulation standards for the prevention of inadvertent perioperative hypothermia. Best Pract Res Clin Anaesthesiol. 2008 Dec;22(4):659-68. doi: 10.1016/j.bpa.2008.07.006. |
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50 patients were consented to participate, 4 were withdrawn from the study to leave an analysis sample of 46 subjects. The study was terminated early due to financial constraints from the sponsor.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: VitaHeat | Patients in group one will be warmed perioperatively with the VitaHeat mattress and IV fluid warmers once they are in the operating room. Group 1: VitaHeat: Patients will receive active warming via a heating mattress (VitaHEAT Medical) placed on the OR table with two thin sheets between the patient and the device; one covering the mattress and the other used as the draw sheet as usual practice. The device will be turned on 10 minutes prior to the patients' arrival to the operating room table. Patients' upper body will be covered with blankets. To increase skin surface contact with the mattress any blankets remaining under the patients' chest or head will be removed after intubation and replaced with a donut. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C. |
| FG001 | Group 2: Bair Hugger | Patients in group two will be warmed perioperatively with the upper body bair hugger and IV fluid warmers once they are in the operating room. Group 2: Bair Hugger: Patients will receive standard forced air warming applied to the upper body and turned on after the patient is prepped and draped. These warmers will be placed directly in contact with the skin without any intervening insulation. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
1 subjects in the Vitaheat group and 3 subjects in the Bair Hugger group were not included in the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: VitaHeat | Patients in group one will be warmed perioperatively with the VitaHeat mattress and IV fluid warmers once they are in the operating room. Group 1: VitaHeat: Patients will receive active warming via a heating mattress (VitaHEAT Medical) placed on the OR table with two thin sheets between the patient and the device; one covering the mattress and the other used as the draw sheet as usual practice. The device will be turned on 10 minutes prior to the patients' arrival to the operating room table. Patients' upper body will be covered with blankets. To increase skin surface contact with the mattress any blankets remaining under the patients' chest or head will be removed after intubation and replaced with a donut. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | The Primary Outcome Measure Will be the Percentage of Intraoperative Time the Participants Body Temperature is Above 36 Degrees Celcius. | The total percent of intraoperative time (time in the operating room) that the body temperature of the participant is above 36 degrees celcius measured using an esophageal temperature probe. | Posted | Mean | Full Range | percent time | 1 day |
|
Up to 30 days after surgical procedure.
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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 | Group 1: VitaHeat | Patients in group one will be warmed perioperatively with the VitaHeat mattress and IV fluid warmers once they are in the operating room. Group 1: VitaHeat: Patients will receive active warming via a heating mattress (VitaHEAT Medical) placed on the OR table with two thin sheets between the patient and the device; one covering the mattress and the other used as the draw sheet as usual practice. The device will be turned on 10 minutes prior to the patients' arrival to the operating room table. Patients' upper body will be covered with blankets. To increase skin surface contact with the mattress any blankets remaining under the patients' chest or head will be removed after intubation and replaced with a donut. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | Myocardial infarctio | Systematic Assessment | Myocardial infarction during the planned surgical procedure. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Renal and urinary disorders | Urinary tract | Systematic Assessment | Urinary tract infection documented after surgical procedure to the time of discharge from the hospital. |
The limitation of the results presented is that we did not reach full enrollment as referenced in the protocol because the sponsor terminated the study early.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meltem Yilmaz, MD | Northwestern University | 312-695-0061 | m-yilmaz@northwestern.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 | Mar 14, 2018 | Jan 7, 2020 | Prot_SAP_000.pdf |
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|
| Group 2: Bair Hugger | Device | Patients will receive standard forced air warming applied to the upper body and turned on after the patient is prepped and draped. These warmers will be placed directly in contact with the skin without any intervening insulation. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C. |
|
| Chicago |
| Illinois |
| 60611 |
| United States |
| 8317751 | Background | Sessler DI, Schroeder M. Heat loss in humans covered with cotton hospital blankets. Anesth Analg. 1993 Jul;77(1):73-7. doi: 10.1213/00000539-199307000-00014. |
