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

Primary Purpose

Temperature Change, Body

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
HICO-VARIOTHERM 550
Mistral-Air Plus forced air warming device
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Temperature Change, Body

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hacettepe University School of Medicine Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group I

Group II

Arm Description

HICO-VARIOTHERM 550 and Mistral-Air Plus forced-air warming device

Mistral-Air Plus forced-air warming device

Outcomes

Primary Outcome Measures

Body temperature-esophageal probe
Esophageal probe used to measure core body temperature

Secondary Outcome Measures

Body temperature-tympanic thermometer
Tympanic thermometer used to measure body temperature
Body temperature-skin thermometer
Skin thermometer used to measure body temperature
Duration of operation
Duration of operation compared with the change in body temperature
Blood loss
Blood loss during the perioperative period
Shivering after the operation
Assessment of shivering after operation in the recovery room with PAS score
Time to extubation
Time to extubation at the end of operation

Full Information

First Posted
January 29, 2019
Last Updated
May 4, 2019
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT03824262
Brief Title
The Comparison of Warming Techniques in Patients Undergoing Open Abdominal Surgery in Litotomy Position
Official Title
The Comparison of Warming Techniques in Patients Undergoing Open Abdominal Surgery in Litotomy Position
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
February 4, 2019 (Actual)
Primary Completion Date
May 4, 2019 (Actual)
Study Completion Date
May 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temperature Change, Body

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Experimental
Arm Description
HICO-VARIOTHERM 550 and Mistral-Air Plus forced-air warming device
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
Mistral-Air Plus forced-air warming device
Intervention Type
Device
Intervention Name(s)
HICO-VARIOTHERM 550
Intervention Description
Warming during perioperative period.
Intervention Type
Device
Intervention Name(s)
Mistral-Air Plus forced air warming device
Intervention Description
Warming during perioperative period.
Primary Outcome Measure Information:
Title
Body temperature-esophageal probe
Description
Esophageal probe used to measure core body temperature
Time Frame
Perioperative period-every 15 minutes
Secondary Outcome Measure Information:
Title
Body temperature-tympanic thermometer
Description
Tympanic thermometer used to measure body temperature
Time Frame
Perioperative period-every 15 minutes
Title
Body temperature-skin thermometer
Description
Skin thermometer used to measure body temperature
Time Frame
Perioperative period-every 15 minutes
Title
Duration of operation
Description
Duration of operation compared with the change in body temperature
Time Frame
Perioperative period
Title
Blood loss
Description
Blood loss during the perioperative period
Time Frame
Perioperative period
Title
Shivering after the operation
Description
Assessment of shivering after operation in the recovery room with PAS score
Time Frame
Postoperative 1st hour every 10 minutes
Title
Time to extubation
Description
Time to extubation at the end of operation
Time Frame
The end of the operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meral Kanbak, Prof
Organizational Affiliation
Hacettepe University, School of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
FİLİZ UZUMCUGIL
Organizational Affiliation
Hacettepe University, School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hacettepe University School of Medicine Hospital
City
Ankara
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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