Pilot Study of Efficacy of Mechanical Insufflation Exsufflation in Stroke

December 23, 2014 updated by: Sun Im, The Catholic University of Korea

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Incidence of pneumonia
Time Frame: baseline 2 weeks
baseline 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Catholic University of Korea

Investigators

  • Principal Investigator: Sun Im, The Catholic University of Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

March 5, 2014

First Submitted That Met QC Criteria

March 5, 2014

First Posted (Estimate)

March 6, 2014

Study Record Updates

Last Update Posted (Estimate)

December 24, 2014

Last Update Submitted That Met QC Criteria

December 23, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HC 13OISE0066_3
  • BCMC13AH06 (Other Identifier: Bucheon St Mary's Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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