Trial Outcomes & Findings for Respiratory Capacity and Swallowing Function in Spinal Disorders: A Pilot Study (NCT NCT04114604)
NCT ID: NCT04114604
Last Updated: 2023-04-04
Results Overview
The Penetration-Aspiration Scale is an 8-point categorical scale that is used to characterize swallowing safety for each bolus based on the depth to which any material enters the airway and whether or not the material is ejected. Levels 1 and 2 on the scale are considered safe, while levels \> 2 are considered unsafe. Actual scale scores (1-8) will be recorded and then converted to binary categorical scores (\< 3 vs \>/= 3). We report the frequency (count) of participants showing unsafe swallowing (i.e., scores \> 2) by bolus consistency.
COMPLETED
10 participants
Baseline (single timepoint only)
2023-04-04
Participant Flow
Participant milestones
| Measure |
Spinal Cord Injury
Adults who have sustained a spinal cord injury at the cervical or upper thoracic level (T6 or higher).
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Respiratory Capacity and Swallowing Function in Spinal Disorders: A Pilot Study
Baseline characteristics by cohort
| Measure |
Spinal Cord Injury
n=10 Participants
Adults who have sustained a spinal cord injury at the cervical or upper thoracic level (T6 or higher).
|
|---|---|
|
Age, Continuous
|
49 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (single timepoint only)Population: Adults who have sustained a spinal cord injury at the cervical or upper thoracic level (T6 or higher).
The Penetration-Aspiration Scale is an 8-point categorical scale that is used to characterize swallowing safety for each bolus based on the depth to which any material enters the airway and whether or not the material is ejected. Levels 1 and 2 on the scale are considered safe, while levels \> 2 are considered unsafe. Actual scale scores (1-8) will be recorded and then converted to binary categorical scores (\< 3 vs \>/= 3). We report the frequency (count) of participants showing unsafe swallowing (i.e., scores \> 2) by bolus consistency.
Outcome measures
| Measure |
Thin Liquid Barium
n=10 Participants
Participants were asked to take a series of 3 comfortable sips of thin liquid barium prepared in 20% w/v concentration using Bracco E-Z-Paque powder and water.
|
Slightly Thick Liquid Barium
n=10 Participants
Participants were asked to take a series of 3 comfortable sips of slightly thick liquid barium prepared in 20% w/v concentration using Bracco E-Z-Paque powder, water and Nestle Resource ThickenUp Clear thickener.
|
Mildly Thick Liquid Barium
n=10 Participants
Participants were asked to take a series of 3 comfortable sips of mildly thick liquid barium prepared in 20% w/v concentration using Bracco E-Z-Paque powder, water and Nestle Resource ThickenUp Clear thickener.
|
Moderately Thick Liquid Barium
n=10 Participants
Participants were asked to take a series of 3 comfortable sips of moderately thick liquid barium prepared in 20% w/v concentration using Bracco E-Z-Paque powder, water and Nestle Resource ThickenUp Clear thickener.
|
Extremely Thick Liquid Barium
n=10 Participants
Participants were asked to take a series of 3 comfortable sips of extremely thick liquid barium prepared in 20% w/v concentration using Bracco E-Z-Paque powder, water and Nestle Resource ThickenUp Clear thickener.
|
|---|---|---|---|---|---|
|
Number of Participants Displaying Unsafe Swallowing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (single timepoint only)Population: A sample of 10 adults was enrolled. Due to signal quality issues, data were missing for one participant across all consistencies and for an additional participant on moderately thick liquid barium.
Healthy swallowing typically occurs partway through an outward breath, such that the direction of breathing both before and after the swallow is exhalation. Whenever a swallow is followed immediately by inhalation, this is considered abnormal and a risk for food or liquid material to be sucked into the airway. We measured the direction of breathing before and after swallows via nasal cannula using the airflow module of the KayPentax Digital Swallow Workstation Swallowing Signals Lab. We report the frequency (percentage) of participants displaying at least one swallow showing post-swallow inhalation by consistency.
