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

Not Applicable

Completed

Conditions: Nocturnal Hypoventilation
Neuromuscular Disease
Chest Wall Disorder

Interventions: Device: AutoVPAP
Device: VPAPIIIST-A

Registration Number: NCT00901485

Lead Sponsor: ResMed

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 23

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
autotitrating NIV	AutoVPAP	approximately 6 weeks using domiciliary nocturnal autotitrating non-invasive ventilation
Standard non-invasive ventilation	VPAPIIIST-A	approximately 6 weeks using domiciliary nocturnal standard non-invasive ventilation

Primary Outcome Measures

Name	Time	Method
Overnight Mean Oxygen Saturation	4 weeks	Overnight oximetry (SaO2) and transcutaneous capnography (PtcCO2) (TOSCA, Linde Medical Sensors, Switzerland) were performed during a sleep a on NIV at the end of each month's NIV therapy.

Secondary Outcome Measures

Name	Time	Method
Overnight Mean Transcutaneous Carbon Dioxide	4 weeks	Overnight oximetry (SaO2) and transcutaneous capnography (PtcCO2) (TOSCA, Linde Medical Sensors, Switzerland) were performed during a sleep a on NIV at the end of each month's NIV therapy.
Sleep Quality: Arousal Index	4 weeks	A full PSG was performed during a sleep a on NIV at the end of each month's NIV therapy. Standard polysomnography analysis was performed by two team members blinded to patient identity and ventilator mode (REP/JJ). Sleep quality was assessed by the Arousal Index (no of arousals/hour)
Oxygen Desaturation Index (>4%)	4 weeks	Overnight oximetry (SaO2) and transcutaneous capnography (PtcCO2) (TOSCA, Linde Medical Sensors, Switzerland) were performed during a sleep a on NIV at the end of each month's NIV therapy. ODI is the number of events per hour that SaO2 drops by \>4%.
Overnight Peak Transcutaneous Carbon Dioxide	4 weeks	Overnight oximetry (SaO2) and transcutaneous capnography (PtcCO2) (TOSCA, Linde Medical Sensors, Switzerland) were performed during a sleep a on NIV at the end of each month's NIV therapy.