Trial Outcomes & Findings for The Impact of High-Flow Nasal Cannula on Swallow Function (NCT NCT03590457)
NCT ID: NCT03590457
Last Updated: 2022-09-27
Results Overview
Number of swallows
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
each swallow frequency exam took 1 minute, exams were done for each flow rate which took up to 2 hours to complete
Results posted on
2022-09-27
Participant Flow
Participant milestones
| Measure |
High-Flow/Swallow
All participants will be subjected to all three flows randomly. All participants will be asked swallow water and applesauce
Airvo 2; High-Flow nasal cannula system: Noninvasive device used to deliver humidified oxygen at high flow rates up to 60 liters per minute
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
High-Flow/Swallow
n=18 Participants
All participants will be subjected to all three flows randomly. All participants will be asked swallow water and applesauce
Airvo 2; High-Flow nasal cannula system: Noninvasive device used to deliver humidified oxygen at high flow rates up to 60 liters per minute
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=18 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=18 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=18 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=18 Participants
|
PRIMARY outcome
Timeframe: each swallow frequency exam took 1 minute, exams were done for each flow rate which took up to 2 hours to completePopulation: swallow frequency
Number of swallows
Outcome measures
| Measure |
High-Flow/Swallow
n=18 Participants
All participants will be subjected to all three flows randomly. All participants will be asked swallow water and applesauce
Airvo 2; High-Flow nasal cannula system: Noninvasive device used to deliver humidified oxygen at high flow rates up to 60 liters per minute
|
|---|---|
|
Swallow Frequency Recorded by Surface Electromyography (sEMG)
swallow frequency at baseline
|
1.12 number of swallows
Standard Deviation 0.75
|
|
Swallow Frequency Recorded by Surface Electromyography (sEMG)
swallow frequency at 30 L/min
|
1.13 number of swallows
Standard Deviation 0.79
|
|
Swallow Frequency Recorded by Surface Electromyography (sEMG)
swallow frequency at 45 L/min
|
3.91 number of swallows
Standard Deviation 10.26
|
|
Swallow Frequency Recorded by Surface Electromyography (sEMG)
swallow frequency at 60 L/min
|
1.01 number of swallows
Standard Deviation 0.67
|
Adverse Events
High-Flow/Swallow
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