Pilot Study of Efficacy of Mechanical Insufflation Exsufflation in Stroke

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Mechanical Insufflation-exsufflation in Stroke Patients With Dysphagia - Pilot Study

Conditions
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Stroke, Dysphagia

Intervention / Treatment
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* Device: Mechanical Insufflation Exsufflation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mechanical insufflation exsufflation<br>Application of cough assist machine as part of the regular physiotherapy | Device: Mechanical Insufflation Exsufflation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coughing force as assessed by peak cough flow meter |  | baseline, 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal inspiratory and expiratory pressure |  | baseline- 2 weeks | 
| Cough force during reflexive cough test |  | baseline, 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, dysphagia, cough, mechanical insufflation exsufflation