Autotitrating Versus Standard Non-invasive Ventilation (NIV) in Newly Diagnosed Patients
Chest Wall Disorder
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Autotitrating Non-invasive Ventilation (NIV) Versus Standard NIV; a Randomised Crossover Trial in Patients With Newly Diagnosed Hypoventilation|
- overnight mean oxygen saturation [ Time Frame: 4 - 6 weeks ] [ Designated as safety issue: Yes ]
- overnight mean transcutaneous carbon dioxide [ Time Frame: 4 - 6 weeks ] [ Designated as safety issue: No ]
- overnight peak transcutaneous carbon dioxide [ Time Frame: 4 - 6 weeks ] [ Designated as safety issue: No ]
- time spent with oxygen saturations < 90% [ Time Frame: 4 - 6 weeks ] [ Designated as safety issue: Yes ]
- Sleep Efficiency [ Time Frame: 4 - 6 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Experimental: autotitrating NIV
approximately 6 weeks using domiciliary nocturnal autotitrating non-invasive ventilation
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.
Active Comparator: Standard non-invasive ventilation
approximately 6 weeks using domiciliary nocturnal standard non-invasive ventilation
Standard non-invasive ventilator with pressure and respiratory rate settings determined by healthcare professional. Nocturnal use for one month in the patient's home.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00901485
|Royal Brompton Hospital|
|London, United Kingdom, SW3 6NP|
|Principal Investigator:||Anita Simonds, MD, FRCP||Royal Brompton & Harefield Hospital NHS Trust|