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

This study has been completed.
Sponsor:
Information provided by:
Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT00651898
First received: March 31, 2008
Last updated: February 16, 2011
Last verified: February 2011
History of Changes
  Purpose

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
Abdominal Surgery
Hypothermia

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Outcomes Research Consortium:

Primary Outcome Measures:
  • The primary outcome will comprise the difference between the pre-induction temperature and the intraoperative temperature [ Time Frame: Every 15 minutes throughout surgery ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: August 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00651898

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Outcomes Research Consortium
Investigators
Principal Investigator: Maged Argalious, MD The Cleveland Clinic
Study Chair: Daniel I Sessler, MD The Cleveland Clinic
  More Information

No publications provided by Outcomes Research Consortium

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Maged Argalious, MD, Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00651898     History of Changes
Other Study ID Numbers: 06-597
Study First Received: March 31, 2008
Last Updated: February 16, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Outcomes Research Consortium:
abdominal surgery
hypothermia
circulating water mattress

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013