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OpenTrials
Completed

NCT Number: NCT02080988

Reflexive Coughing Force in Severe Aspirators

To assess coughing force during reflex coughing test in those with severe dysphagia and severe aspiration and compare them to than those with stroke patients with no signs of dysphagia/aspiration.

Completed

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Key information

About this study

Severe aspiration with a compromised cough function can be a risk factor of aspiration pneumonia.

Reflexive coughing can be tested by administration of citric acid via a nebulizer. The objective of this study is to measure the cough force produced via citric acid inhalation challenge, and determine if those with severe aspiration with severe dysphagia have more weak cough force during reflexive cough testing that those post-stroke patients with no signs of aspiration or dysphagia after stroke.

We also aimed to measure the strenght of the respiratory measures with the use of surface EMG.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Confirmed stroke lesions
  • Confirmed aspiration during vfss or fees examinations

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 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

Primary outcomes

  1. Coughing force

    Time frame: baseline one time

    Coughing force as assessed by reflexive cough test

Secondary outcomes

  1. Coughing force during voluntary coughing

    Time frame: baseline one time

Other outcomes

  1. Spirometry findings (Forced vital capacity, forced expiratory volume at one second)

    Time frame: baseline one time

  2. Maximal inspiratory and expiratory pressure

    Time frame: baseline one time

  3. Root mean square values of respiratory muscles

    Time frame: baseline one time

  4. Diaphragm excursion as assessed by M mode sonography

    Time frame: baseline one time

Sponsors and collaborators

Lead sponsor

The Catholic University of Korea

Other

Registry information

Official study title

Cross Sectional Evaluation of Coughing Force in Stroke Patients With Severe Aspiration

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 7, 2014
Registry last updated
Nov 5, 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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