- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02081040
Coughing in Infratentorial Brain Lesion Patients
Cross Sectional Observation Study of Cough Dysfunction in Infratentorial Brain Lesion Patients, as Assessed by M-mode Sonography
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Our previous work has shown that stroke patients with dysphagia have impaired diaphragm excursion in comparison to those with no dysphagia. It has been postulated that respiratory and cough function are primarily controlled by respiratory and swallowing centers located in the brainstem.We postulated that those with infratentorial brain lesions would have more impaired cough and respiratory function than those with non-brainstem lesions and supratentorial brain lesions.
However there has been no studies whether those with infratentorial brain lesions have more impaired cough function and decreased diaphragm excursion than those with supratentorial brain lesions.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Gyonngido
-
Bucheon, Gyonngido, Korea, Republic of, 420-717
- Bucheon St Mary's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Group 1- Brainstem lesion subjects with dysphagia that would require insertion of a nasogastric tube Group 2- Non-brainstem lesion subjects with dysphagia that would require insertion of a nasogastric tube Group 3- Stroke patients with no evidence of dysphagia
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 arthritis, chronic renal 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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Infratentorial dysphagia patients
Infratentorial brain lesion patients with confirmed evidence of dysphagia
|
|
|
Supratentorial dysphagia patients
Supratentorial brain lesions\ patients with confirmed evidence of dysphagia
|
|
|
Brain lesion patients without dysphagia
Brain lesion patients with no evidence of dysphagia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diaphragm excursion
Time Frame: baseline one time
|
Diaphragm excursion as assessed by m mode sonography
|
baseline one time
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Maximal inspiratory pressure
Time Frame: baseline one time
|
baseline one time
|
|
Peak cough flow force during voluntary coughing
Time Frame: baseline one time
|
baseline one time
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
maximal expiratory pressure
Time Frame: baseline one time
|
baseline one time
|
|
|
spirometry findings
Time Frame: baseline one time
|
baseline one time
|
|
|
Cough force during reflexive coughing
Time Frame: baseline one time
|
Peak flow force during reflexive coughing
|
baseline one time
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sun Im, MD PhD, The Catholic University of Korea
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HC 13OISE0066_1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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