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Preoperative Warming Prevents Postoperative Hypothermia in Laparoscopic Gynecologic Surgery. A Randomized Control Trial

Primary Purpose

Hypothermia Following Anesthesia, Hypothermia, Hypothermia, Accidental

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
3M Bair Paws Warming System
Sponsored by
Michael Garron Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypothermia Following Anesthesia

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA I-III
  • undergoing elective laparoscopic gynecological surgical procedures
  • expected duration >60 minutes
  • BMI 18-45

Exclusion Criteria:

  • Current fever (temperature>38.1°C)
  • active endocrine disorders were exclusion criteria

Sites / Locations

  • Toronto East General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prewarming group

Control group

Arm Description

Prewarmed for 20 minutes prior to OR using 3M Bair Paws System, a forced air warming blanket. This warming blanket was then used intraoperatively throughout the case.

Patients received standard care, which is no active prewarming prior to OR. A full body, forced air warming blanket (same as treatment group) was used intraoperatively throughout the case.

Outcomes

Primary Outcome Measures

Oral temperature immediately postoperatively
Immediate postoperative oral temperature on admission to the post-anesthetic care unit.

Secondary Outcome Measures

Oral temperature 30 minutes postoperatively
Oral temperature 30 minutes after admission to the post-anesthetic care unit.
Oral temperature at discharge from post-anesthetic care unit
Oral temperature upon discharge from the post-anesthetic care unit.
11-point Pain score
11-point VAS pain score postoperatively measured 30 minutes after admission to the post-anesthetic care unit

Full Information

First Posted
July 22, 2015
Last Updated
August 5, 2015
Sponsor
Michael Garron Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02518815
Brief Title
Preoperative Warming Prevents Postoperative Hypothermia in Laparoscopic Gynecologic Surgery. A Randomized Control Trial
Official Title
Preoperative Active Warming Prevents Postoperative Hypothermia in Patients Undergoing Laparoscopic Gynecologic Surgery. A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Michael Garron Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study examined whether 20 minutes of prewarming prior to gynecological laparoscopic surgery prevented inadvertent post-operative hypothermia. Treatment group received prewarming using a forced air body warming, control group received no active warming system. Both groups were then warmed with forced air warmer intraoperatively.
Detailed Description
Inadvertent perioperative hypothermia is a well known perioperative complication. The behavioural response to hypothermia is the most powerful protective tool, more effective than any autonomic response, and is obviously removed in the operative setting. Anesthesia alters thermoregulation by profoundly changing the thresholds for vasoconstriction and shivering, making patients vulnerable to the adverse outcomes related to mild hypothermia. Inadvertent postoperative hypothermia can occur in up to 70% of surgical patients. It is defined as a core temperature below 36°C (96.8°F). The aim of this study was to determine if prewarming with an active warming system for 20 minutes preoperatively could prevent postoperative inadvertent hypothermia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia Following Anesthesia, Hypothermia, Hypothermia, Accidental, Body Temperature Changes, Hypothermia Due to Anesthetic

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prewarming group
Arm Type
Experimental
Arm Description
Prewarmed for 20 minutes prior to OR using 3M Bair Paws System, a forced air warming blanket. This warming blanket was then used intraoperatively throughout the case.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients received standard care, which is no active prewarming prior to OR. A full body, forced air warming blanket (same as treatment group) was used intraoperatively throughout the case.
Intervention Type
Device
Intervention Name(s)
3M Bair Paws Warming System
Intervention Description
20 minutes of prewarming immediately pre-operatively using 3M Bair Paws warming system
Primary Outcome Measure Information:
Title
Oral temperature immediately postoperatively
Description
Immediate postoperative oral temperature on admission to the post-anesthetic care unit.
Time Frame
Immediately post-operatively
Secondary Outcome Measure Information:
Title
Oral temperature 30 minutes postoperatively
Description
Oral temperature 30 minutes after admission to the post-anesthetic care unit.
Time Frame
30 min after admission to post-anesthetic care unit
Title
Oral temperature at discharge from post-anesthetic care unit
Description
Oral temperature upon discharge from the post-anesthetic care unit.
Time Frame
Discharge from post-anesthetic care unit (average 99 minutes)
Title
11-point Pain score
Description
11-point VAS pain score postoperatively measured 30 minutes after admission to the post-anesthetic care unit
Time Frame
30 min after admission to post-anesthetic care unit

