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Reflexive Coughing Force in Severe Aspirators

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sun Im, The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT02080988
First received: March 4, 2014
Last updated: November 3, 2015
Last verified: November 2015
  Purpose
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.

Condition
Stroke

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Cross Sectional Evaluation of Coughing Force in Stroke Patients With Severe Aspiration

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Coughing force [ Time Frame: baseline one time ] [ Designated as safety issue: No ]
    Coughing force as assessed by reflexive cough test


Secondary Outcome Measures:
  • Coughing force during voluntary coughing [ Time Frame: baseline one time ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Spirometry findings (Forced vital capacity, forced expiratory volume at one second) [ Time Frame: baseline one time ] [ Designated as safety issue: No ]
  • Maximal inspiratory and expiratory pressure [ Time Frame: baseline one time ] [ Designated as safety issue: No ]
  • Root mean square values of respiratory muscles [ Time Frame: baseline one time ] [ Designated as safety issue: No ]
  • Diaphragm excursion as assessed by M mode sonography [ Time Frame: baseline one time ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: October 2013
Study Completion Date: October 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Silent aspirators
Stroke patients with dysphagia with severe aspiration
Non aspirating, no dysphagia group
Stroke patients with no dysphagia and no evidence of aspiration

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Stroke patients with dysphagia with aspiration
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02080988

Locations
Korea, Republic of
Bucheon St Mary's Hospital
Bucheon, Korea, Republic of
Sponsors and Collaborators
The Catholic University of Korea
Investigators
Principal Investigator: Sun Im, Md PhD The Catholic University of Korea
Study Chair: Geun Young Park, MD PhD The Catholic University of Korea
  More Information

Responsible Party: Sun Im, Assistant Professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT02080988     History of Changes
Other Study ID Numbers: HC 13OISE0066_2  BCMC13AH06 
Study First Received: March 4, 2014
Last Updated: November 3, 2015
Health Authority: South Korea: Institutional Review Board

Keywords provided by The Catholic University of Korea:
stroke
deglutition disorders
cough
aspiration pneumonia
diaphragm
respiratory function

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on December 02, 2016