The Effects of Ambient Temperature and Forced-air Warming on Intraoperative Core Temperature

NCT02715076 | Completed Results

• 1 other identifier: ZS-878
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine:

1. 1.the effect of ambient temperature on the rate of core temperature change from 1 to 3 hours after induction of anesthesia (linear phase of the hypothermia curve) in major operations lasting at least a couple of hours and
2. 2.whether the relationship between ambient temperature and rate of core temperature change is different for patients who are or are not warmed with forced-air.

Conditions

Major Surgery Under General Anesthesia

Keywords

Thoracic Surgery; Thoracic surgery, Video assisted; Open Abdominal Surgery; Anesthesia, General

Outcome Measures

Primary Outcomes (1)

• Rate of Core Temperature Change

  Rate of core temperature change from 1 to 3 hours after induction of anesthesia (°C/hour ) linear mixed-effects model to assess the effects of ambient temperature, forced-air warming and their interaction on the rate of core temperature change during 1 to 3h after induction

  from 1 to 3 hours after induction of anesthesia

Study Arms (6)

Ambient Temp 19°C & Passive Insulation

EXPERIMENTAL

Ambient Temperature 19°C and Passive Insulation: patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping.

Other: Ambient Temperature 19°C; Other: Passive insulation

Ambient Temp 19°C & Forced-air Warming

EXPERIMENTAL

Ambient Temperature 19°C and Forced-air Warming: patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface.

Other: Ambient Temperature 19°C; Device: Forced-air cover (Bair hugger 63500, 3M)

Ambient Temp 21°C & Passive Insulation

EXPERIMENTAL

Ambient Temperature 21°C and Passive Insulation: patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping.

Other: Ambient Temperature 21°C; Other: Passive insulation

Ambient Temp 21°C & Forced-air Warming

EXPERIMENTAL

Ambient Temperature 21°C and Forced-air Warming: patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface.

Other: Ambient Temperature 21°C; Device: Forced-air cover (Bair hugger 63500, 3M)

Ambient Temp 23°C & Passive Insulation

EXPERIMENTAL

Ambient Temperature 23°C and Passive Insulation: patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping.

Other: Ambient Temperature 23°C; Other: Passive insulation

Ambient Temp 23°C & Forced-air Warming

EXPERIMENTAL

Ambient Temperature 23°C and Forced-air Warming: patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface.

Other: Ambient Temperature 23°C; Device: Forced-air cover (Bair hugger 63500, 3M)

Interventions

Ambient Temperature 19°C OTHER

Ambient Temperature 19°C

Ambient Temp 19°C & Forced-air Warming; Ambient Temp 19°C & Passive Insulation

Ambient Temperature 21°C OTHER

Ambient Temperature 21°C

Ambient Temp 21°C & Forced-air Warming; Ambient Temp 21°C & Passive Insulation

Ambient Temperature 23°C OTHER

Ambient Temperature 23°C

Ambient Temp 23°C & Forced-air Warming; Ambient Temp 23°C & Passive Insulation

Forced-air cover (Bair hugger 63500, 3M) DEVICE

Patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface.

Ambient Temp 19°C & Forced-air Warming; Ambient Temp 21°C & Forced-air Warming; Ambient Temp 23°C & Forced-air Warming

Passive insulation OTHER

Patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping.

Ambient Temp 19°C & Passive Insulation; Ambient Temp 21°C & Passive Insulation; Ambient Temp 23°C & Passive Insulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults scheduled for major open thoracic surgery or video assist thoracic surgery or major abdominal surgery under general anesthesia expected to last at least two hours

You may not qualify if:

• Special risk for bleeding or myocardial infarction (as determined by the attending anesthesiologist)
• Patients who would otherwise have been actively warmed

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• The Cleveland Clinic: collaborator

Study Sites (1)

Dept. of Anesthesiology, PUMCH

Beijing, 100730, China

Location

Related Publications (25)

• 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.

