Trial Outcomes & Findings for Impact of Expanded Peri Operative Warming (NCT NCT01649596)

NCT ID: NCT01649596

Last Updated: 2018-04-05

Results Overview

The primary outcome is the incidence of hypothermic events (core \<36 degrees celsius).

Recruitment status

COMPLETED

Study phase

Target enrollment

94 participants

Primary outcome timeframe

12 hours

Results posted on

2018-04-05

Participant Flow

Inpatients having surgery between September 1, 2012 through April 9, 2013.

Patients presenting with emergencies or with trauma were excluded.

Participant milestones

Participant milestones
Measure	3M Bair Paws Flex Gown 3M Bair Paws Flex Warming Gown and 3M Bair Paws Model 875 Warming Unit 3M Bair Paws Flex Gown and Bair Paws Model 875 Warmer	Control Standard of care warm blankets
Overall Study STARTED	46	48
Overall Study COMPLETED	46	48
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impact of Expanded Peri Operative Warming

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	3M Bair Paws Flex Gown n=46 Participants 3M Bair Paws Flex Warming Gown and 3M Bair Paws Model 875 Warming Unit 3M Bair Paws Flex Gown and Bair Paws Model 875 Warmer	Control n=48 Participants Standard of care, warm blankets Standard of care - warm blankets	Total n=94 Participants Total of all reporting groups
Age, Continuous	51.8 years STANDARD_DEVIATION 14.9 • n=5 Participants	48.5 years STANDARD_DEVIATION 15.1 • n=7 Participants	50.1 years STANDARD_DEVIATION 15.0 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	28 Participants n=7 Participants	65 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	20 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	41 Participants n=5 Participants	44 Participants n=7 Participants	85 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	46 participants n=5 Participants	48 participants n=7 Participants	94 participants n=5 Participants
BMI	32.6 Kg/m^2 STANDARD_DEVIATION 7.9 • n=5 Participants	29.8 Kg/m^2 STANDARD_DEVIATION 7.1 • n=7 Participants	31.2 Kg/m^2 STANDARD_DEVIATION 7.6 • n=5 Participants
Pulse	76.2 bpm STANDARD_DEVIATION 12.2 • n=5 Participants	74.2 bpm STANDARD_DEVIATION 15.2 • n=7 Participants	75.2 bpm STANDARD_DEVIATION 13.8 • n=5 Participants
Temperature	36.8 Celsius STANDARD_DEVIATION 0.4 • n=5 Participants	36.5 Celsius STANDARD_DEVIATION 0.3 • n=7 Participants	36.7 Celsius STANDARD_DEVIATION 0.4 • n=5 Participants

PRIMARY outcome

Timeframe: 12 hours

The primary outcome is the incidence of hypothermic events (core \<36 degrees celsius).

Outcome measures

Outcome measures
Measure	3M Bair Paws Flex Gown n=46 Participants 3M Bair Paws Flex Warming Gown and 3M Bair Paws Model 875 Warming Unit 3M Bair Paws Flex Gown and Bair Paws Model 875 Warmer	Control n=48 Participants Standard of care warm blankets
Incidence of Hypothermic Events	5 participants	10 participants

SECONDARY outcome

Timeframe: 12 hours

Population: All patients completed the patient anxiety and satisfaction survey.

Secondary outcome is the relative change (%) in patient satisfaction score from pre-op to recovery. Pre-procedure and Post-procedure surveys were given to the participants to complete. Pre-procedure survey contained 9 questions and the post-procedure survey contained 6 questions. The questions were related to comfort, anxiety and satisfaction. A questionnaire was designed with 6 questions (2 pt and 4 pt Likert sub scales) combined. The overall scores were additive and ranged from 5 to 18 points (5 indicating the least anxiety and 18 indicating the highest anxiety). Individual scores were summed, averaged and group averages compared. The relative change in the percent of participants satisfied (somewhat \& highly) was calculated for each group. The change in percent satisfied was calculated for each group and compared.

Outcome measures

Outcome measures
Measure	3M Bair Paws Flex Gown n=46 Participants 3M Bair Paws Flex Warming Gown and 3M Bair Paws Model 875 Warming Unit 3M Bair Paws Flex Gown and Bair Paws Model 875 Warmer	Control n=48 Participants Standard of care warm blankets
Patient Satisfaction	59 change in percent satisfied	49 change in percent satisfied

Adverse Events

3M Bair Paws Flex Gown

Serious events: 0 serious events

Other events: 0 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

Adverse event data not reported

Additional Information

Surgeon

Genesys Regional Medical Center

Phone: 810-606-6500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place