| 8024134 | Background | Cheney FW, Posner KL, Caplan RA, Gild WM. Burns from warming devices in anesthesia. A closed claims analysis. Anesthesiology. 1994 Apr;80(4):806-10. doi: 10.1097/00000542-199404000-00012. |
| 15114200 | Background | Taguchi A, Ratnaraj J, Kabon B, Sharma N, Lenhardt R, Sessler DI, Kurz A. Effects of a circulating-water garment and forced-air warming on body heat content and core temperature. Anesthesiology. 2004 May;100(5):1058-64. doi: 10.1097/00000542-200405000-00005. |
| 11605926 | Background | Janicki PK, Higgins MS, Janssen J, Johnson RF, Beattie C. Comparison of two different temperature maintenance strategies during open abdominal surgery: upper body forced-air warming versus whole body water garment. Anesthesiology. 2001 Oct;95(4):868-74. doi: 10.1097/00000542-200110000-00014. |
| 1610573 | Background | Hynson JM, Sessler DI. Intraoperative warming therapies: a comparison of three devices. J Clin Anesth. 1992 May-Jun;4(3):194-9. doi: 10.1016/0952-8180(92)90064-8. |
| 15312013 | Background | Brauer A, Weyland W, Kazmaier S, Trostdorf U, Textor Z, Hellige G, Braun U. Efficacy of postoperative rewarming after cardiac surgery. Ann Thorac Cardiovasc Surg. 2004 Jun;10(3):171-7. |
| 9702617 | Background | Smith CE, Desai R, Glorioso V, Cooper A, Pinchak AC, Hagen KF. Preventing hypothermia: convective and intravenous fluid warming versus convective warming alone. J Clin Anesth. 1998 Aug;10(5):380-5. doi: 10.1016/s0952-8180(98)00049-x. |
| 12760996 | Background | Negishi C, Hasegawa K, Mukai S, Nakagawa F, Ozaki M, Sessler DI. Resistive-heating and forced-air warming are comparably effective. Anesth Analg. 2003 Jun;96(6):1683-1687. doi: 10.1213/01.ANE.0000062770.73862.B7. |
| 23989047 | Background | Melton GB, Vogel JD, Swenson BR, Remzi FH, Rothenberger DA, Wick EC. Continuous intraoperative temperature measurement and surgical site infection risk: analysis of anesthesia information system data in 1008 colorectal procedures. Ann Surg. 2013 Oct;258(4):606-12; discussion 612-3. doi: 10.1097/SLA.0b013e3182a4ec0f. |
| BG001 | Group 2: Bair Hugger | Patients in group two will be warmed perioperatively with the upper body bair hugger and IV fluid warmers once they are in the operating room. Group 2: Bair Hugger: Patients will receive standard forced air warming applied to the upper body and turned on after the patient is prepped and draped. These warmers will be placed directly in contact with the skin without any intervening insulation. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight in kilogram (kg) | Mean | Full Range | kilograms |
|
| Length of hospital stay in days | Length of hospital stay. This is based the date of surgical procedure to the date of discharge from the hospital. | Mean | Full Range | Days |
|
| OG001 | Group 2: Bair Hugger | Patients in group two will be warmed perioperatively with the upper body bair hugger and IV fluid warmers once they are in the operating room. Group 2: Bair Hugger: Patients will receive standard forced air warming applied to the upper body and turned on after the patient is prepped and draped. These warmers will be placed directly in contact with the skin without any intervening insulation. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C. |
|
|
| Secondary | Post Operative Temperature on Admission to Post Operative Care Unit (PACU) | Oral temperature in degrees celcius immediately after admission to the PACU after the planned surgical procedure has been completed. | 1 subject from the VITAheat group and 3 subjects from the Bair hugger group were excluded from analysis. | Posted | Mean | Full Range | Degrees Celcius | Immediately after surgery |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 3 |
| 25 |
| EG001 | Group 2: Bair Hugger | Patients in group two will be warmed perioperatively with the upper body bair hugger and IV fluid warmers once they are in the operating room. Group 2: Bair Hugger: Patients will receive standard forced air warming applied to the upper body and turned on after the patient is prepped and draped. These warmers will be placed directly in contact with the skin without any intervening insulation. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C. | 0 | 21 | 0 | 21 | 2 | 21 |
|
| Cardiac Arrest | Cardiac disorders | Cardiac arrest | Systematic Assessment | Cardiac arrest during the period of surgical start to the day of discharge. |
|
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Pneumonia | Systematic Assessment | Pneumonia reported during the time postsurgical to day of discharge from the hospital |
|
| Bladder injury | Renal and urinary disorders | Bladder injury | Systematic Assessment | Bladder injury during the perioperative period. |
|
| Deep vein thrombosis | Vascular disorders | Deep vein thrombisis | Systematic Assessment | Deep vein thrombosis identified during the period of surgical date to the day of discharge,. |
|
| Device burn injury to skin | Respiratory, thoracic and mediastinal disorders | burn | Systematic Assessment | Burn injury to skin related to the warming devices from surgical start time to end of surgery. |
|
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