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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02336152
• Other study ID #: Varmedrakt.OUS.15.1
• Status: Not yet recruiting
• Phase: N/A
• First received: January 5, 2015
• Last updated: January 7, 2015
• Start date: January 2015
• Est. completion date: July 2015

Study information

• Verified date: January 2015
• Source: Oslo University Hospital
• Contact: Johan Raeder, PhD
• Phone: 004792249669
• Email: johan.rader[@]medisin.uio.no
• Is FDA regulated: No
• Health authority: Norway: Oslo University Hospital
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Surgery

Intervention

Device:
• Anaesthesia, Teles Pro, Body suit

Locations

Country	Name	City	State
Norway	Dept of Anesthesiology, Oslo University Hospital, Ullevaal	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body core temperature	SpotOn (3M) measurement in the forehead	30 minutes after anaesthesia induction	No
Secondary	Body core temperature		1 hr before - intraoperative - 3 hrs postoperative	No
Secondary	Patient termal satisfaction	patient interview	1 hr before - intraoperative - 3 hrs postoperative	No