Reflexive Coughing Force in Severe Aspirators

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02080988
• Other study ID #: HC 13OISE0066_2
• Secondary ID: BCMC13AH06
• Status: Completed
• Phase: N/A
• First received: March 4, 2014
• Last updated: November 3, 2015
• Start date: October 2013
• Est. completion date: October 2014

Study information

• Verified date: November 2015
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Stroke

Locations

Country	Name	City	State
Korea, Republic of	Bucheon St Mary's Hospital	Bucheon

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Spirometry findings (Forced vital capacity, forced expiratory volume at one second)		baseline one time	No
Other	Maximal inspiratory and expiratory pressure		baseline one time	No
Other	Root mean square values of respiratory muscles		baseline one time	No
Other	Diaphragm excursion as assessed by M mode sonography		baseline one time	No
Primary	Coughing force	Coughing force as assessed by reflexive cough test	baseline one time	No
Secondary	Coughing force during voluntary coughing		baseline one time	No