Pilot Study of Efficacy of Mechanical Insufflation Exsufflation in Stroke

N/ACompletedNCT02080806

The Catholic University of Korea12 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stroke Dysphagia

Interventions

Mechanical Insufflation ExsufflationDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Bucheon St Mary's Hospital

Bucheon-si, South Korea

Outcomes

Primary Outcomes

Coughing force as assessed by peak cough flow meter

Time frame: baseline, 2 weeks

Secondary Outcomes

Maximal inspiratory and expiratory pressure

Time frame: baseline- 2 weeks

Cough force during reflexive cough test

Time frame: baseline, 2 weeks

Data from ClinicalTrials.gov

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