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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Nocturnal Hypoventilation Neuromuscular Disease Chest Wall Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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autotitrating NIV

approximately 6 weeks using domiciliary nocturnal autotitrating non-invasive ventilation

Group Type EXPERIMENTAL

AutoVPAP

Intervention Type DEVICE

Automatically titrated non-invasive ventilator, with target gross alveolar ventilation and back up respiratory rate determined by learn function. Nocturnal use for one month in patient's home.

Standard non-invasive ventilation

approximately 6 weeks using domiciliary nocturnal standard non-invasive ventilation

Group Type ACTIVE_COMPARATOR

VPAPIIIST-A

Intervention Type DEVICE

Standard non-invasive ventilator with pressure and respiratory rate settings determined by healthcare professional. Nocturnal use for one month in the patient's home.

Interventions

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AutoVPAP

Automatically titrated non-invasive ventilator, with target gross alveolar ventilation and back up respiratory rate determined by learn function. Nocturnal use for one month in patient's home.

Intervention Type DEVICE

VPAPIIIST-A

Standard non-invasive ventilator with pressure and respiratory rate settings determined by healthcare professional. Nocturnal use for one month in the patient's home.

Intervention Type DEVICE

Other Intervention Names

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autotitrating variable positive airway pressure autotitrating NIV automatically titrating NIV standard NIV standard non-invasive ventilator variable positive airway pressure VPAP

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No