Reflexive Coughing Force in Severe Aspirators

Completed

• Conditions: Stroke

• Registration Number: NCT02080988
• Lead Sponsor: The Catholic University of Korea

Brief Summary

To assess coughing force during reflex coughing test in those with severe dysphagia and severe aspiration and compare them to than those with stroke patients with no signs of dysphagia/aspiration.

Detailed Description

Severe aspiration with a compromised cough function can be a risk factor of aspiration pneumonia.

Reflexive coughing can be tested by administration of citric acid via a nebulizer. The objective of this study is to measure the cough force produced via citric acid inhalation challenge, and determine if those with severe aspiration with severe dysphagia have more weak cough force during reflexive cough testing that those post-stroke patients with no signs of aspiration or dysphagia after stroke.

We also aimed to measure the strenght of the respiratory measures with the use of surface EMG.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-03-04
• Study First Submitted QC: 2014-03-05
• Study First Posted: 2014-03-07
• Primary Completion: 2014-09
• Study Completion: 2014-10
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-03
• Last Update Posted: 2015-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Confirmed stroke lesions
• Confirmed aspiration during vfss or fees examinations

Exclusion Criteria

• Episode of acute pneumonia or pulmonary embolism at time of enrollment
• Previous history of chronic respiratory disorders or other systemic disorders that may affect respiratory function ( ex, rheumatoid disease, spinal cord injury)
• Stroke patients with multiple brain lesions
• Episode of Diaphragm weakness due to peripheral polyneuropathy or unilateral phrenic nerve palsy
• Previous episode of abdominal or thoracic surgery within one year of enrollment
• Concomitant diagnosis of myopathy, muscular dystrophy or other disorders that may affect respiratory muscles.
• Episode of rib fracture within one year of enrollment
• Chronic alcoholism
• Patient with previous diagnosis of dementia or with impaired cognitive function that may limit full participation at the evaluation
• Patient with tracheostomy state

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Coughing force	baseline one time	Coughing force as assessed by reflexive cough test

Secondary Outcome Measures

Name	Time	Method
Coughing force during voluntary coughing	baseline one time

Trial Locations

Locations (1)

Bucheon St Mary's Hospital; 🇰🇷 Bucheon, Korea, Republic of