Trial Outcomes & Findings for Voice Analysis as a Predictor for Difficult Intubations (NCT NCT04105738)
NCT ID: NCT04105738
Last Updated: 2022-03-15
Results Overview
An audio sample from each participant will be broken down into its signal components using signal-processing methods to evaluate whether there are differences between the two participant groups which may correlate to difficult intubation.
TERMINATED
13 participants
15-20 minutes
2022-03-15
Participant Flow
Participant milestones
| Measure |
Difficult Airways
Documented history of difficult airways.
|
Control (Not Difficult Airways)
Age matched with normal airways to be used as controls
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
0
|
|
Overall Study
COMPLETED
|
13
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Voice Analysis as a Predictor for Difficult Intubations
Baseline characteristics by cohort
| Measure |
Difficult Airways
n=13 Participants
Documented history of difficult airways.
|
Control (Not Difficult Airways)
Age matched with normal airways to be used as controls
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
n=99 Participants
|
—
|
59 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=99 Participants
|
—
|
13 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 15-20 minutesPopulation: Terminated: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention. Signal processing of the audio samples did not work as anticipated and could not be abstracted or analyzed. Additionally, not enough participants were enrolled, including lack of enrollment to the control group, to analyze data.
An audio sample from each participant will be broken down into its signal components using signal-processing methods to evaluate whether there are differences between the two participant groups which may correlate to difficult intubation.
Outcome measures
Outcome data not reported
Adverse Events
Difficult Airways
Control (Not Difficult Airways)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place