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

Not Applicable

Completed

• Conditions: Temperature Change, Body
• Interventions: Device: HICO-VARIOTHERM 550; Device: Mistral-Air Plus forced air warming device

• Registration Number: NCT03824262
• Lead Sponsor: Hacettepe University

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 Timeline

• Study First Submitted: 2019-01-29
• Study First Submitted QC: 2019-01-29
• Study First Posted: 2019-01-31
• Study Start: 2019-02-04
• Status Verified: 2019-05
• Primary Completion: 2019-05-04
• Study Completion: 2019-05-04
• Last Update Submitted: 2019-05-04
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I	HICO-VARIOTHERM 550	HICO-VARIOTHERM 550 and Mistral-Air Plus forced-air warming device
Group I	Mistral-Air Plus forced air warming device	HICO-VARIOTHERM 550 and Mistral-Air Plus forced-air warming device
Group II	Mistral-Air Plus forced air warming device	Mistral-Air Plus forced-air warming device

Primary Outcome Measures

Name	Time	Method
Body temperature-esophageal probe	Perioperative period-every 15 minutes	Esophageal probe used to measure core body temperature

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hacettepe University School of Medicine Hospital; 🇹🇷 Ankara, Turkey