Major Surgery Under General AnesthesiaNCT02715076
The Effects of Ambient Temperature and Forced-air Warming on Intraoperative Core Temperature
A study testing Ambient Temperature 19°C, Ambient Temperature 21°C and Ambient Temperature 23°C in people with Major Surgery Under General Anesthesia, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine: 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Major Surgery Under General Anesthesia
- What is being tested?
- Ambient Temperature 19°C, Ambient Temperature 21°C and Ambient Temperature 23°C
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Dec 2016
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Special risk for bleeding or myocardial infarction (as determined by the attending anesthesiologist)
- Patients who would otherwise have been actively warmed
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine:
- 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
- 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.
Read the detailed description
Each patient will be randomly assigned to ambient temperature of 19°C, 21°C, or 23°C. Using a factorial approach, patients will also be randomly assigned to passive insulation or forced-air warming, stratified by the three types of surgery listed below. Group allocation will be based on computer generated codes (randomly permuted block sizes) prepared by Department of OUTCOMES RESEARCH statisticians using SAS statistical software. Allocation of consented patients to designated ambient temperature and forced-air vs. passive insulation will be via a web site that will be accessed by investigators in Bejing about 90 minutes before surgery.
Patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping. 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. A lower-body cover (about 91 by 221 cm) will be positioned so the lower end of the forced-air segments extend from the ankles upward for the entire length of the cover in thoracic and abdominal cases. The cover's foot drape will extend over the feet, and in turn be covered by the surgical drape. An upper-body forced-air cover will similarly be applied for patients having hip arthroplasties. The forced-air cover will be connected to a Bair Hugger blower and #635 covers set to "high" (≈43°C).
Ambient temperature will be adjusted to the designated temperature about an hour before a patient enters the operating room and adjusted as necessary to maintain the designated temperature throughout surgery. General anesthesia will be induced as per usual clinical routine. Neuraxial (epidural or spinal) and other regional blocks are permitted.
Any patients whose core temperature decreases to less than 34.5°C will be actively warmed with forced air and the ambient temperature increases to the extent practical.
- Conditions
- Major Surgery Under General Anesthesia
- Being tested
- Ambient Temperature 19°C, Ambient Temperature 21°C, Ambient Temperature 23°C, Forced-air cover (Bair hugger 63500, 3M), Passive insulation
- Keywords
- Thoracic Surgery, Thoracic surgery, Video assisted, Open Abdominal Surgery, Anesthesia, General
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambient Temperature 19°COther
Ambient Temperature 19°C
Ambient Temperature 21°COther
Ambient Temperature 21°C
Ambient Temperature 23°COther
Ambient Temperature 23°C
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.
Passive insulationOther
Patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Ambient Temperature 23°C; Device: Forced-air cover (Bair hugger 63500, 3M) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from 1 to 3 hours after induction of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Major Surgery Under General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Clinic
- Responsible party
- Principal investigator, Lijian Pei, Peking Union Medical College Hospital
- Investigators
- LiJian Pei, MD, Principal investigator, Associate Prof. of Dept. of Anesthesiology, PUMCHYuguang Huang, MD, Study chair, Chair of Dept. of Anesthesiology, PUMCHDaniel I Sessler, MD, Study director, Chair of Dept. of Outcomes Research, Anesthesiology Institute, Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02715076
- Sponsor's protocol ID
- ZS-878
- Status last verified
- Apr 2021
- First submitted
- 29 Feb 2016
- Last updated
- 11 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 1610573Rajagopalan 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.
PubMed 18156884Kurz 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.
PubMed 8606715Lenhardt 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.
PubMed 9416715Kurz 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.
PubMed 7576669Matsukawa 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.
PubMed 7486181Matsukawa 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.
PubMed 7879935Hynson 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.
PubMed 8342834Camus 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.
PubMed 7576673Kurz 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.
PubMed 7661349Roe 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.
PubMed 5091847Rajek 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.
PubMed 10969294Sessler 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.
PubMed 1990897Sessler DI, McGuire J, Sessler AM. Perioperative thermal insulation. Anesthesiology. 1991 May;74(5):875-9. doi: 10.1097/00000542-199105000-00012.
PubMed 2021204Sessler DI, Moayeri A. Skin-surface warming: heat flux and central temperature. Anesthesiology. 1990 Aug;73(2):218-24.
PubMed 2382847