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA I-III undergoing elective laparoscopic gynecological surgical procedures expected duration >60 minutes BMI 18-45 Exclusion Criteria: Current fever (temperature>38.1°C) active endocrine disorders were exclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Kulchyk, MD
Organizational Affiliation
Michael Garron Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto East General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4C 3E7
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
17265749
Citation
Bellamy C. Inadvertent hypothermia in the operating theatre: an examination. J Perioper Pract. 2007 Jan;17(1):18-25. doi: 10.1177/175045890701700102.
Results Reference
background
PubMed Identifier
19137807
Citation
Kurz A. Physiology of thermoregulation. Best Pract Res Clin Anaesthesiol. 2008 Dec;22(4):627-44. doi: 10.1016/j.bpa.2008.06.004.
Results Reference
background
PubMed Identifier
8533913
Citation
Annadata R, Sessler DI, Tayefeh F, Kurz A, Dechert M. Desflurane slightly increases the sweating threshold but produces marked, nonlinear decreases in the vasoconstriction and shivering thresholds. Anesthesiology. 1995 Dec;83(6):1205-11. doi: 10.1097/00000542-199512000-00011.
Results Reference
background
PubMed Identifier
7631951
Citation
Kurz A, Go JC, Sessler DI, Kaer K, Larson MD, Bjorksten AR. Alfentanil slightly increases the sweating threshold and markedly reduces the vasoconstriction and shivering thresholds. Anesthesiology. 1995 Aug;83(2):293-9. doi: 10.1097/00000542-199508000-00009.
Results Reference
background
PubMed Identifier
7741292
Citation
Matsukawa T, Kurz A, Sessler DI, Bjorksten AR, Merrifield B, Cheng C. Propofol linearly reduces the vasoconstriction and shivering thresholds. Anesthesiology. 1995 May;82(5):1169-80. doi: 10.1097/00000542-199505000-00012.
Results Reference
background
PubMed Identifier
9357885
Citation
Talke P, Tayefeh F, Sessler DI, Jeffrey R, Noursalehi M, Richardson C. Dexmedetomidine does not alter the sweating threshold, but comparably and linearly decreases the vasoconstriction and shivering thresholds. Anesthesiology. 1997 Oct;87(4):835-41. doi: 10.1097/00000542-199710000-00017.
Results Reference
background
PubMed Identifier
9100967
Citation
Sessler DI. Perioperative thermoregulation and heat balance. Ann N Y Acad Sci. 1997 Mar 15;813:757-77. doi: 10.1111/j.1749-6632.1997.tb51779.x.
Results Reference
background
PubMed Identifier
10844839
Citation
Buggy DJ, Crossley AW. Thermoregulation, mild perioperative hypothermia and postanaesthetic shivering. Br J Anaesth. 2000 May;84(5):615-28. doi: 10.1093/bja/84.5.615. No abstract available.
Results Reference
background
PubMed Identifier
14661656
Citation
Doufas AG. Consequences of inadvertent perioperative hypothermia. Best Pract Res Clin Anaesthesiol. 2003 Dec;17(4):535-49. doi: 10.1016/s1521-6896(03)00052-1.
Results Reference
background
PubMed Identifier
19137808
Citation
Reynolds L, Beckmann J, Kurz A. Perioperative complications of hypothermia. Best Pract Res Clin Anaesthesiol. 2008 Dec;22(4):645-57. doi: 10.1016/j.bpa.2008.07.005.
Results Reference
background
PubMed Identifier
8606715
Citation
Kurz A, Sessler DI, Lenhardt R. Perioperative normothermia to reduce the incidence of surgical-wound infection and shorten hospitalization. Study of Wound Infection and Temperature Group. N Engl J Med. 1996 May 9;334(19):1209-15. doi: 10.1056/NEJM199605093341901.
Results Reference
background
PubMed Identifier
7879936
Citation
Sessler DI, Schroeder M, Merrifield B, Matsukawa T, Cheng C. Optimal duration and temperature of prewarming. Anesthesiology. 1995 Mar;82(3):674-81. doi: 10.1097/00000542-199503000-00009.
Results Reference
background
PubMed Identifier
12719051
Citation
Vanni SM, Braz JR, Modolo NS, Amorim RB, Rodrigues GR Jr. Preoperative combined with intraoperative skin-surface warming avoids hypothermia caused by general anesthesia and surgery. J Clin Anesth. 2003 Mar;15(2):119-25. doi: 10.1016/s0952-8180(02)00512-3.
Results Reference
background
PubMed Identifier
22037543
Citation
Hocker J, Bein B, Bohm R, Steinfath M, Scholz J, Horn EP. Correlation, accuracy, precision and practicability of perioperative measurement of sublingual temperature in comparison with tympanic membrane temperature in awake and anaesthetised patients. Eur J Anaesthesiol. 2012 Feb;29(2):70-4. doi: 10.1097/EJA.0b013e32834cd6de.
Results Reference
background
