NCT03163563

Brief Summary

The purpose of the study is to measure patient- temperature in the perioperative period of patients undergoing plastic surgery in an ambulatory surgical unit. This study will evaluate if active warming with self-warming blanket (Easywarm®) is as effective as active warming with forced-air blanket (BairHugger®). Second the study will evaluate if one or both methods is effective in preventing perioperative hypothermia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2016

Shorter than P25 for all trials

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

Study Start

First participant enrolled

March 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
12 months until next milestone

First Posted

Study publicly available on registry

May 23, 2017

Completed
Last Updated

May 23, 2017

Status Verified

May 1, 2017

Enrollment Period

3 months

First QC Date

March 2, 2016

Last Update Submit

May 21, 2017

Conditions

Perioperative/Postoperative Complications

Outcome Measures

Primary Outcomes (1)

  • Temperature

    Temperature Celsius measured by SpotOn 3M

    Perioperative period

Secondary Outcomes (2)

  • Medication given during study period

    Perioperative period

  • Temperature Numerical Rating Scale

    Perioperative period.

Study Arms (2)

Easywarm

Self warming blanket to prevent perioperative hypothermia

Device: Easywarm

BairHugger

Forced-air warming blanket to prevent perioperative hypothermia

Device: BairHugger

Interventions

EasywarmDEVICE

Warming blanket

Easywarm
BairHuggerDEVICE

Patient warming mattress with continuous warm air.

BairHugger

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients planned for plastic surgery with planned total anestesia for more than 60 minutes are enrolled consecutively.

You may qualify if:

  • Patients for planned plastic surgery with duration of general anesthesia ≥ 60 minutes.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aleris Solsiden

Trondheim, Sør-Trøndelag, 7014, Norway

Location

Related Publications (1)

  • Tyvold SS. Preventing hypothermia in outpatient plastic surgery by self-warming or forced-air-warming blanket: A randomised controlled trial. Eur J Anaesthesiol. 2019 Nov;36(11):843-850. doi: 10.1097/EJA.0000000000001087.

    PMID: 31567576DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stig S Tyvold, MD PhD

    Aleris Helse AS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2016

First Posted

May 23, 2017

Study Start

March 1, 2016

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

May 23, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)