NCT04114604

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

Completed Results posted Last updated 4 April 2023

What this trial tests

trial in Spinal Cord Injuries in 10 participants. Completed in 1 March 2020.

Timeline

30 March 2017

Primary endpoint
31 December 2019

1 March 2020

Quick facts

Lead sponsor	University Health Network, Toronto
Status	Completed
Study type	OBSERVATIONAL
Enrollment	10
Start date	30 March 2017
Primary completion	31 December 2019
Estimated completion	1 March 2020
Sites	1 location across Canada

Conditions studied

• Spinal Cord Injuries — all drugs for Spinal Cord Injuries →
• Deglutition Disorders — all drugs for Deglutition Disorders →

Sponsor

University Health Network, Toronto

Who can join

Adults 18 to 100, any sex, with Spinal Cord Injuries or Deglutition Disorders. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Displaying Unsafe Swallowing Primary · 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.

Group	Value	95% CI
Thin Liquid Barium	0
Slightly Thick Liquid Barium	0
Mildly Thick Liquid Barium	0
Moderately Thick Liquid Barium	0
Extremely Thick Liquid Barium	0

Number of Participants Displaying Post-swallow Inhalation Primary · 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 inhal

Group	Value	95% CI
Thin Liquid Barium	2
Slightly Thick Liquid Barium	5
Mildly Thick Liquid Barium	3
Moderately Thick Liquid Barium	1
Extremely Thick Liquid Barium	2

Duration of the Respiratory Pause Seen in Swallowing Primary · 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.

Group	Value	95% CI
Thin Liquid Barium	901	± 485
Slightly Thick Liquid Barium	996	± 573
Mildly Thick Liquid Barium	867	± 455
Moderately Thick Liquid Barium	721	± 275
Extremely Thick Liquid Barium	815	± 541

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The effect of liquid consistency on penetration-aspiration: a Bayesian analysis of two large datasets.
   Borders JC, Steele CM. · · 2024 · cited 5× · PMID 38463609 · DOI 10.3389/fresc.2024.1337971
2. Automated detection of chewing movements in videofluoroscopic swallowing studies using deep learning for landmark detection and motion analysis.
   Bandini A, Lasala A, Peladeau-Pigeon M, Dharmarathna I, et al · · 2026 · PMID 41330067 · DOI 10.1016/j.compbiomed.2025.111361