Trial Outcomes & Findings for Efficacy of Warming Device During Surgery (NCT NCT00715728)

Results Overview

The primary outcome was the rewarming rate during active heating over a core temperature range from 35°C to 37°C.

Recruitment status

COMPLETED

Target enrollment

28 participants

Primary outcome timeframe

Until the end of surgery, up to 5 hour

Results posted on

2018-07-16

Participant Flow

Participant milestones

Participant milestones
Measure	Intra-operative Rewarming With Bair Hugger Heating Intra-operative rewarming with Bair Hugger heating system	Intraoperative Rewarming With Hot Dog Resistive Heating Intraoperative rewarming with Hot Dog resistive heating system
Overall Study STARTED	14	14
Overall Study COMPLETED	14	14
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Warming Device During Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bair Hugger Forced Air System n=14 Participants Patients were warmed with the Bair Hugger forced air system during surgery.	Hot Dog Resistive Heating System n=14 Participants Patients were warmed with the Hot Dog resistive heating system during surgery.	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment Austria	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants

PRIMARY outcome

Timeframe: Until the end of surgery, up to 5 hour

The primary outcome was the rewarming rate during active heating over a core temperature range from 35°C to 37°C.

Outcome measures

Outcome measures
Measure	Intra-operative Rewarming With Hot Dog n=14 Participants Intraoperative warming with Bair Hugger forced air system	Intra-operative Rewarming With Forced-air Heating n=14 Participants Intraoperative warming with forced-air heating system
The Rate of Core Rewarming Over the Range From 35°C to 37°C.	.24 degrees Celcius / hr Standard Error .025	.49 degrees Celcius / hr Standard Error .027

PRIMARY outcome

Timeframe: Until the end of surgery, up to 5 hour

Population: Medical University of Vienna adults having major maxillary-facial reconstructive surgery expected to last about 5 h. Most had pectoral flap reconstructions after extensive cancer debridement. We did not study patients with Reynaud's disease, thyroid dysfunction, insulin-dependent diabetes mellitus, or who were of ASA physical status \> 3.

Temperatures during surgery were recorded at 15-min intervals and summarize as time weighted average (TWA) for each patient. The unit of TWA-temperature is °C.

Outcome measures

Outcome measures
Measure	Intra-operative Rewarming With Hot Dog n=14 Participants Intraoperative warming with Bair Hugger forced air system	Intra-operative Rewarming With Forced-air Heating n=14 Participants Intraoperative warming with forced-air heating system
Intraoperative Time Weighted Average Core Temperature	36.24 degrees as measured in Celcius Standard Error 0.27	36.12 degrees as measured in Celcius Standard Error 0.25

Adverse Events

Bair Hugger Forced Air System

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Hot Dog Resistive Heating System

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Olga Plattner, Medical Doctor

Vienna General Hospital/University of Vienna

Phone: 43-1-40-400-4103

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place