Autotitrating Versus Standard Non-invasive Ventilation (NIV) in Newly Diagnosed Patients

ResMed

Status: Completed

Conditions: Chest Wall Disorder; Nocturnal Hypoventilation; Neuromuscular Disease

Treatments: Device: VPAPIIIST-A; Device: AutoVPAP

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00901485

08/H0708/16

R&D No. 2008/LF017B (Other Identifier)

Details and patient eligibility

About

The aim of the study is to compare the efficacy and tolerance of autotitrating non-invasive ventilation (NIV) versus standard NIV in patients with newly diagnosed nocturnal hypoventilation who have never experienced nocturnal, home NIV.

Full description

The aim of the study is to compare the effect of two types of noninvasive ventilator (a small machine that assists breathing) in patients newly diagnosed with nocturnal hypoventilation who are inexperienced in the use of noninvasive ventilation (NIV). NIV is standard therapy for patients with nocturnal hypoventilation.

The most common type of NIV is bilevel pressure support which assists patient breathing by delivering different levels of air pressure during inspiration and expiration via a mask covering the nose or nose and mouth. Standard bilevel NIV (VPAP™) has been further developed to create a new automatically adjusting NIV (AutoVPAP™). Automatically adjusting NIV varies the inspiratory air pressure according to the airflow rates generated by the patient. This may improve patient comfort, hours of NIV use and recovery time.

Patients over the age of 18 referred to, or under follow up at, the Royal Brompton Hospital who require domiciliary NIV but are inexperienced with use of NIV will be considered for entry into this randomised crossover study. If eligible for inclusion and willing to take part patients will be setup on automatically adjusting NIV or standard NIV, assigned in random order. At the end of one month the patient will be swapped to the alternative NIV for a further one month of domiciliary NIV treatment. At the end of each one month treatment period the patient will undergo overnight polysomnography, transcutaneous CO2 monitoring and 24 hour Holter monitoring.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• new clinical diagnosis of nocturnal hypoventilation
• requirement for long-term domiciliary non-invasive ventilation
• no previous experience with domiciliary non-invasive ventilation

Exclusion criteria

• uncontrolled cardiac failure
• acute exacerbation of respiratory failure
• daytime resting PaO2 < 7.5kPa
• moderate or severe bulbar weakness
• inability to understand rationale and/or consent form for study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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23 participants in 2 patient groups

autotitrating NIV

Experimental group

Description:

approximately 6 weeks using domiciliary nocturnal autotitrating non-invasive ventilation

Treatment:

Device: AutoVPAP

Standard non-invasive ventilation

Active Comparator group

Description:

approximately 6 weeks using domiciliary nocturnal standard non-invasive ventilation

Treatment:

Device: VPAPIIIST-A