Trial Outcomes & Findings for Evaluation of Core Body Temperature When Using Forced Air Warming or an Active Blanket to Prevent Perioperative Hypothermia (NCT NCT02079311)
NCT ID: NCT02079311
Last Updated: 2015-11-13
Results Overview
Temperature assessments will be made using an oesophageal temperature probe when the subject is under general anaesthesia and by oral thermometer for all other temperature assessments performed in pre-, intra- and post-op. The mean value is calculated on all temperature measured during pre-, intra- and post-op.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
55 participants
Primary outcome timeframe
Subjects will be followed for one day of hospital stay, data to be collected during the perioperative phase. Expected to be between 5-8 hours.
Results posted on
2015-11-13
Participant Flow
Participant milestones
| Measure |
Active Self-warming Blanket
Active warming with BARRIER® EasyWarm active self-warming blanket during the perioperative phase
Active self warming blanket: BARRIER® EasyWarm is a disposable self-warming blanket that produces heat via an exothermic chemical reaction initiated by exposure to air, resulting from the oxidation of iron.
|
Forced Air Warming Device
Active warming with forced air warming (FAW) during the intraoperative phase.
Forced air warming device: Forced air warming is a temperature management unit, where heated air is used to warm subjects through convection.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
27
|
|
Overall Study
COMPLETED
|
28
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Core Body Temperature When Using Forced Air Warming or an Active Blanket to Prevent Perioperative Hypothermia
Baseline characteristics by cohort
| Measure |
Active Self-warming Blanket
n=28 Participants
Active warming with BARRIER® EasyWarm active self-warming blanket during the perioperative phase
Active self warming blanket: BARRIER® EasyWarm is a disposable self-warming blanket that produces heat via an exothermic chemical reaction initiated by exposure to air, resulting from the oxidation of iron.
|
Forced Air Warming Device
n=27 Participants
Active warming with forced air warming (FAW) during the intraoperative phase.
Forced air warming device: Forced air warming is a temperature management unit, where heated air is used to warm subjects through convection.
|
Total
n=55 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
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
50 years
STANDARD_DEVIATION 14.44 • n=7 Participants
|
49.5 years
STANDARD_DEVIATION 13.82 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
15 participants
n=5 Participants
|
14 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Subjects will be followed for one day of hospital stay, data to be collected during the perioperative phase. Expected to be between 5-8 hours.Temperature assessments will be made using an oesophageal temperature probe when the subject is under general anaesthesia and by oral thermometer for all other temperature assessments performed in pre-, intra- and post-op. The mean value is calculated on all temperature measured during pre-, intra- and post-op.
Outcome measures
| Measure |
Active Self-warming Blanket
n=28 Participants
Active warming with BARRIER® EasyWarm active self-warming blanket during the perioperative phase
Active self warming blanket: BARRIER® EasyWarm is a disposable self-warming blanket that produces heat via an exothermic chemical reaction initiated by exposure to air, resulting from the oxidation of iron.
|
Forced Air Warming Device
n=27 Participants
Active warming with forced air warming (FAW) during the intraoperative phase.
Forced air warming device: Forced air warming is a temperature management unit, where heated air is used to warm subjects through convection.
|
|---|---|---|
|
The Difference in Core Body Temperature in the Two Treatment Groups.
|
36.28 degree celsius
Standard Deviation 0.3
|
36.25 degree celsius
Standard Deviation 0.33
|
Adverse Events
Active Self-warming Blanket
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Forced Air Warming Device
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active Self-warming Blanket
n=28 participants at risk
Active warming with BARRIER® EasyWarm active self-warming blanket during the perioperative phase
Active self warming blanket: BARRIER® EasyWarm is a disposable self-warming blanket that produces heat via an exothermic chemical reaction initiated by exposure to air, resulting from the oxidation of iron.
|
Forced Air Warming Device
n=27 participants at risk
Active warming with forced air warming (FAW) during the intraoperative phase.
Forced air warming device: Forced air warming is a temperature management unit, where heated air is used to warm subjects through convection.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
redness
|
42.9%
12/28 • Number of events 12
|
3.7%
1/27 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
hematoma
|
0.00%
0/28
|
3.7%
1/27 • Number of events 1
|
|
Vascular disorders
anaphylactic shock
|
0.00%
0/28
|
3.7%
1/27 • Number of events 1
|
Additional Information
Prof Alexander Torossian
Universitätsklinikum Gießen und Marburg GmbH
Phone: (+49) 06421 - 286 9864
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Investigator shall provide the Sponsor with a draft of the manuscript intended for publication or presentation at least \[14\] days before the date of intended submission for publication. However the Sponsor should be notified about the intention to publish the results at least \[14\] days before the manuscript is sent for review. All comments and suggested changes made by the Sponsor shall be considered in good faith in determining the final form of such publication.
- Publication restrictions are in place
Restriction type: OTHER