Back to resultsPilot Study of Efficacy of Mechanical Insufflation Exsufflation in Stroke
Primary Purpose
Stroke, Dysphagia
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Mechanical Insufflation Exsufflation
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, dysphagia, cough, mechanical insufflation exsufflation
Eligibility Criteria
Inclusion criteria Presence of neurogenic dysphagia Presence of impaired cough function
Exclusion criteria Episodes of acute pneumonia or diagnosis of pulmonary embolism at time of enrollment.
Previous history of chronic respiratory dysfunction or other systemic disorders that may impair respiratory function (ex,rheumatoid arthritis, chronic renal disorder, spinal cord injury) Episodes of diaphragm weakness due to peripheral polyneuropathy or phrenic nerve injury Concomitant diagnosis of myopathy, muscular dystrophy, or other neurodegenerative disorders.
Episodes of rib fracture within one year of enrollment. Chronic alcoholism Diagnosis of bullous emphysema Diagnosis of chronic renal failure
Sites / Locations
- Bucheon St Mary's Hospital
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
Mechanical insufflation exsufflation
Arm Description
Application of cough assist machine as part of the regular physiotherapy
Outcomes
Primary Outcome Measures
Coughing force as assessed by peak cough flow meter
Secondary Outcome Measures
Maximal inspiratory and expiratory pressure
Cough force during reflexive cough test
Full Information
NCT ID
NCT02080806
First Posted
March 5, 2014
Last Updated
December 23, 2014
Sponsor
The Catholic University of Korea
1. Study Identification
Unique Protocol Identification Number
NCT02080806
Brief Title
Pilot Study of Efficacy of Mechanical Insufflation Exsufflation in Stroke
Official Title
Effects of Mechanical Insufflation-exsufflation in Stroke Patients With Dysphagia - Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Stroke patients with dysphagia have restrictive lung dysfunction and impaired cough response. This pilot study was performed to determine if Mechanical Insufflation Exsufflation (MIE) therapy can help recover impaired cough function.
Detailed Description
Mechanical Insufflation- Exsufflation (MI-E) is an assisted coughing machine that has been proven to be very effective in preventing the deterioration of pulmonary function in patients with degenerative neuromuscular disorders. Impaired airway clearance in stroke patients is associated with increased incidence of aspiration pneumonia.
In this pilot study the investigators attempt to assess the efficacy of MI-E as part of a protocol for patients with dysphagia with impaired cough response.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Dysphagia
Keywords
stroke, dysphagia, cough, mechanical insufflation exsufflation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mechanical insufflation exsufflation
Arm Type
Active Comparator
Arm Description
Application of cough assist machine as part of the regular physiotherapy
Intervention Type
Device
Intervention Name(s)
Mechanical Insufflation Exsufflation
Intervention Description
Mechanical Insufflation Exsufflation -Each patient received daily treatments by means of a light-weight, elastic oronasal mask. Treatments were divided between morning and afternoon and were carried out 5 times a week. A total of 20 sessions were carried out by a a trained respiratory therapist.
Primary Outcome Measure Information:
Title
Coughing force as assessed by peak cough flow meter
Time Frame
baseline, 2 weeks
Secondary Outcome Measure Information:
Title
Maximal inspiratory and expiratory pressure
Time Frame
baseline- 2 weeks
Title
Cough force during reflexive cough test
Time Frame
baseline, 2 weeks
Other Pre-specified Outcome Measures:
Title
Incidence of pneumonia
Time Frame
baseline 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Presence of neurogenic dysphagia Presence of impaired cough function
Exclusion criteria Episodes of acute pneumonia or diagnosis of pulmonary embolism at time of enrollment.
Previous history of chronic respiratory dysfunction or other systemic disorders that may impair respiratory function (ex,rheumatoid arthritis, chronic renal disorder, spinal cord injury) Episodes of diaphragm weakness due to peripheral polyneuropathy or phrenic nerve injury Concomitant diagnosis of myopathy, muscular dystrophy, or other neurodegenerative disorders.
Episodes of rib fracture within one year of enrollment. Chronic alcoholism Diagnosis of bullous emphysema Diagnosis of chronic renal failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sun Im
Organizational Affiliation
The Catholic University of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bucheon St Mary's Hospital
City
Bucheon
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Pilot Study of Efficacy of Mechanical Insufflation Exsufflation in Stroke
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