Outcome measures
| Measure |
Thin Liquid Barium
n=9 Participants
Participants were asked to take a series of 3 comfortable sips of thin liquid barium prepared in 20% w/v concentration using Bracco E-Z-Paque powder and water.
|
Slightly Thick Liquid Barium
n=9 Participants
Participants were asked to take a series of 3 comfortable sips of slightly thick liquid barium prepared in 20% w/v concentration using Bracco E-Z-Paque powder, water and Nestle Resource ThickenUp Clear thickener.
|
Mildly Thick Liquid Barium
n=9 Participants
Participants were asked to take a series of 3 comfortable sips of mildly thick liquid barium prepared in 20% w/v concentration using Bracco E-Z-Paque powder, water and Nestle Resource ThickenUp Clear thickener.
|
Moderately Thick Liquid Barium
n=8 Participants
Participants were asked to take a series of 3 comfortable sips of moderately thick liquid barium prepared in 20% w/v concentration using Bracco E-Z-Paque powder, water and Nestle Resource ThickenUp Clear thickener.
|
Extremely Thick Liquid Barium
n=9 Participants
Participants were asked to take a series of 3 comfortable sips of extremely thick liquid barium prepared in 20% w/v concentration using Bracco E-Z-Paque powder, water and Nestle Resource ThickenUp Clear thickener.
|
|---|---|---|---|---|---|
|
Number of Participants Displaying Post-swallow Inhalation
|
2 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Baseline (single timepoint only)Population: A sample of 10 adults was enrolled. Due to signal quality issues, data were missing for one participant across all consistencies and for an additional participant on moderately thick liquid barium.
Healthy swallowing typically occurs partway through an outward (exhalatory) breath, and involves a pause in breathing. The duration of this respiratory pause was measured in milliseconds for each swallow based on the continuous airflow waveform collected via nasal cannula using the airflow module of the KayPentax Digital Swallow Workstation Swallowing Signals Lab. We report means and standard deviations for respiratory pause duration by consistency. Shorter respiratory pause durations reflect inadequate airway protection.
Outcome measures
| Measure |
Thin Liquid Barium
n=9 Participants
Participants were asked to take a series of 3 comfortable sips of thin liquid barium prepared in 20% w/v concentration using Bracco E-Z-Paque powder and water.
|
Slightly Thick Liquid Barium
n=9 Participants
Participants were asked to take a series of 3 comfortable sips of slightly thick liquid barium prepared in 20% w/v concentration using Bracco E-Z-Paque powder, water and Nestle Resource ThickenUp Clear thickener.
|
Mildly Thick Liquid Barium
n=9 Participants
Participants were asked to take a series of 3 comfortable sips of mildly thick liquid barium prepared in 20% w/v concentration using Bracco E-Z-Paque powder, water and Nestle Resource ThickenUp Clear thickener.
|
Moderately Thick Liquid Barium
n=8 Participants
Participants were asked to take a series of 3 comfortable sips of moderately thick liquid barium prepared in 20% w/v concentration using Bracco E-Z-Paque powder, water and Nestle Resource ThickenUp Clear thickener.
|
Extremely Thick Liquid Barium
n=9 Participants
Participants were asked to take a series of 3 comfortable sips of extremely thick liquid barium prepared in 20% w/v concentration using Bracco E-Z-Paque powder, water and Nestle Resource ThickenUp Clear thickener.
|
|---|---|---|---|---|---|
|
Duration of the Respiratory Pause Seen in Swallowing
|
901 milliseconds
Standard Deviation 485
|
996 milliseconds
Standard Deviation 573
|
867 milliseconds
Standard Deviation 455
|
721 milliseconds
Standard Deviation 275
|
815 milliseconds
Standard Deviation 541
|
Adverse Events
Spinal Cord Injury
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director, Swallowing Rehabilitation Research Laboratory
KITE Research Institute - Toronto Rehabilitation Institute, University Health Network
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place