Deglutition Disorders, Spinal Cord Injuries
Conditions
Brief summary
This study is part of a larger grant, for which the overall goal is to collect measurements of liquid flow through the oropharynx (i.e., mouth and throat) during swallowing.The focus of this study is to evaluate the flow of liquids of varying consistency in the spinal disorder population.
Detailed description
Thickened liquids are commonly used as an intervention for dysphagia (swallowing impairment). However, the field lacks a clear understanding of how liquids of different consistencies behave during swallowing. In order to improve understanding of the effectiveness of altered liquid consistency for improving dysphagia, the investigators are studying liquid flow through the oropharynx. This study explores this question in individuals with spinal cord injury. Participants will swallow 20% w/v barium thickened to different consistencies (thin, slightly thick, mildly thick, moderately thick and extremely thick). Swallowing will be observed under videofluoroscopy. Simultaneous measures of airflow via nasal cannula will be used to study respiratory-swallow coordination in this study sample.
Interventions
None listed
Sponsors
National Institute on Deafness and Other Communication Disorders (NIDCD)
University Health Network, Toronto
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
Spinal cord injury at the cervical or thoracic level (T6 or higher)
Exclusion criteria
* Prior history of swallowing, motor speech, gastro-esophageal difficulties, chronic sinusitis or taste disturbance. * Neurological difficulties unrelated to spinal disorder (e.g. Stroke, Parkinson disease, etc). * Cognitive communication difficulties that may hinder ability to participate. * Current use of mechanical ventilation * External instrumentation around the head/neck that would obstruct the field of view during the videofluoroscopy exam (e.g. cervical collar). * Type 1 Diabetes (due to the requirement to swallow stimuli containing starch based thickeners, which carry a significant carbohydrate load). * Known allergies to latex, food coloring or dental glue (due to the probability that these items will come into contact with the oral mucosa during data collection). * Children and pregnant women (due to the use of radiation during the videofluoroscopic examination).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Displaying Unsafe Swallowing | Baseline (single timepoint only) | 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. |
| Number of Participants Displaying Post-swallow Inhalation | Baseline (single timepoint only) | 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. |
| Duration of the Respiratory Pause Seen in Swallowing | Baseline (single timepoint only) | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Spinal Cord Injury Adults who have sustained a spinal cord injury at the cervical or upper thoracic level (T6 or higher). | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Spinal Cord Injury |
|---|---|
| Age, Continuous | 49 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment Canada | 10 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Duration of the Respiratory Pause Seen in Swallowing
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thin Liquid Barium | Duration of the Respiratory Pause Seen in Swallowing | 901 milliseconds | Standard Deviation 485 |
| Slightly Thick Liquid Barium | Duration of the Respiratory Pause Seen in Swallowing | 996 milliseconds | Standard Deviation 573 |
| Mildly Thick Liquid Barium | Duration of the Respiratory Pause Seen in Swallowing | 867 milliseconds | Standard Deviation 455 |
| Moderately Thick Liquid Barium | Duration of the Respiratory Pause Seen in Swallowing | 721 milliseconds | Standard Deviation 275 |
| Extremely Thick Liquid Barium | Duration of the Respiratory Pause Seen in Swallowing | 815 milliseconds | Standard Deviation 541 |
Primary
Number of Participants Displaying Post-swallow Inhalation
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Thin Liquid Barium | Number of Participants Displaying Post-swallow Inhalation | 2 Participants |
| Slightly Thick Liquid Barium | Number of Participants Displaying Post-swallow Inhalation | 5 Participants |
| Mildly Thick Liquid Barium | Number of Participants Displaying Post-swallow Inhalation | 3 Participants |
| Moderately Thick Liquid Barium | Number of Participants Displaying Post-swallow Inhalation | 1 Participants |
| Extremely Thick Liquid Barium | Number of Participants Displaying Post-swallow Inhalation | 2 Participants |
Primary
Number of Participants Displaying Unsafe Swallowing
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.
Time frame: Baseline (single timepoint only)
Population: Adults who have sustained a spinal cord injury at the cervical or upper thoracic level (T6 or higher).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Thin Liquid Barium | Number of Participants Displaying Unsafe Swallowing | 0 Participants |
| Slightly Thick Liquid Barium | Number of Participants Displaying Unsafe Swallowing | 0 Participants |
| Mildly Thick Liquid Barium | Number of Participants Displaying Unsafe Swallowing | 0 Participants |
| Moderately Thick Liquid Barium | Number of Participants Displaying Unsafe Swallowing | 0 Participants |
| Extremely Thick Liquid Barium | Number of Participants Displaying Unsafe Swallowing | 0 Participants |