StrokeNCT02080988
Reflexive Coughing Force in Severe Aspirators
An observational study of Stroke, run by The Catholic University of Korea at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2013to Oct 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Stroke patients with dysphagia with aspiration
Who may be able to join
- Confirmed stroke lesions
- Confirmed aspiration during vfss or fees examinations
Who cannot join
- 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.
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cross Sectional Evaluation of Coughing Force in Stroke Patients With Severe Aspiration
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.
Read the 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.
- Conditions
- Stroke
- Keywords
- stroke, deglutition disorders, cough, aspiration pneumonia, diaphragm, respiratory function
- Medical subject headings
- Stroke, Deglutition Disorders, Cough, Pneumonia, Aspiration, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Silent aspirators | Stroke patients with dysphagia with severe aspiration | |
| Non aspirating, no dysphagia group | Stroke patients with no dysphagia and no evidence of aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coughing force
Coughing force as assessed by reflexive cough test
Measured: baseline one time
Secondary outcomes (1)
Coughing force during voluntary coughing
Measured: baseline one time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startOct 2013
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Im, The Catholic University of Korea
- Investigators
- Sun Im, Md PhD, Principal investigator, The Catholic University of KoreaGeun Young Park, MD PhD, Study chair, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080988
- Sponsor's protocol ID
- HC 13OISE0066_2
- Other IDs
- BCMC13AH06
- Status last verified
- Nov 2015
- First submitted
- 4 Mar 2014
- Last updated
- 5 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28900040
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross Sectional Evaluation of Coughing Force in Stroke Patients With Severe Aspiration
- ClinicalTrials.gov ID
- NCT02080988
- Acronym / sponsor ID
- HC 13OISE0066_2
- Conditions
- Stroke
- Keywords
- stroke, deglutition disorders, cough, aspiration pneumonia, diaphragm, respiratory function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 7 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silent aspirators | – | –Stroke patients with dysphagia with severe aspiration |
| Non aspirating, no dysphagia group | – | –Stroke patients with no dysphagia and no evidence of aspiration |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients with dysphagia with aspiration
Key inclusion criteria (2 listed)
- Confirmed stroke lesions
- Confirmed aspiration during vfss or fees examinations
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Coughing force
Time frame: baseline one time
Coughing force as assessed by reflexive cough test
1 secondary outcome
Coughing force during voluntary coughing
Time frame: baseline one time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2015.
- Derived from this study: PubMed 28900040Choi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sun Im, Md PhD principal investigator
The Catholic University of Korea
Geun Young Park, MD PhD study chair
The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by The Catholic University of Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coughing force (time frame: baseline one time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02080988, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2015.