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NCT03824262 Clinical Trial

The Comparison of Warming Techniques in Patients Undergoing Open Abdominal Surgery in Litotomy Position

Temperature Change, Body Clinical Trial

Official title:
The Comparison of Warming Techniques in Patients Undergoing Open Abdominal Surgery in Litotomy Position

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03824262
Other study ID # E.308215
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 4, 2019
Est. completion date May 4, 2019

Study information
Verified date May 2019
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The patients scheduled to undergo major abdominal surgery in litotomy position will be randomized into two groups in order to compare the effects of two warming techniques during the intraoperative period.

Description:

The patients will be randomized into two groups. All patients will receive prewarming with forced-air warming device for 30 minutes. All patients will receive warmed fluids during intraoperative period. One group will receive warming with only forced-air warming device and the other group will receive warming with both forced-air warming device and water mattress. Timpanic, esophageal and peripheral temperature monitoring will be performed.

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date May 4, 2019
Est. primary completion date May 4, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Major abdominal surgery in litotomy position

- ASA I-II

- Anticipated operation time over 1 hour

Exclusion Criteria:

- Sepsis

- Hypothermia

- Hyperthermia

- Malignant Hyperthermia

- Tyroid dysfunction

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• HICO-VARIOTHERM 550
Warming during perioperative period.
• Mistral-Air Plus forced air warming device
Warming during perioperative period.

Locations
Country Name City State
Turkey Hacettepe University School of Medicine Hospital Ankara

Sponsors (1)
Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Body temperature-esophageal probe Esophageal probe used to measure core body temperature Perioperative period-every 15 minutes
Secondary Body temperature-tympanic thermometer Tympanic thermometer used to measure body temperature Perioperative period-every 15 minutes
Secondary Body temperature-skin thermometer Skin thermometer used to measure body temperature Perioperative period-every 15 minutes
Secondary Duration of operation Duration of operation compared with the change in body temperature Perioperative period
Secondary Blood loss Blood loss during the perioperative period Perioperative period
Secondary Shivering after the operation Assessment of shivering after operation in the recovery room with PAS score Postoperative 1st hour every 10 minutes
Secondary Time to extubation Time to extubation at the end of operation The end of the operation
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