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

May 4, 2019 updated by: Filiz Uzumcugil, Hacettepe University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Hacettepe University School of Medicine Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

  • Study Chair: Meral Kanbak, Prof, Hacettepe University, School of Medicine
  • Principal Investigator: FİLİZ UZUMCUGIL, Hacettepe University, School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2019

Primary Completion (Actual)

May 4, 2019

Study Completion (Actual)

May 4, 2019

Study Registration Dates

First Submitted

January 29, 2019

First Submitted That Met QC Criteria

January 29, 2019

First Posted (Actual)

January 31, 2019

Study Record Updates

Last Update Posted (Actual)

May 7, 2019

Last Update Submitted That Met QC Criteria

May 4, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E.308215

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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