Pilot Study of Efficacy of Mechanical Insufflation Exsufflation in Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02080806
• Other study ID #: HC 13OISE0066_3
• Secondary ID: BCMC13AH06
• Status: Completed
• Phase: N/A
• First received: March 5, 2014
• Last updated: December 23, 2014
• Start date: October 2013
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Bucheon St Mary's Hospital	Bucheon

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of pneumonia		baseline 2 weeks	No
Primary	Coughing force as assessed by peak cough flow meter		baseline, 2 weeks	No
Secondary	Maximal inspiratory and expiratory pressure		baseline- 2 weeks	No
Secondary	Cough force during reflexive cough test		baseline, 2 weeks	No