Trial Outcomes & Findings for Study to Evaluate Safety and Efficacy of Blanket Used to Prevent Anesthesia Induced Hypothermia (NCT NCT01900067)

Results Overview

The subject's core body temperature at any time point is approximated by the arithmetic mean of three repeated tympanic temperature measurements every 15 minutes during the perioperative period

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

271 participants

Primary outcome timeframe

temperature measurments during pre,-intra and postoperative period, on average 1-5 hours, depending on the surgical intervention.

Results posted on

2015-05-06

Participant Flow

Participant milestones

Participant milestones
Measure	Active Warming BARRIER® EasyWarm Active Self-Warming Blanket BARRIER® EasyWarm Active Self-Warming Blanket	Control no active warming, standard of care
Overall Study STARTED	134	137
Overall Study COMPLETED	122	124
Overall Study NOT COMPLETED	12	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Evaluate Safety and Efficacy of Blanket Used to Prevent Anesthesia Induced Hypothermia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Warming n=122 Participants BARRIER® EasyWarm Active Self-Warming Blanket	Control n=124 Participants no active warming, standard of care	Total n=246 Participants Total of all reporting groups
Age, Customized Age	46.5 years STANDARD_DEVIATION 15.3 • n=5 Participants	45.6 years STANDARD_DEVIATION 14.8 • n=7 Participants	46.1 years STANDARD_DEVIATION 15.1 • n=5 Participants
Sex: Female, Male Female	92 Participants n=5 Participants	96 Participants n=7 Participants	188 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	28 Participants n=7 Participants	58 Participants n=5 Participants

PRIMARY outcome

Timeframe: temperature measurments during pre,-intra and postoperative period, on average 1-5 hours, depending on the surgical intervention.

The subject's core body temperature at any time point is approximated by the arithmetic mean of three repeated tympanic temperature measurements every 15 minutes during the perioperative period

Outcome measures

Outcome measures
Measure	Active Warming n=122 Participants BARRIER® EasyWarm Active Self-Warming Blanket	Control n=124 Participants No active warming, standard of care
The Difference in the Arithmetic Mean of Core Body Temperature Measurements During the Perioperative Phase Between the Interventional Treatment Group and the Control Treatment Group	36.52 Degree Celsius (°C) Interval 36.15 to 36.89	36.34 Degree Celsius (°C) Interval 36.0 to 36.74

Adverse Events

Active Warming

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Active Warming n=134 participants at risk BARRIER® EasyWarm Active Self-Warming Blanket	Control n=137 participants at risk No active warming, standard of care
Skin and subcutaneous tissue disorders Redness of skin	17.2% 23/134 • Number of events 23	0.00% 0/137

Additional Information

Jenny Höglind

Mölnlycke Health Care AB, Surgical Division

Phone: 0046 31 722 30 00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The agreement state that sponsor is the owner of all results. The Investigator may perform a secondary publication from an individual investigation site without disclosing confidential information received from sponsor after the multi-center publication or within 12 months after termination of the investigation if no such multi-centre publication takes place.
Publication restrictions are in place

Restriction type: OTHER