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

Sponsor

The Cleveland Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT00651898

Collaborator

(none)

Enrollment

Location

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hypothermia

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

50 participants

Observational Model:

Cohort

Official Title:

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

Study Start Date :

Aug 1, 2006

Actual Primary Completion Date :

Jun 1, 2008

Actual Study Completion Date :

Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
A This group will receive the circulating water garment
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 connected to two warmers.

Outcome Measures

Primary Outcome Measures

The primary outcome will comprise the difference between the pre-induction temperature and the intraoperative temperature [Every 15 minutes throughout surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

The Cleveland Clinic

Investigators

Principal Investigator: Maged Argalious, MD, The Cleveland Clinic
Study Chair: Daniel I Sessler, MD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

d sessler, MD, The Cleveland Clinic

ClinicalTrials.gov Identifier:

NCT00651898

Other Study ID Numbers:

06-597

First Posted:

Apr 3, 2008

Last Update Posted:

Mar 1, 2016

Last Verified:

Feb 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by d sessler, MD, The Cleveland Clinic

abdominal surgery

hypothermia

circulating water mattress

Additional relevant MeSH terms:

Hypothermia

Study Results

No Results Posted as of Mar 1, 2016