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OpenTrials
Completed

NCT Number: NCT02081040

Coughing in Infratentorial Brain Lesion Patients

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bucheon St Mary's Hospital

Bucheon-si, Gyonngido, 420-717, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Not applicable (observational study with no active intervention)

Other

Primary outcomes

  1. Diaphragm excursion

    Time frame: baseline one time

    Diaphragm excursion as assessed by m mode sonography

Secondary outcomes

  1. Maximal inspiratory pressure

    Time frame: baseline one time

  2. Peak cough flow force during voluntary coughing

    Time frame: baseline one time

Other outcomes

  1. maximal expiratory pressure

    Time frame: baseline one time

  2. spirometry findings

    Time frame: baseline one time

  3. Cough force during reflexive coughing

    Time frame: baseline one time

    Peak flow force during reflexive coughing

Sponsors and collaborators

Lead sponsor

The Catholic University of Korea

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 7, 2014
Registry last updated
Feb 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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