Pilot Study of Efficacy of Mechanical Insufflation Exsufflation in Stroke

Not Applicable

Completed

• Conditions: Dysphagia; Stroke

• Registration Number: NCT02080806
• Lead Sponsor: The Catholic University of Korea

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.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-03-05
• Study First Submitted QC: 2014-03-05
• Study First Posted: 2014-03-06
• Primary Completion: 2014-09
• Status Verified: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-23
• Last Update Posted: 2014-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Coughing force as assessed by peak cough flow meter	baseline, 2 weeks

Secondary Outcome Measures

Name	Time	Method
Cough force during reflexive cough test	baseline, 2 weeks
Maximal inspiratory and expiratory pressure	baseline- 2 weeks

Trial Locations

Locations (1)

Bucheon St Mary's Hospital; 🇰🇷 Bucheon, Korea, Republic of