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Pilot Study of Efficacy of Mechanical Insufflation Exsufflation in Stroke

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02080806
Enrollment
12
Registered
2014-03-06
Start date
2013-10-31
Completion date
2014-12-31
Last updated
2014-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia, Stroke

Keywords

stroke, dysphagia, cough, mechanical insufflation exsufflation

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.

Interventions

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.

Sponsors

The Catholic University of Korea
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Coughing force as assessed by peak cough flow meterbaseline, 2 weeks

Secondary

MeasureTime frame
Maximal inspiratory and expiratory pressurebaseline- 2 weeks
Cough force during reflexive cough testbaseline, 2 weeks

Other

MeasureTime frame
Incidence of pneumoniabaseline 2 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026