Trial Outcomes & Findings for CPAP to Improve Swallow Function Post Total Laryngectomy (NCT NCT03328702)
NCT ID: NCT03328702
Last Updated: 2024-12-24
Results Overview
This is the time in seconds that it takes for a bolus to move from the oral cavity, through the pharynx, and into the so. It is measured in seconds and is the primary outcome measure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
4 participants
Primary outcome timeframe
During VFSE (1 day)
Results posted on
2024-12-24
Participant Flow
Participant milestones
| Measure |
Continue Positive Airway Pressure
Continue Positive Airway Pressure during VFSE
Continuous Positive Airway Pressure: Apex XT Fit CPAP Machine
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CPAP to Improve Swallow Function Post Total Laryngectomy
Baseline characteristics by cohort
| Measure |
Continue Positive Airway Pressure
n=4 Participants
Continue Positive Airway Pressure during VFSE
Continuous Positive Airway Pressure: Apex XT Fit CPAP Machine
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
|
Total Pharyngeal Transit Time @ Baseline (No CPAP)
|
26.88 seconds
STANDARD_DEVIATION 12.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: During VFSE (1 day)Population: The total pharyngeal transit time
This is the time in seconds that it takes for a bolus to move from the oral cavity, through the pharynx, and into the so. It is measured in seconds and is the primary outcome measure.
Outcome measures
| Measure |
Continue Positive Airway Pressure
n=4 Participants
Continue Positive Airway Pressure during VFSE
Continuous Positive Airway Pressure: Apex XT Fit CPAP Machine
|
|---|---|
|
Total Pharyngeal Transit Time (With CPAP)
|
10.18 seconds
Standard Deviation 8.5
|
Adverse Events
Continue Positive Airway Pressure
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place