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Pilot Study of Efficacy of Mechanical Insufflation Exsufflation in Stroke

T

The Catholic University of Korea

Status

Completed

Conditions

Dysphagia
Stroke

Treatments

Device: Mechanical Insufflation Exsufflation

Study type

Interventional

Funder types

Other

Identifiers

NCT02080806
BCMC13AH06 (Other Identifier)
HC 13OISE0066_3

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

Mechanical insufflation exsufflation
Active Comparator group
Description:
Application of cough assist machine as part of the regular physiotherapy
Treatment:
Device: Mechanical Insufflation Exsufflation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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