Impact of In-exsufflator Treatment on hospitalisation for Respiratory Exacerbation in Neuromuscular Disease

Completed

Conditions: Children with neuromuscular disorders who are admitted to hospital with a respiratory deterioration (hypoxemia and/or the presence of new onset radiologically proven atelectasis or consolidation).
Nervous System Diseases
Neuromuscular disorders

Registration Number: ISRCTN21996121

Lead Sponsor: Children's Hospital of Eastern Ontario (Canada)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 128

Inclusion Criteria

1. Patients aged 3 to 17 years
2. Patients have a known neuromotor disorder affecting respiratory muscles
3. Admitted to hospital with a respiratory deterioration (hypoxemia in the presence of new onset radiologically proven atelectasis or consolidation)

Exclusion Criteria

1. Refusal to participate
2. Already using the Emerson in-exsufflator at home on a regular basis
3. Development of new uncompensated hypercapnic respiratory failure requiring intubation and mechanical ventilation
4. History of bullous emphysema, known susceptibility to pneumothorax or pneumomediastinum, or known to have had any recent barotraumas

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to discharge: an estimate of the primary end-point, time to discharge with standard care, was based on the clinical experience of the principal investigators and is currently being verified with a three-year retrospective chart review at Childrens Hospital of Eastern Ontario (CHEO). The mean length of stay in these patients is estimated to be 10 days. Discussions with several paediatric respirologists have taken place, focusing on what magnitude of difference in time to discharge would be clinically important between treatment and control groups. The consensus was a Minimally Clinically Important Difference (MCID) of three days' reduction from the average current length of stay in the study population. These numbers translate to a hazard ratio of 1.4. A two-sided time-to-event test at a = 0.05 will be used to detect a significant difference in time to discharge between the two arms.

Secondary Outcome Measures

Name	Time	Method
1. Time (in days) to improvement in oxygenation (no longer requiring supplemental oxygen for 24 hours)<br>2. X-ray changes: improvement or progression (increasing atelectasis, consolidation)<br>3. Development of acute hypercapnic respiratory failure requiring intubation and mechanical ventilation<br>4. Days in intensive care unit