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

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.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Time frame: Every 15 minutes throughout surgery

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Apr 3, 2008
Registry last updated: Mar 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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