Hypothermia Following AnesthesiaNCT02518815
Preoperative Warming Prevents Postoperative Hypothermia in Laparoscopic Gynecologic Surgery. A Randomized Control Trial
A study testing 3M Bair Paws Warming System in people with Hypothermia Following Anesthesia and Hypothermia, run by Michael Garron Hospital at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Hypothermia Following Anesthesia, Hypothermia, Hypothermia, Accidental
- What is being tested?
- 3M Bair Paws Warming System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- May 2013to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ASA I-III
- undergoing elective laparoscopic gynecological surgical procedures
- expected duration >60 minutes
- BMI 18-45
Who cannot join
- Current fever (temperature>38.1°C)
- active endocrine disorders were exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Active Warming Prevents Postoperative Hypothermia in Patients Undergoing Laparoscopic Gynecologic Surgery. A Randomized Control Trial
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.
Read the 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.
- Conditions
- Hypothermia Following Anesthesia, Hypothermia, Hypothermia, Accidental, Body Temperature Changes, Hypothermia Due to Anesthetic
- Being tested
- 3M Bair Paws Warming System
- Medical subject headings
- Hypothermia, Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3M Bair Paws Warming SystemDevice
20 minutes of prewarming immediately pre-operatively using 3M Bair Paws warming system
| Study group | Role | What they receive |
|---|---|---|
| Prewarming group | Experimental | 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. Receives: Device: 3M Bair Paws Warming System |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral temperature immediately postoperatively
Immediate postoperative oral temperature on admission to the post-anesthetic care unit.
Measured: Immediately post-operatively
Secondary outcomes (3)
Oral temperature 30 minutes postoperatively
Oral temperature 30 minutes after admission to the post-anesthetic care unit.
Measured: 30 min after admission to post-anesthetic care unit
Oral temperature at discharge from post-anesthetic care unit
Oral temperature upon discharge from the post-anesthetic care unit.
Measured: Discharge from post-anesthetic care unit (average 99 minutes)
11-point Pain score
11-point VAS pain score postoperatively measured 30 minutes after admission to the post-anesthetic care unit
Measured: 30 min after admission to post-anesthetic care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2015 (estimated)
- Study startMay 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Hypothermia Following AnesthesiaStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Garron Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Kulchyk, MD, Principal investigator, Michael Garron Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518815
- Sponsor's protocol ID
- 550-1304-Mis-213
- Status last verified
- Aug 2015
- First submitted
- 22 Jul 2015
- Last updated
- 10 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bellamy C. Inadvertent hypothermia in the operating theatre: an examination. J Perioper Pract. 2007 Jan;17(1):18-25. doi: 10.1177/175045890701700102.
PubMed 17265749Kurz A. Physiology of thermoregulation. Best Pract Res Clin Anaesthesiol. 2008 Dec;22(4):627-44. doi: 10.1016/j.bpa.2008.06.004.
PubMed 19137807Annadata 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.
PubMed 8533913Kurz 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.
PubMed 7631951Matsukawa 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.
PubMed 7741292Talke 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.
PubMed 9357885Sessler 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.
PubMed 9100967Buggy 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.
PubMed 10844839Doufas 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.
PubMed 14661656Reynolds 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.
PubMed 19137808Kurz 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 8606715Sessler 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.
PubMed 7879936Vanni 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.
PubMed 12719051Hocker 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.
PubMed 22037543Amoateng-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.
PubMed 10208200
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Active Warming Prevents Postoperative Hypothermia in Patients Undergoing Laparoscopic Gynecologic Surgery. A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02518815
- Acronym / sponsor ID
- 550-1304-Mis-213
- Conditions
- Hypothermia Following Anesthesia, Hypothermia, Hypothermia, Accidental, Body Temperature Changes, Hypothermia Due to Anesthetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Michael Garron HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 10 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prewarming group | Experimental | Device: 3M Bair Paws Warming SystemPrewarmed 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- ASA I-III
- undergoing elective laparoscopic gynecological surgical procedures
- expected duration >60 minutes
- BMI 18-45
Key exclusion criteria (2 listed)
- Current fever (temperature>38.1°C)
- active endocrine disorders were exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3M Bair Paws Warming System20 minutes of prewarming immediately pre-operatively using 3M Bair Paws warming system | Device | Prewarming group |
Primary outcome
Oral temperature immediately postoperatively
Time frame: Immediately post-operatively
Immediate postoperative oral temperature on admission to the post-anesthetic care unit.
3 secondary outcomes
Oral temperature 30 minutes postoperatively
Time frame: 30 min after admission to post-anesthetic care unit
Oral temperature at discharge from post-anesthetic care unit
Time frame: Discharge from post-anesthetic care unit (average 99 minutes)
11-point Pain score
Time frame: 30 min after admission to post-anesthetic care unit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2015.
- Background: PubMed 17265749Bellamy C. Inadvertent hypothermia in the operating theatre: an examination. J Perioper Pract. 2007 Jan;17(1):18-25. doi: 10.1177/175045890701700102.
- Background: PubMed 19137807Kurz A. Physiology of thermoregulation. Best Pract Res Clin Anaesthesiol. 2008 Dec;22(4):627-44. doi: 10.1016/j.bpa.2008.06.004.
- Background: PubMed 8533913Annadata 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.
- Background: PubMed 7631951Kurz 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.
- Background: PubMed 7741292Matsukawa 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.
- Background: PubMed 9357885Talke 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.
- Background: PubMed 9100967Sessler 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.
- Background: PubMed 10844839Buggy 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.
- Background: PubMed 14661656Doufas 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.
- Background: PubMed 19137808Reynolds 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.
- Background: PubMed 8606715Kurz 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.
- Background: PubMed 7879936Sessler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Kulchyk, MD principal investigator
Michael Garron Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3M Bair Paws Warming System in people with Hypothermia Following Anesthesia and Hypothermia, run by Michael Garron Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral temperature immediately postoperatively (time frame: Immediately post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02518815, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2015.