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

NCT00651898 | Completed

• 1 other identifier: 06-597
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypothermia

Keywords

abdominal surgery; hypothermia; circulating water mattress

Outcome Measures

Primary Outcomes (1)

• The primary outcome will comprise the difference between the pre-induction temperature and the intraoperative temperature

  Every 15 minutes throughout surgery

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male or female patients between 18-85 years of age who are undergoing major abdominal surgery who do not have a contradiction to forced-air or circulating water warming. Patient's undergoing combined procedures are not eligible to participate. Patient can not have a core temperature over 38°C, be pregnant or

You may qualify if:

• MaJor abdominal surgery
• Age between 18 and 85 years.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• 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.

  PMID: 20685683 DERIVED

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maged Argalious, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Daniel I Sessler, MD

  The Cleveland Clinic

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 31, 2008
• First Posted: April 3, 2008
• Study Start: August 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: March 1, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)