NCT02993666

Brief Summary

This study is conducted to evaluate the effectiveness of forced air warming using upper and lower body blankets by measuring core body temperature in patients undergoing video-assisted thoracic surgery in the lateral decubitus position over 2 hours of general anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 15, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

June 12, 2017

Status Verified

June 1, 2017

Enrollment Period

6 months

First QC Date

December 1, 2016

Last Update Submit

June 9, 2017

Conditions

Core Body Temperature

Outcome Measures

Primary Outcomes (1)

  • intraoperative incidence of hypothermia

    through surgery completion, up to 4 hours

Study Arms (2)

upper body

EXPERIMENTAL

warming with upper body blankets

Device: Bair Hugger

lower body

EXPERIMENTAL

warming with lower body blankets

Device: Bair Hugger

Interventions

Bair HuggerDEVICE

forced air warming with Bair Hugger air warmer

lower bodyupper body

Eligibility Criteria

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

You may qualify if:

  • patients undergoing video-assisted thoracic surgery over 2 hours
  • ASA I, II and III
  • age over 18 years

You may not qualify if:

  • refuse to enroll
  • patients with fever or hypothermia before surgery
  • patients who required changes of position during surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

  • Min SH, Yoon S, Yoon SH, Bahk JH, Seo JH. Randomised trial comparing forced-air warming to the upper or lower body to prevent hypothermia during thoracoscopic surgery in the lateral decubitus position. Br J Anaesth. 2018 Mar;120(3):555-562. doi: 10.1016/j.bja.2017.11.091. Epub 2017 Dec 5.

    PMID: 29452812DERIVED

Study Officials

  • JH Seo

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 1, 2016

First Posted

December 15, 2016

Study Start

December 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

June 12, 2017

Record last verified: 2017-06

Locations

KR(1)