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

NCT ID: NCT02336152

Last Updated: 2015-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Anaesthesia, Teles Pro, Body suit

Intervention Type DEVICE

Forced warm air

The patients will receive forced warm air on their lower body when placed on operating table, ready for surgery.

Group Type ACTIVE_COMPARATOR

Anaesthesia, Teles Pro, Body suit

Intervention Type DEVICE

Interventions

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Anaesthesia, Teles Pro, Body suit

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dept of Anesthesiology, Oslo University Hospital, Ullevaal

Oslo, , Norway

Site Status

Countries

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Norway

Central Contacts

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Johan Raeder, PhD

Role: CONTACT

004792249669

Other Identifiers

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Varmedrakt.OUS.15.1

Identifier Type: -

Identifier Source: org_study_id

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