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

Study Overview
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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.

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.

Official Title
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Autotitrating Non-invasive Ventilation (NIV) Versus Standard NIV; a Randomised Crossover Trial in Patients With Newly Diagnosed Hypoventilation

Conditions
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Nocturnal Hypoventilation, Neuromuscular Disease, Chest Wall Disorder

Intervention / Treatment
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* Device: AutoVPAP
* Device: VPAPIIIST-A


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: autotitrating NIV<br>approximately 6 weeks using domiciliary nocturnal autotitrating non-invasive ventilation | Device: AutoVPAP<br>* 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.<br>* Other names: automatically titrating NIV;|
| Active Comparator: Standard non-invasive ventilation<br>approximately 6 weeks using domiciliary nocturnal standard non-invasive ventilation | Device: VPAPIIIST-A<br>* Standard non-invasive ventilator with pressure and respiratory rate settings determined by healthcare professional. Nocturnal use for one month in the patient's home.<br>* Other names: VPAP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overnight Mean Oxygen Saturation | 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. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overnight Mean Transcutaneous Carbon Dioxide | 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. | 4 weeks | 
| Overnight Peak Transcutaneous Carbon Dioxide | 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. | 4 weeks | 
| Oxygen Desaturation Index (>4%) | 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%. | 4 weeks | 
| Sleep Quality: Arousal Index | 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) | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory insufficiency, Hypercapnia, Hypoventilation, Sleep, Polysomnography, Hypoxia, Titration, Non Invasive Ventilation