The Comparison of Warming Techniques in Patients Undergoing Open Abdominal Surgery in Litotomy Position
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hacettepe University
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Body temperature-esophageal probe
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Major abdominal surgery in litotomy position
- •Anticipated operation time over 1 hour
Exclusion Criteria
- •Hypothermia
- •Hyperthermia
- •Malignant Hyperthermia
- •Tyroid dysfunction
Arms & Interventions
Group I
HICO-VARIOTHERM 550 and Mistral-Air Plus forced-air warming device
Intervention: HICO-VARIOTHERM 550 (Device)
Group I
HICO-VARIOTHERM 550 and Mistral-Air Plus forced-air warming device
Intervention: Mistral-Air Plus forced air warming device (Device)
Group II
Mistral-Air Plus forced-air warming device
Intervention: Mistral-Air Plus forced air warming device (Device)
Outcomes
Primary Outcomes
Body temperature-esophageal probe
Time Frame: Perioperative period-every 15 minutes
Esophageal probe used to measure core body temperature
Secondary Outcomes
- Body temperature-skin thermometer(Perioperative period-every 15 minutes)
- Body temperature-tympanic thermometer(Perioperative period-every 15 minutes)
- Duration of operation(Perioperative period)
- Time to extubation(The end of the operation)
- Blood loss(Perioperative period)
- Shivering after the operation(Postoperative 1st hour every 10 minutes)
Investigators
Filiz Uzumcugil
Principal Investigator, MD, Asist. Prof.
Hacettepe University