Reflexive Coughing Force in Silent Aspirators

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by The Catholic University of Korea
Sponsor:
Information provided by (Responsible Party):
Sun Im, The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT02080988
First received: March 4, 2014
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

To assess coughing force during reflex coughing test in those with dysphagia and determine if those with silent aspiration (SA)have more compromised coughing force during reflex cough testing than those with non-silent aspiration (NSA).


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 Silent 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 ]

Estimated Enrollment: 12
Study Start Date: October 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Silent aspirators
Stroke patients with dysphagia with silent aspiration
Non-silent aspirators
Stroke patients with dysphagia with positive cough response during aspiration
Normal healthy control volunteers
Healthy volunteers with no history of stroke or dysphagia

Detailed Description:

Silent aspiration (SA) can be a risk factor of aspiration pneumonia. SA has been reported to occur in over 40% of patients referred for dysphagia evaluation in a rehabilitation hospital.

Reflexive coughing can be tested by administration of citric acid via a nebulizer. The objective of this study is to measure the cough force, and determine if those with SA have more weak cough force during reflexive cough testing.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Stroke patients with aspiration

Criteria

Inclusion Criteria:

  • Confirmed stroke lesions
  • Confirmed aspiration during vfss or fees examinations
  • Confirmed presence or absence of cough during aspiration

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

Contacts
Contact: Sun Im +82-10-8733-6889 lafolia@catholic.ac.kr

Locations
Korea, Republic of
Bucheon St Mary's Hospital Recruiting
Bucheon, Korea, Republic of
Contact: Sun Im       lafolia@catholic.ac.kr   
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

No publications provided

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: March 5, 2014
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 September 29, 2014