Coughing in Infratentorial Brain Lesion Patients

Stroke Clinical Trial

Official title:

Cross Sectional Observation Study of Cough Dysfunction in Infratentorial Brain Lesion Patients, as Assessed by M-mode Sonography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02081040
• Other study ID #: HC 13OISE0066_1
• Status: Completed
• Phase: N/A
• First received: March 4, 2014
• Last updated: February 22, 2015
• Start date: September 2013
• Est. completion date: August 2014

Study information

• Verified date: February 2015
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Not applicable (observational study with no active intervention)

Locations

Country	Name	City	State
Korea, Republic of	Bucheon St Mary's Hospital	Bucheon	Gyonngido

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	maximal expiratory pressure		baseline one time	No
Other	spirometry findings		baseline one time	No
Other	Cough force during reflexive coughing	Peak flow force during reflexive coughing	baseline one time	No
Primary	Diaphragm excursion	Diaphragm excursion as assessed by m mode sonography	baseline one time	No
Secondary	Maximal inspiratory pressure		baseline one time	No
Secondary	Peak cough flow force during voluntary coughing		baseline one time	No