Clinical trial NCT04114604: Respiratory Capacity and Swallowing Function in Spinal Disorders: A Pilot Study
Official title: Respiratory Capacity and Swallowing Function in Spinal Disorders: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injuries
Deglutition Disorders
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2019-10-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will recruit participants from the inpatient SCI program at the Toronto Rehabilitation Institute Lyndhurst Center.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Number of Participants Displaying Unsafe Swallowing
timeFrame: Baseline (single timepoint only)
measure: Number of Participants Displaying Post-swallow Inhalation
timeFrame: Baseline (single timepoint only)
measure: Duration of the Respiratory Pause Seen in Swallowing
timeFrame: Baseline (single timepoint only)
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Rehabilitation Institute - Lyndhurst Centre
state: Ontario
Study officials:
affiliation: KITE - Toronto Rehabilitation Institute, University Health Network
name: Catriona Steele
role: PRINCIPAL_INVESTIGATOR
References: