Trial Outcomes & Findings for Zero Heat Flux Thermometry System Comparison Trial (NCT NCT01670760)
NCT ID: NCT01670760
Last Updated: 2020-09-22
Results Overview
Body temperature difference as defined by Agreement (bias - Zero heat flux thermometry minus nasopharyngeal) between simultaneously-acquired nasopharyngeal and forehead deep tissue temperatures as assessed by Bland and Altman repeated measures technique.
COMPLETED
NA
20 participants
Every 5 to 10 minutes, or as clinically indicated, for the duration of the surgery from the time of incision to the time of closure. The average duration of surgery was 57 minutes.
2020-09-22
Participant Flow
Participant milestones
| Measure |
Zero-Heat-Flux
This is a single arm study. All patients will have deep tissue temperature monitored from the nasopharyngeal and lateral forehead sites simultaneously.
Zero-heat-flux thermometry: The zero-heat-flux thermometer will be placed on the subject's lateral forehead for the duration of the surgery to measure deep tissue temperature.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Zero Heat Flux Thermometry System Comparison Trial
Baseline characteristics by cohort
| Measure |
Zero-Heat-Flux
n=20 Participants
This is a single arm study. All patients will have deep tissue temperature monitored from the nasopharyngeal and lateral forehead sites simultaneously.
Zero-heat-flux thermometry: The zero-heat-flux thermometer will be placed on the subject's lateral forehead for the duration of the surgery to measure deep tissue temperature.
|
|---|---|
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Age, Categorical
<=18 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
7.1 years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 5 to 10 minutes, or as clinically indicated, for the duration of the surgery from the time of incision to the time of closure. The average duration of surgery was 57 minutes.Body temperature difference as defined by Agreement (bias - Zero heat flux thermometry minus nasopharyngeal) between simultaneously-acquired nasopharyngeal and forehead deep tissue temperatures as assessed by Bland and Altman repeated measures technique.
Outcome measures
| Measure |
Zero-Heat-Flux
n=247 Observation
This is a single arm study. All patients will have deep tissue temperature monitored from the nasopharyngeal and lateral forehead sites simultaneously.
Zero-heat-flux thermometry: The zero-heat-flux thermometer will be placed on the subject's lateral forehead for the duration of the surgery to measure deep tissue temperature.
|
|---|---|
|
Body Temperature Difference in Degrees Celsius
|
-0.28 Degrees Celsius
Standard Error 0.027
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Adverse Events
Zero-Heat-Flux
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Zero-Heat-Flux
n=20 participants at risk
This is a single arm study. All patients will have deep tissue temperature monitored from the nasopharyngeal and lateral forehead sites simultaneously.
Zero-heat-flux thermometry: The zero-heat-flux thermometer will be placed on the subject's lateral forehead for the duration of the surgery to measure deep tissue temperature.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Redness at attachment site
|
55.0%
11/20 • Number of events 11 • For the duration of the surgery from the time of incision to the time of closure. The average duration of surgery was 57 minutes.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place