Spinal Cord InjuriesNCT04114604
Respiratory Capacity and Swallowing Function in Spinal Disorders: A Pilot Study
An observational study of Spinal Cord Injuries and Deglutition Disorders, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Spinal Cord Injuries, Deglutition Disorders
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 30 Mar 2017to 1 Mar 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We will recruit participants from the inpatient SCI program at the Toronto Rehabilitation Institute Lyndhurst Center.
Who may be able to join
- Spinal cord injury at the cervical or thoracic level (T6 or higher)
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto Rehabilitation Institute - Lyndhurst Centre
Toronto, Ontario, M4G 3V9
About this study
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.
Read the 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.
- Conditions
- Spinal Cord Injuries, Deglutition Disorders
- Medical subject headings
- Spinal Cord Injuries, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Cord Injury | Adults who have sustained a spinal cord injury at the cervical or upper thoracic level (T6 or higher). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline (single timepoint only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start30 Mar 2017
- Primary completion31 Dec 2019
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Catriona Steele, Principal investigator, KITE - Toronto Rehabilitation Institute, University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114604
- Sponsor's protocol ID
- 16-6310
- Other IDs
- 5R01DC011020, CAPCR 16-6310
- Status last verified
- Apr 2023
- First submitted
- 27 Sep 2019
- Last updated
- 4 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not planned at this time
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Capacity and Swallowing Function in Spinal Disorders: A Pilot Study
- ClinicalTrials.gov ID
- NCT04114604
- Acronym / sponsor ID
- 16-6310
- Conditions
- Spinal Cord Injuries, Deglutition Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 3 Oct 2019 (actual)
- Results
- Posted 13 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal Cord Injury | – | –Adults who have sustained a spinal cord injury at the cervical or upper thoracic level (T6 or higher). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will recruit participants from the inpatient SCI program at the Toronto Rehabilitation Institute Lyndhurst Center.
Key inclusion criteria (1 listed)
- Spinal cord injury at the cervical or thoracic level (T6 or higher)
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants Displaying Unsafe Swallowing
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. not planned at this time
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catriona Steele principal investigator
KITE - Toronto Rehabilitation Institute, University Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries and Deglutition Disorders, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Displaying Unsafe Swallowing (time frame: Baseline (single timepoint only)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.