Use of Onepiece Suit or Forced Warm Air for Perioperative Temperature Conservation.

January 7, 2015 updated by: Oslo University Hospital
To study if a one piece body suite (T-balance, Telespro, Finland) is equally effective in maintaining peri-operative body temperature as forced air warming, during open low-back surgery of medium duration.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

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

  • Norway
      • Oslo, Norway, 0407
        • Dept of Anesthesiology, Oslo University Hospital, Ullevaal

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA 1-3
  • Approved consent
  • Expected duration of open back surgery of 60-120 min
  • Prestudy core temperature (oral) of at least 36 degrees C

Exclusion Criteria:

  • Known diabetes mellitus
  • Any known illness or use of pre-op drugs which may interfere with normal temperature regulation
  • Body mass index less than 17 or more than 35
  • Pregnancy
  • Any contraindication for warming device or temperature monitor

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Body suit
The patients will receive a body suit at least 30 min before start of general anaesthesia, and will keep the suit on until warm and comfortable in the post-operative unit. The suit is supplied with multiple snap openings to allow for draping, washing and surgery.
Device: Anaesthesia, Teles Pro, Body suit
Active Comparator: Forced warm air
The patients will receive forced warm air on their lower body when placed on operating table, ready for surgery.
Device: Anaesthesia, Teles Pro, Body suit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body core temperature
Time Frame: 30 minutes after anaesthesia induction
SpotOn (3M) measurement in the forehead
30 minutes after anaesthesia induction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body core temperature
Time Frame: 1 hr before - intraoperative - 3 hrs postoperative
1 hr before - intraoperative - 3 hrs postoperative
Patient termal satisfaction
Time Frame: 1 hr before - intraoperative - 3 hrs postoperative
patient interview
1 hr before - intraoperative - 3 hrs postoperative

Collaborators and Investigators

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

Sponsor

Oslo University Hospital

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

January 1, 2015

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

January 5, 2015

First Submitted That Met QC Criteria

January 7, 2015

First Posted (Estimate)

January 12, 2015

Study Record Updates

Last Update Posted (Estimate)

January 12, 2015

Last Update Submitted That Met QC Criteria

January 7, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Varmedrakt.OUS.15.1

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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