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

Hypothermia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02518815
• Other study ID #: 550-1304-Mis-213
• Status: Completed
• Phase: N/A
• First received: July 22, 2015
• Last updated: August 5, 2015
• Start date: May 2013
• Est. completion date: January 2014

Study information

• Verified date: August 2015
• Source: Toronto East General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Body Temperature Changes
• Hypothermia
• Hypothermia Due to Anesthetic
• Hypothermia Following Anesthesia
• Hypothermia, Accidental

Intervention

Device:
• 3M Bair Paws Warming System
20 minutes of prewarming immediately pre-operatively using 3M Bair Paws warming system

Locations

Country	Name	City	State
Canada	Toronto East General Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Toronto East General Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (28)

Amoateng-Adjepong Y, Del Mundo J, Manthous CA. Accuracy of an infrared tympanic thermometer. Chest. 1999 Apr;115(4):1002-5. — View 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. — View Citation

Bellamy C. Inadvertent hypothermia in the operating theatre: an examination. J Perioper Pract. 2007 Jan;17(1):18-25. — View Citation

Buggy DJ, Crossley AW. Thermoregulation, mild perioperative hypothermia and postanaesthetic shivering. Br J Anaesth. 2000 May;84(5):615-28. Review. — View 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. — View Citation

Doufas AG. Consequences of inadvertent perioperative hypothermia. Best Pract Res Clin Anaesthesiol. 2003 Dec;17(4):535-49. Review. — View Citation

Fernandes LA, Braz LG, Koga FA, Kakuda CM, Módolo 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. — View 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. — View Citation

Höcker J, Bein B, Böhm 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. — View Citation

Horn EP, Bein B, Böhm R, Steinfath M, Sahili N, Höcker 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. — View 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. — View 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. — View Citation

Kurz A. Physiology of thermoregulation. Best Pract Res Clin Anaesthesiol. 2008 Dec;22(4):627-44. Review. — View 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. — View Citation

Mäkinen MT. Comparison of body temperature changes during laparoscopic and open cholecystectomy. Acta Anaesthesiol Scand. 1997 Jun;41(6):736-40. — View 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. — View 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. Erratum in: Lancet 2002 Mar 9;359(9309):896. — View Citation

Nelskylä K, Yli-Hankala A, Sjöberg 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. — View 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. — View 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. — View 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. — View Citation

Reynolds L, Beckmann J, Kurz A. Perioperative complications of hypothermia. Best Pract Res Clin Anaesthesiol. 2008 Dec;22(4):645-57. Review. — View 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. — View Citation

Sessler DI, Schroeder M, Merrifield B, Matsukawa T, Cheng C. Optimal duration and temperature of prewarming. Anesthesiology. 1995 Mar;82(3):674-81. — View Citation

Sessler DI. Perioperative thermoregulation and heat balance. Ann N Y Acad Sci. 1997 Mar 15;813:757-77. Review. — View 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. — View Citation

Vanni SM, Braz JR, Módolo 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. — View Citation

Winkler M, Akça O, Birkenberg B, Hetz H, Scheck T, Arkiliç CF, Kabon B, Marker E, Grübl 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. — View Citation

* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral temperature immediately postoperatively	Immediate postoperative oral temperature on admission to the post-anesthetic care unit.	Immediately post-operatively	No
Secondary	Oral temperature 30 minutes postoperatively	Oral temperature 30 minutes after admission to the post-anesthetic care unit.	30 min after admission to post-anesthetic care unit	No
Secondary	Oral temperature at discharge from post-anesthetic care unit	Oral temperature upon discharge from the post-anesthetic care unit.	Discharge from post-anesthetic care unit (average 99 minutes)	No
Secondary	11-point Pain score	11-point VAS pain score postoperatively measured 30 minutes after admission to the post-anesthetic care unit	30 min after admission to post-anesthetic care unit	No