Circulating-water Garment With Forced-air Warming and Circulating-water Mattress During Abdominal Surgery

Hypothermia Clinical Trial

Official title:

Comparison of a Circulating-water Garment With a Combination of Forced-air Warming and Circulating-water Mattress Warming During Major Abdominal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00651898
• Other study ID #: 06-597
• Status: Completed
• Phase: N/A
• First received: March 31, 2008
• Last updated: February 27, 2016
• Start date: August 2006
• Est. completion date: June 2008

Study information

• Verified date: February 2016
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to see if the combination of a circulating water mattress beneath the patient combined with forced air warming over top of the patient will prevent hypothermia (low body temperature) just as well as a garment that circulates warm water around the patient, during your major abdominal surgery. Patients will be randomly assigned to one of these two groups.

Description:

Group A: This group will receive the circulating water garment Group B: This group will receive the circulating water mattress and be covered by a forced air warming device for both the upper body and lower body

Once the patient is moved to the operating room table, the surface of the back will begin to be warmed using either the circulating-water garment for those in Group A or the circulating-water mattress for those in Group B. Following the start of anesthesia, additional warming will be done by covering the large parts of the legs and the upper and side of the chest using either the circulating-water garment for those in Group A or upper- and lower-body forced-air warmers for those in Group B.

Patient involvement will last until the warming devices are removed prior to departure from the operating room. There is no follow-up to this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• MaJor abdominal surgery

• Age between 18 and 85 years.

Exclusion Criteria:

• Fever (core temperature >38°C)

• Combined procedures (e.g.: simultaneous liver and kidney transplantation)

• Contraindication to forced-air or circulating-water warming which would be impacted by use of warming blanket

• Anticipated veno-venous bypass

• Current Pregnancy

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Hypothermia

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome will comprise the difference between the pre-induction temperature and the intraoperative temperature		Every 15 minutes throughout surgery	No