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
Conditions
Interventions
1. Conventional treatments, as deemed appropriate by the treating physician:
1.1. Physiotherapy
1.2. Nutritional support
1.3. Antibiotics (fever, elevated White Blood Cells [WBC])
1.4. Non-invasive p
Sponsors
Children's Hospital of Eastern Ontario (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Time (in days) to improvement in oxygenation (no longer requiring supplemental oxygen for 24 hours) 2. X-ray changes: improvement or progression (increasing atelectasis, consolidation) 3. Development of acute hypercapnic respiratory failure requiring intubation and mechanical ventilation 4. Days in intensive care unit | — |
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Canada
Outcome results
None listed