Clinical trial NCT00901485: Autotitrating Versus Standard Non-invasive Ventilation (NIV) in Newly Diagnosed Patients
Official title: Autotitrating Non-invasive Ventilation (NIV) Versus Standard NIV; a Randomised Crossover Trial in Patients With Newly Diagnosed Hypoventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nocturnal Hypoventilation
Neuromuscular Disease
Chest Wall Disorder
Keywords: Respiratory insufficiency
Hypercapnia
Hypoventilation
Sleep
Polysomnography
Hypoxia
Titration
Non Invasive Ventilation
Lead sponsor: ResMed
Sponsor class: INDUSTRY
Collaborators: name: Royal Brompton & Harefield NHS Foundation Trust
First posted: 2009-05-13
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overnight Mean Oxygen Saturation
timeFrame: 4 weeks
Secondary outcomes:
measure: Overnight Mean Transcutaneous Carbon Dioxide
timeFrame: 4 weeks
measure: Overnight Peak Transcutaneous Carbon Dioxide
timeFrame: 4 weeks
measure: Oxygen Desaturation Index (>4%)
timeFrame: 4 weeks
measure: Sleep Quality: Arousal Index
timeFrame: 4 weeks
Other outcomes:
measure: Ventilator Adherence
timeFrame: 4 weeks
measure: Median Overnight Minute Ventilation
timeFrame: 4 weeks
measure: Median Overnight Pressure Support
timeFrame: 4 weeks
measure: Median Overnight Tidal Volume
timeFrame: 4 weeks
measure: Median Overnight Respiratory Rated
timeFrame: 4 weeks
measure: Subjective Ventilator Tolerance: Comfort of Breath Delivered
timeFrame: 4 weeks
measure: Subjective Ventilator Tolerance: Ease of Falling Asleep
timeFrame: 4 weeks
measure: Subjective Ventilation Tolerance: Ease of Use of Ventilator
timeFrame: 4 weeks
measure: Subjective Ventilator Tolerance: Liked Using Ventilator
timeFrame: 4 weeks
measure: Ventilator Mode Preference
timeFrame: 4 weeks
Locations:
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
affiliation: Royal Brompton & Harefield Hospital NHS Trust
name: Anita Simonds, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
References: