AutoVPAP Versus VPAP; Assessment of Sleep and Ventilation

ResMed

Status and phase: Completed; Phase 1

Conditions: Chest Wall Disorder; Neuromuscular Disease

Treatments: Device: AutoVPAP non-invasive ventilator; Device: VPAP non-invasive ventilator

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00252252

2005LF009B

REC Ref No 05/Q0404/001

Details and patient eligibility

About

The aim of the study is to compare the effects of a modified form (AutoVPAP) of the VPAP non-invasive ventilator versus standard VPAP ventilation on sleep quality and breathing during sleep in stable patients with nocturnal hypoventilation due to restrictive ventilatory disorders (eg. neuromuscular disease or chest wall disorder).

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 18-80 years
• Nocturnal hypoventilation (nocturnal peak transcutaneous PCO2 > 6.5 kPa when breathing spontaneously) with
• Congenital neuromuscular disease (eg. Duchenne muscular dystrophy, congenital muscular dystrophy), acquired neuromuscular disease (eg. old polio, bilateral diaphragm paralysis) or chest wall disease (eg. idiopathic scoliosis, thoracoplasty)
• Recruited from 1300 patients attending Royal Brompton Hospital Lind ward ventilator clinic.
• All patients will be familiar with non-invasive ventilation use but currently using a ventilator which is not a VPAP model eg. BiPAP Harmony, Breas PV403.
• Able to understand treatment and protocol

Exclusion criteria

• Unstable respiratory failure (PaO2 < 7.5 kPa, PaCO2 > 8.0 kPa,
• Uncontrolled heart failure or arrhythmia
• Moderate or severe bulbar weakness.
• Unable to understand treatment or protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)