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

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.

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

Conditions
-----------------
Temperature Change, Body

Intervention / Treatment
-----------------
* Device: HICO-VARIOTHERM 550
* Device: Mistral-Air Plus forced air warming device


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I<br>HICO-VARIOTHERM 550 and Mistral-Air Plus forced-air warming device | Device: HICO-VARIOTHERM 550<br>* Warming during perioperative period.<br>Device: Mistral-Air Plus forced air warming device<br>* Warming during perioperative period.<br>|
| Active Comparator: Group II<br>Mistral-Air Plus forced-air warming device | Device: Mistral-Air Plus forced air warming device<br>* Warming during perioperative period.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body temperature-esophageal probe | Esophageal probe used to measure core body temperature | Perioperative period-every 15 minutes | 

Secondary Outcome Measures

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