  PMID: 1610573 BACKGROUND

• Rajagopalan S, Mascha E, Na J, Sessler DI. The effects of mild perioperative hypothermia on blood loss and transfusion requirement. Anesthesiology. 2008 Jan;108(1):71-7. doi: 10.1097/01.anes.0000296719.73450.52.

  PMID: 18156884 BACKGROUND

• 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.

  PMID: 8606715 BACKGROUND

• Lenhardt R, Marker E, Goll V, Tschernich H, Kurz A, Sessler DI, Narzt E, Lackner F. Mild intraoperative hypothermia prolongs postanesthetic recovery. Anesthesiology. 1997 Dec;87(6):1318-23. doi: 10.1097/00000542-199712000-00009.

  PMID: 9416715 BACKGROUND

• Kurz A, Sessler DI, Narzt E, Bekar A, Lenhardt R, Huemer G, Lackner F. Postoperative hemodynamic and thermoregulatory consequences of intraoperative core hypothermia. J Clin Anesth. 1995 Aug;7(5):359-66. doi: 10.1016/0952-8180(95)00028-g.

  PMID: 7576669 BACKGROUND

• Matsukawa T, Sessler DI, Christensen R, Ozaki M, Schroeder M. Heat flow and distribution during epidural anesthesia. Anesthesiology. 1995 Nov;83(5):961-7. doi: 10.1097/00000542-199511000-00008.

  PMID: 7486181 BACKGROUND

• Matsukawa T, Sessler DI, Sessler AM, Schroeder M, Ozaki M, Kurz A, Cheng C. Heat flow and distribution during induction of general anesthesia. Anesthesiology. 1995 Mar;82(3):662-73. doi: 10.1097/00000542-199503000-00008.

  PMID: 7879935 BACKGROUND

• Hynson JM, Sessler DI, Moayeri A, McGuire J, Schroeder M. The effects of preinduction warming on temperature and blood pressure during propofol/nitrous oxide anesthesia. Anesthesiology. 1993 Aug;79(2):219-28, discussion 21A-22A. doi: 10.1097/00000542-199308000-00005.

  PMID: 8342834 BACKGROUND

• Camus Y, Delva E, Sessler DI, Lienhart A. Pre-induction skin-surface warming minimizes intraoperative core hypothermia. J Clin Anesth. 1995 Aug;7(5):384-8. doi: 10.1016/0952-8180(95)00051-i.

  PMID: 7576673 BACKGROUND

• Kurz A, Sessler DI, Christensen R, Dechert M. Heat balance and distribution during the core-temperature plateau in anesthetized humans. Anesthesiology. 1995 Sep;83(3):491-9. doi: 10.1097/00000542-199509000-00007.

  PMID: 7661349 BACKGROUND

• Roe CF. Effect of bowel exposure on body temperature during surgical operations. Am J Surg. 1971 Jul;122(1):13-5. doi: 10.1016/0002-9610(71)90338-2. No abstract available.

  PMID: 5091847 BACKGROUND

• Rajek A, Greif R, Sessler DI, Baumgardner J, Laciny S, Bastanmehr H. Core cooling by central venous infusion of ice-cold (4 degrees C and 20 degrees C) fluid: isolation of core and peripheral thermal compartments. Anesthesiology. 2000 Sep;93(3):629-37. doi: 10.1097/00000542-200009000-00010.

  PMID: 10969294 BACKGROUND

• Sessler DI, McGuire J, Moayeri A, Hynson J. Isoflurane-induced vasodilation minimally increases cutaneous heat loss. Anesthesiology. 1991 Feb;74(2):226-32. doi: 10.1097/00000542-199102000-00006.

  PMID: 1990897 BACKGROUND

• Sessler DI, McGuire J, Sessler AM. Perioperative thermal insulation. Anesthesiology. 1991 May;74(5):875-9. doi: 10.1097/00000542-199105000-00012.

  PMID: 2021204 BACKGROUND

• Sessler DI, Moayeri A. Skin-surface warming: heat flux and central temperature. Anesthesiology. 1990 Aug;73(2):218-24.

