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

NCT ID: NCT00651898

Last Updated: 2016-03-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2008-06-30

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.

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.

Conditions

Hypothermia

Study Design

• Observational Model Type: COHORT

Study Groups

A

This group will receive the circulating water garment

No interventions assigned to this 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 connected to two warmers.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

d sessler

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maged Argalious, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Daniel I Sessler, MD

Role: STUDY_CHAIR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

References

Perez-Protto S, Sessler DI, Reynolds LF, Bakri MH, Mascha E, Cywinski J, Parker B, Argalious M. Circulating-water garment or the combination of a circulating-water mattress and forced-air cover to maintain core temperature during major upper-abdominal surgery. Br J Anaesth. 2010 Oct;105(4):466-70. doi: 10.1093/bja/aeq170. Epub 2010 Aug 3.

Reference Type: DERIVED

PMID: 20685683 (View on PubMed)

Other Identifiers

06-597

Identifier Type: -

Identifier Source: org_study_id