None listed
Conditions
Brief summary
We believe that AVAPS mode of ventilation is tolerated better by patients than standard therapy. We aim to demonstrate that AVAPS is not inferior to standard pressure support ventilation when looking at clinical outcomes.
Interventions
Crossover trial design. Participants are randomised to receive either standard pressure support ventilation followed by AVAPS or AVAPS followed by standard pressure support ventilation. The comparator is standard bilevel pressure support ventilation. The intervention is the randomisation of the order AVAPS ventilation is given to the patients whilst being blinded to the mode. Automated volume assured pressure support is currently only used in patients who don't tolerate standard bilevel pressure support. AVAPS is delivered in the same way as standard pressure support ventilation - via a nasal mask, sometimes an Oro-nasal mask. AVAPS and standard pressure support ventilation both provide 2 pressures - an inspiratory pressure and an expiratory pressure. In standard therapy, these are set and don’t change throughout the night. In AVAPS a range of pressures are set and the machine alters the pressure provided according to the patient’s breathing through the night in order to achieve a targeted tidal volume. There is no washout period between modes of ventilation. The same ventilator will be used throughout, the mode will be altered. Initiation and titration of each mode of ventilation will take place at the Sydney Children's Hosptial sleep lab by and experienced sleep scientist with at least 5 years experience. Patients attend the hospital in the afternoon and undergo a titration sleep study overnight. They also perform a number of respiratory function tests on the afternoon before the titration study and the morning following the study. These take approximately 1 hour. The patient will continue on each mode of ventilation at home for 3 months. The ventilator will be used everynight throughout sleep. Adherence and actual time used is an outcome measure of the study. Adherence data will be downloaded from the machine. They will be reviewed at their standard follow up appointments. They will recieve a phone call at 1 week, 1 month and 3 months post commencement of each mode to answer questionnaires.
Sponsors
Study design
Eligibility
Inclusion criteria
Clinical evidence of need for non invasive ventilation Adherence to standard care Stable clinical status
Exclusion criteria
Acute respiratory failure Unstable haemodynamically or co-existing respiratory condition eg Cystic Fibrosis. Respiratory illness within 4 weeks of initial titration Unwilling or unable to adhere to non invasive ventilation Tracheostomy Rapidly progressive neurological disorder in which the respiratory impairment would deteriorate rapidly over 12months eg SMA type 1