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| Sponsored by: |
Outcomes Research Consortium |
|---|---|
| Information provided by: | Outcomes Research Consortium |
| ClinicalTrials.gov Identifier: | NCT00651898 |
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: | 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 |
| 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
|
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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.
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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 |
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
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Ohio | |
| Cleveland Clinic | |
| Cleveland, Ohio, United States, 44195 | |
| Principal Investigator: | Maged Argalious, MD | Cleveland Clinic |
| Study Chair: | Daniel I Sessler, MD | Cleveland Clinic |
More Information
| Responsible Party: | Cleveland Clinic ( Maged Argalious, MD ) |
| Study ID Numbers: | 06-597 |
| Study First Received: | March 31, 2008 |
| Last Updated: | June 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00651898 |
| Health Authority: | United States: Institutional Review Board |
|
abdominal surgery hypothermia circulating water mattress |
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Signs and Symptoms Hypothermia |
|
Body Temperature Changes |