  PMID: 2382847 BACKGROUND

• Giesbrecht GG, Ducharme MB, McGuire JP. Comparison of forced-air patient warming systems for perioperative use. Anesthesiology. 1994 Mar;80(3):671-9. doi: 10.1097/00000542-199403000-00026.

  PMID: 8141463 BACKGROUND

• Morris RH. Influence of ambient temperature on patient temperature during intraabdominal surgery. Ann Surg. 1971 Feb;173(2):230-3. doi: 10.1097/00000658-197102000-00008. No abstract available.

  PMID: 5100096 BACKGROUND

• Morris RH. Operating room temperature and the anesthetized, paralyzed patient. Arch Surg. 1971 Feb;102(2):95-7. doi: 10.1001/archsurg.1971.01350020005002. No abstract available.

  PMID: 4250862 BACKGROUND

• Morris RH, Wilkey BR. The effects of ambient temperature on patient temperature during surgery not involving body cavities. Anesthesiology. 1970 Feb;32(2):102-7. doi: 10.1097/00000542-197002000-00003. No abstract available.

  PMID: 5414287 BACKGROUND

• Wang CS, Chen CL, Huang CJ, Cheng KW, Chen KH, Wang CC, Concejero AM, Cheng YF, Huang TL, Wang SH, Lin CC, Liu YW, Yong CC, Yang CH, Jawan B. Effects of different operating room temperatures on the body temperature undergoing live liver donor hepatectomy. Transplant Proc. 2008 Oct;40(8):2463-5. doi: 10.1016/j.transproceed.2008.07.077.

  PMID: 18929769 BACKGROUND

• Tander B, Baris S, Karakaya D, Ariturk E, Rizalar R, Bernay F. Risk factors influencing inadvertent hypothermia in infants and neonates during anesthesia. Paediatr Anaesth. 2005 Jul;15(7):574-9. doi: 10.1111/j.1460-9592.2005.01504.x.

  PMID: 15960641 BACKGROUND

• Ozer AB, Tosun F, Demirel I, Unlu S, Bayar MK, Erhan OL. The effects of anesthetic technique and ambient temperature on thermoregulation in lower extremity surgery. J Anesth. 2013 Aug;27(4):528-34. doi: 10.1007/s00540-013-1555-2. Epub 2013 Jan 23.

  PMID: 23340983 BACKGROUND

• Cheng KW, Wang CH, Chen CL, Jawan B, Wang CC, Concejero AM, Wang SH, Liu YW, Yong CC, Yang CH, Huang CJ. Decreased fresh gas flow cannot compensate for an increased operating room temperature in maintaining body temperature during donor hepatectomy for living liver donor hepatectomy. Transplant Proc. 2010 Apr;42(3):703-4. doi: 10.1016/j.transproceed.2010.02.065.

  PMID: 20430151 BACKGROUND

• Frank SM, Beattie C, Christopherson R, Norris EJ, Rock P, Parker S, Kimball AW Jr. Epidural versus general anesthesia, ambient operating room temperature, and patient age as predictors of inadvertent hypothermia. Anesthesiology. 1992 Aug;77(2):252-7. doi: 10.1097/00000542-199208000-00005.

  PMID: 1642343 BACKGROUND

• Sun C, Gao H, Zhang Y, Pei L, Huang Y. Risk Stratification for Organ/Space Surgical Site Infection in Advanced Digestive System Cancer. Front Oncol. 2021 Nov 9;11:705335. doi: 10.3389/fonc.2021.705335. eCollection 2021.

  PMID: 34858805 DERIVED

Results Point of Contact

• Title: Dr. Daniel I. Sessler
• Organization: Department of outcomes research Cleveland Ohio

ds@or.org

Study Officials

• LiJian Pei, MD

  Associate Prof. of Dept. of Anesthesiology, PUMCH

  PRINCIPAL INVESTIGATOR

• Yuguang Huang, MD

  Chair of Dept. of Anesthesiology, PUMCH

  STUDY CHAIR

• Daniel I Sessler, MD

  Chair of Dept. of Outcomes Research, Anesthesiology Institute, Cleveland Clinic

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 29, 2016
• First Posted: March 22, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 11, 2021
• Results First Posted: April 6, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)