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Coughing in Infratentorial Brain Lesion Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02081040
First Posted: March 7, 2014
Last Update Posted: February 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sun Im, The Catholic University of Korea
  Purpose
To record diaphragm excursion in infratentorial brain lesions patients with dysphagia during coughing and compare them to those with supratentorial brain lesion patients with dysphasia and those with no dysphagia at a university affiliated rehabilitation department.

Condition Intervention
Stroke Other: Not applicable (observational study with no active intervention)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Cross Sectional Observation Study of Cough Dysfunction in Infratentorial Brain Lesion Patients, as Assessed by M-mode Sonography

Resource links provided by NLM:


Further study details as provided by Sun Im, The Catholic University of Korea:

Primary Outcome Measures:
  • Diaphragm excursion [ Time Frame: baseline one time ]
    Diaphragm excursion as assessed by m mode sonography


Secondary Outcome Measures:
  • Maximal inspiratory pressure [ Time Frame: baseline one time ]
  • Peak cough flow force during voluntary coughing [ Time Frame: baseline one time ]

Other Outcome Measures:
  • maximal expiratory pressure [ Time Frame: baseline one time ]
  • spirometry findings [ Time Frame: baseline one time ]
  • Cough force during reflexive coughing [ Time Frame: baseline one time ]
    Peak flow force during reflexive coughing


Enrollment: 42
Study Start Date: September 2013
Study Completion Date: August 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Other: Not applicable (observational study with no active intervention)

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.

  Eligibility

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Dysphagia patients due to brain lesions at a university affiliated hospital
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02081040


Locations
Korea, Republic of
Bucheon St Mary's Hospital
Bucheon, Gyonngido, Korea, Republic of, 420-717
Sponsors and Collaborators
The Catholic University of Korea
Investigators
Principal Investigator: Sun Im, MD PhD The Catholic University of Korea
  More Information

Responsible Party: Sun Im, Assistant Professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT02081040     History of Changes
Other Study ID Numbers: HC 13OISE0066_1
First Submitted: March 4, 2014
First Posted: March 7, 2014
Last Update Posted: February 24, 2015
Last Verified: February 2015

Keywords provided by Sun Im, The Catholic University of Korea:
brainstem
diaphragm
deglutition disorder
sonography