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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01DC011020 | U.S. NIH Grant/Contract | View source | |
| CAPCR 16-6310 | Other Identifier | UHN Research Ethics Board |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal Cord Injury | Adults who have sustained a spinal cord injury at the cervical or upper thoracic level (T6 or higher). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (single timepoint only) |
| 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. | Baseline (single timepoint only) |
| 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. | Baseline (single timepoint only) |
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Inclusion Criteria:
Spinal cord injury at the cervical or thoracic level (T6 or higher)
Exclusion Criteria:
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We will recruit participants from the inpatient SCI program at the Toronto Rehabilitation Institute Lyndhurst Center.
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| Name | Affiliation | Role |
|---|---|---|
| Catriona Steele | KITE - Toronto Rehabilitation Institute, University Health Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto Rehabilitation Institute - Lyndhurst Centre | Toronto | Ontario | M4G 3V9 | Canada |
not planned at this time
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| ID | Title | Description |
|---|---|---|
| FG000 | Spinal Cord Injury | Adults who have sustained a spinal cord injury at the cervical or upper thoracic level (T6 or higher). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Spinal Cord Injury | Adults who have sustained a spinal cord injury at the cervical or upper thoracic level (T6 or higher). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Adults who have sustained a spinal cord injury at the cervical or upper thoracic level (T6 or higher). | Posted | Count of Participants | Participants | Baseline (single timepoint only) |
|
1 week following data collection
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Spinal Cord Injury | Adults who have sustained a spinal cord injury at the cervical or upper thoracic level (T6 or higher). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Swallowing Rehabilitation Research Laboratory | KITE Research Institute - Toronto Rehabilitation Institute, University Health Network | 416 597 3422 | 7802 | tri-swallowinglab@uhn.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 23, 2017 | Jun 15, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 28, 2017 | Jun 15, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | Slightly Thick Liquid Barium | 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. |
| OG002 | Mildly Thick Liquid Barium | 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. |
| OG003 | Moderately Thick Liquid Barium | 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. |
| OG004 | Extremely Thick Liquid Barium | 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. |
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| 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. | 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. | Posted | Count of Participants | Participants | Baseline (single timepoint only) |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | milliseconds | Baseline (single timepoint only) |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
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| D014947 | Wounds and Injuries |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |