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

University of Oslo (UIO)

Status: Unknown

Conditions: Surgery

Treatments: Device: Anaesthesia, Teles Pro, Body suit

Study type: Interventional

Funder types: Other

Identifiers

NCT02336152

Varmedrakt.OUS.15.1

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Body suit

Experimental group

Description:

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.

Treatment:

Device: Anaesthesia, Teles Pro, Body suit

Forced warm air

Active Comparator group

Description:

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

Treatment:

Device: Anaesthesia, Teles Pro, Body suit