Clinical trial NCT02081040: Coughing in Infratentorial Brain Lesion Patients
Official title: Cross Sectional Observation Study of Cough Dysfunction in Infratentorial Brain Lesion Patients, as Assessed by M-mode Sonography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: brainstem
diaphragm
deglutition disorder
sonography
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2014-03-07
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Dysphagia patients due to brain lesions at a university affiliated hospital

Brief summary: 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.

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 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

Primary outcomes:
measure: Diaphragm excursion
timeFrame: baseline one time
Secondary outcomes:
measure: Maximal inspiratory pressure
timeFrame: baseline one time
measure: Peak cough flow force during voluntary coughing
timeFrame: baseline one time
Other outcomes:
measure: maximal expiratory pressure
timeFrame: baseline one time
measure: spirometry findings
timeFrame: baseline one time
measure: Cough force during reflexive coughing
timeFrame: baseline one time
Locations:
city: Bucheon
country: Korea, Republic of
facility: Bucheon St Mary's Hospital
state: Gyonngido
Study officials:
affiliation: The Catholic University of Korea
name: Sun Im, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: