Clinical trial NCT02080988: Reflexive Coughing Force in Severe Aspirators
Official title: Cross Sectional Evaluation of Coughing Force in Stroke Patients With Severe Aspiration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: stroke
deglutition disorders
cough
aspiration pneumonia
diaphragm
respiratory function
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2014-03-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Stroke patients with dysphagia with aspiration

Brief summary: 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.

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 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

Primary outcomes:
measure: Coughing force
timeFrame: baseline one time
Secondary outcomes:
measure: Coughing force during voluntary coughing
timeFrame: baseline one time
Other outcomes:
measure: Spirometry findings (Forced vital capacity, forced expiratory volume at one second)
timeFrame: baseline one time
measure: Maximal inspiratory and expiratory pressure
timeFrame: baseline one time
measure: Root mean square values of respiratory muscles
timeFrame: baseline one time
measure: Diaphragm excursion as assessed by M mode sonography
timeFrame: baseline one time
Locations:
city: Bucheon
country: Korea, Republic of
facility: Bucheon St Mary's Hospital
Study officials:
affiliation: The Catholic University of Korea
name: Sun Im, Md PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Catholic University of Korea
name: Geun Young Park, MD PhD
role: STUDY_CHAIR
References:
citation: Choi YM, Park GY, Yoo Y, Sohn D, Jang Y, Im S. Reduced Diaphragm Excursion During Reflexive Citric Acid Cough Test in Subjects With Subacute Stroke. Respir Care. 2017 Dec;62(12):1571-1581. doi: 10.4187/respcare.05488. Epub 2017 Sep 12.