Trial Outcomes & Findings for A Randomized Comparison of Intraoperative Warming With the LMA PerfecTemp and Forced-air (NCT NCT01094119)

NCT ID: NCT01094119

Last Updated: 2017-04-19

Results Overview

Time weighted average core temperature (esophogeal temperature) from tracheal intubation to 3 hours after or tracheal extubation

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 70 participants
• Primary outcome timeframe: from tracheal intubation to 3 hours after or tracheal extubation
• Results posted on: 2017-04-19

Participant Flow

Participant milestones

Measure	Bair Hugger Heated Blanket Patients will be warmed during surgery with the Bair Hugger heated blanket. heated blanket: heated blanket	LMA PerfecTemp System Patients will be warmed during surgery with the PerfecTemp heated pad . heated pad: patients will be warmed with a heated pad during surgery.
Overall Study STARTED	34	36
Overall Study COMPLETED	32	32
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Measure	Bair Hugger Heated Blanket Patients will be warmed during surgery with the Bair Hugger heated blanket. heated blanket: heated blanket	LMA PerfecTemp System Patients will be warmed during surgery with the PerfecTemp heated pad . heated pad: patients will be warmed with a heated pad during surgery.
Overall Study Lack of Efficacy	2	4

Baseline Characteristics

A Randomized Comparison of Intraoperative Warming With the LMA PerfecTemp and Forced-air

Baseline characteristics by cohort

Measure	Bair Hugger Heated Blanket n=34 Participants Patients will be warmed during surgery with the Bair Hugger heated blanket. heated blanket: heated blanket	LMA PerfecTemp System n=36 Participants Patients will be warmed during surgery with the PerfecTemp heated pad . heated pad: patients will be warmed with a heated pad during surgery.	Total n=70 Participants Total of all reporting groups
Age, Continuous	51 years STANDARD_DEVIATION 13 • n=5 Participants	51 years STANDARD_DEVIATION 15 • n=7 Participants	51 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	24 Participants n=7 Participants	43 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	12 Participants n=7 Participants	27 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	34 participants n=5 Participants	34 participants n=7 Participants	68 participants n=5 Participants
Race/Ethnicity, Customized Not Caucasian	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants	23 participants n=7 Participants	46 participants n=5 Participants
Region of Enrollment Canada	11 participants n=5 Participants	13 participants n=7 Participants	24 participants n=5 Participants
preoperative oral temperature	36.2 degrees C STANDARD_DEVIATION .9 • n=5 Participants	36.8 degrees C STANDARD_DEVIATION .8 • n=7 Participants	36.2 degrees C STANDARD_DEVIATION .8 • n=5 Participants

PRIMARY outcome

Timeframe: from tracheal intubation to 3 hours after or tracheal extubation

Population: Randomized patients.

Time weighted average core temperature (esophogeal temperature) from tracheal intubation to 3 hours after or tracheal extubation

Outcome measures

Measure	Bair Hugger Heated Blanket n=34 Participants Patients will be warmed during surgery with the Bair Hugger heated blanket. heated blanket: heated blanket	LMA PerfecTemp System n=36 Participants Patients will be warmed during surgery with the PerfecTemp heated pad . heated pad: patients will be warmed with a heated pad during surgery.
Time Weighted Average Core Temperature	36.11 Degrees C Standard Deviation .5	36.02 Degrees C Standard Deviation .55

SECONDARY outcome

Timeframe: at the end of surgery

Population: Enrolled patients

Proportion of patients with esophogeal temperatures above 36 degree at the end of surgery

Outcome measures

Measure	Bair Hugger Heated Blanket n=34 Participants Patients will be warmed during surgery with the Bair Hugger heated blanket. heated blanket: heated blanket	LMA PerfecTemp System n=36 Participants Patients will be warmed during surgery with the PerfecTemp heated pad . heated pad: patients will be warmed with a heated pad during surgery.
Proportion of Patients With Temperatures Above 36 Degree	30 Participants	21 Participants

Adverse Events

Bair Hugger Heated Blanket

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

LMA PerfecTemp 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

Daniel Sessler

Cleveland Clinc

Phone: 216-444-4900

Email: DS@OR.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place