Reflexive Coughing Force in Severe Aspirators
Cross Sectional Evaluation of Coughing Force in Stroke Patients With Severe Aspiration
2 other identifiers
observational
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2013
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 4, 2014
CompletedFirst Posted
Study publicly available on registry
March 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedNovember 5, 2015
November 1, 2015
11 months
March 4, 2014
November 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Coughing force
Coughing force as assessed by reflexive cough test
baseline one time
Secondary Outcomes (1)
Coughing force during voluntary coughing
baseline one time
Other Outcomes (4)
Spirometry findings (Forced vital capacity, forced expiratory volume at one second)
baseline one time
Maximal inspiratory and expiratory pressure
baseline one time
Root mean square values of respiratory muscles
baseline one time
- +1 more other outcomes
Study Arms (2)
Silent aspirators
Stroke patients with dysphagia with severe aspiration
Non aspirating, no dysphagia group
Stroke patients with no dysphagia and no evidence of aspiration
Eligibility Criteria
Stroke patients with dysphagia with aspiration
You may qualify if:
- Confirmed stroke lesions
- Confirmed aspiration during vfss or fees examinations
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bucheon St Mary's Hospital
Bucheon-si, South Korea
Related Publications (1)
Choi YM, Park GY, Yoo Y, Sohn D, Jang Y, Im S. Reduced Diaphragm Excursion During Reflexive Citric Acid Cough Test in Subjects With Subacute Stroke. Respir Care. 2017 Dec;62(12):1571-1581. doi: 10.4187/respcare.05488. Epub 2017 Sep 12.
PMID: 28900040DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sun Im, Md PhD
The Catholic University of Korea
- STUDY CHAIR
Geun Young Park, MD PhD
The Catholic University of Korea
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 4, 2014
First Posted
March 7, 2014
Study Start
October 1, 2013
Primary Completion
September 1, 2014
Study Completion
October 1, 2014
Last Updated
November 5, 2015
Record last verified: 2015-11