Reflexive Coughing Force in Severe Aspirators

NCT ID: NCT02080988

Last Updated: 2015-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-10-31

Brief Summary

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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

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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.

Conditions

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Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Silent aspirators

Stroke patients with dysphagia with severe aspiration

No interventions assigned to this group

Non aspirating, no dysphagia group

Stroke patients with no dysphagia and no evidence of aspiration

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Catholic University of Korea

OTHER

Sponsor Role lead

Responsible Party

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Sun Im

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sun Im, Md PhD

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea

Geun Young Park, MD PhD

Role: STUDY_CHAIR

The Catholic University of Korea

Locations

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Bucheon St Mary's Hospital

Bucheon-si, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 28900040 (View on PubMed)

Other Identifiers

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BCMC13AH06

Identifier Type: OTHER

Identifier Source: secondary_id

HC 13OISE0066_2

Identifier Type: -

Identifier Source: org_study_id

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