Respiratory Capacity and Swallowing Function in Spinal Disorders: A Pilot Study

NCT04114604 | Completed Results

• 3 other identifiers: 16-63105R01DC011020CAPCR 16-6310
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Deglutition Disorders

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (1)

Spinal Cord Injury

Adults who have sustained a spinal cord injury at the cervical or upper thoracic level (T6 or higher).

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will recruit participants from the inpatient SCI program at the Toronto Rehabilitation Institute Lyndhurst Center.

You may qualify if:

• Spinal cord injury at the cervical or thoracic level (T6 or higher)

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Health Network, Toronto: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Toronto Rehabilitation Institute - Lyndhurst Centre

Toronto, Ontario, M4G 3V9, Canada

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Deglutition Disorders

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Director, Swallowing Rehabilitation Research Laboratory
• Organization: KITE Research Institute - Toronto Rehabilitation Institute, University Health Network

tri-swallowinglab@uhn.ca

416 597 3422

Study Officials

• Catriona Steele

  KITE - Toronto Rehabilitation Institute, University Health Network

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2019
• First Posted: October 3, 2019
• Study Start: March 30, 2017
• Primary Completion: December 31, 2019
• Study Completion: March 1, 2020
• Last Updated: April 4, 2023
• Results First Posted: July 13, 2022

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)