PubMed Identifier
10208200
Citation
Amoateng-Adjepong Y, Del Mundo J, Manthous CA. Accuracy of an infrared tympanic thermometer. Chest. 1999 Apr;115(4):1002-5. doi: 10.1378/chest.115.4.1002.
Results Reference
background
PubMed Identifier
9087467
Citation
Frank SM, Fleisher LA, Breslow MJ, Higgins MS, Olson KF, Kelly S, Beattie C. Perioperative maintenance of normothermia reduces the incidence of morbid cardiac events. A randomized clinical trial. JAMA. 1997 Apr 9;277(14):1127-34.
Results Reference
background
PubMed Identifier
11567703
Citation
Melling AC, Ali B, Scott EM, Leaper DJ. Effects of preoperative warming on the incidence of wound infection after clean surgery: a randomised controlled trial. Lancet. 2001 Sep 15;358(9285):876-80. doi: 10.1016/S0140-6736(01)06071-8. Erratum In: Lancet 2002 Mar 9;359(9309):896.
Results Reference
background
PubMed Identifier
8569362
Citation
Schmied H, Kurz A, Sessler DI, Kozek S, Reiter A. Mild hypothermia increases blood loss and transfusion requirements during total hip arthroplasty. Lancet. 1996 Feb 3;347(8997):289-92. doi: 10.1016/s0140-6736(96)90466-3.
Results Reference
background
PubMed Identifier
11004060
Citation
Winkler M, Akca O, Birkenberg B, Hetz H, Scheck T, Arkilic CF, Kabon B, Marker E, Grubl A, Czepan R, Greher M, Goll V, Gottsauner-Wolf F, Kurz A, Sessler DI. Aggressive warming reduces blood loss during hip arthroplasty. Anesth Analg. 2000 Oct;91(4):978-84. doi: 10.1097/00000539-200010000-00039.
Results Reference
background
PubMed Identifier
22376088
Citation
Horn EP, Bein B, Bohm R, Steinfath M, Sahili N, Hocker J. The effect of short time periods of pre-operative warming in the prevention of peri-operative hypothermia. Anaesthesia. 2012 Jun;67(6):612-7. doi: 10.1111/j.1365-2044.2012.07073.x. Epub 2012 Feb 29.
Results Reference
background
PubMed Identifier
10036122
Citation
Ott DE, Reich H, Love B, McCorvey R, Toledo A, Liu CY, Syed R, Kumar K. Reduction of laparoscopic-induced hypothermia, postoperative pain and recovery room length of stay by pre-conditioning gas with the Insuflow device: a prospective randomized controlled multi-center study. JSLS. 1998 Oct-Dec;2(4):321-9.
Results Reference
background
PubMed Identifier
9241334
Citation
Makinen MT. Comparison of body temperature changes during laparoscopic and open cholecystectomy. Acta Anaesthesiol Scand. 1997 Jun;41(6):736-40. doi: 10.1111/j.1399-6576.1997.tb04775.x.
Results Reference
background
PubMed Identifier
10227947
Citation
Luck AJ, Moyes D, Maddern GJ, Hewett PJ. Core temperature changes during open and laparoscopic colorectal surgery. Surg Endosc. 1999 May;13(5):480-3. doi: 10.1007/s004649901017.
Results Reference
background
PubMed Identifier
18639246
Citation
Peng Y, Zheng M, Ye Q, Chen X, Yu B, Liu B. Heated and humidified CO2 prevents hypothermia, peritoneal injury, and intra-abdominal adhesions during prolonged laparoscopic insufflations. J Surg Res. 2009 Jan;151(1):40-7. doi: 10.1016/j.jss.2008.03.039. Epub 2008 Apr 23.
Results Reference
background
PubMed Identifier
10593458
Citation
Nelskyla K, Yli-Hankala A, Sjoberg J, Korhonen I, Korttila K. Warming of insufflation gas during laparoscopic hysterectomy: effect on body temperature and the autonomic nervous system. Acta Anaesthesiol Scand. 1999 Nov;43(10):974-8. doi: 10.1034/j.1399-6576.1999.431002.x.
Results Reference
background
PubMed Identifier
23088746
Citation
Fernandes LA, Braz LG, Koga FA, Kakuda CM, Modolo NS, de Carvalho LR, Vianna PT, Braz JR. Comparison of peri-operative core temperature in obese and non-obese patients. Anaesthesia. 2012 Dec;67(12):1364-9. doi: 10.1111/anae.12002.x. Epub 2012 Oct 22.
Results Reference
background
PubMed Identifier
11594097
Citation
Nguyen NT, Fleming NW, Singh A, Lee SJ, Goldman CD, Wolfe BM. Evaluation of core temperature during laparoscopic and open gastric bypass. Obes Surg. 2001 Oct;11(5):570-5. doi: 10.1381/09608920160557039.
Results Reference
background
PubMed Identifier
20042439
Citation
De Witte JL, Demeyer C, Vandemaele E. Resistive-heating or forced-air warming for the prevention of redistribution hypothermia. Anesth Analg. 2010 Mar 1;110(3):829-33. doi: 10.1213/ANE.0b013e3181cb3ebf. Epub 2009 Dec 30.
Results Reference
background

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Preoperative Warming Prevents Postoperative Hypothermia in Laparoscopic Gynecologic Surgery. A Randomized Control Trial

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