NCT02336152

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable surgery

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable surgery

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 12, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

January 12, 2015

Status Verified

January 1, 2015

Enrollment Period

5 months

First QC Date

January 5, 2015

Last Update Submit

January 7, 2015

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

  • Body core temperature

    SpotOn (3M) measurement in the forehead

    30 minutes after anaesthesia induction

Secondary Outcomes (2)

  • Body core temperature

    1 hr before - intraoperative - 3 hrs postoperative

  • Patient termal satisfaction

    1 hr before - intraoperative - 3 hrs postoperative

Study Arms (2)

Body suit

EXPERIMENTAL

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

Forced warm air

ACTIVE COMPARATOR

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

Interventions

Anaesthesia, Teles Pro, Body suitDEVICE
Body suitForced warm air

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Anesthesiology, Oslo University Hospital, Ullevaal

Oslo, 0407, Norway

Location

MeSH Terms

Interventions

Anesthesia

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Central Study Contacts

Johan Raeder, PhD

CONTACT

004792249669johan.rader@medisin.uio.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2015

First Posted

January 12, 2015

Study Start

January 1, 2015

Primary Completion

June 1, 2015

Study Completion

July 1, 2015

Last Updated

January 12, 2015

Record last verified: 2015-01

Locations

NO(1)