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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00901485
Recruitment Status : Completed
First Posted : May 13, 2009
Last Update Posted : March 23, 2012
Royal Brompton & Harefield NHS Foundation Trust
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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.

Condition or disease Intervention/treatment Phase
Nocturnal Hypoventilation Neuromuscular Disease Chest Wall Disorder Device: AutoVPAP Device: VPAPIIIST-A Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (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
Study Start Date : April 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Arm Intervention/treatment
Experimental: autotitrating NIV
approximately 6 weeks using domiciliary nocturnal autotitrating non-invasive ventilation
Device: 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.
Other Names:
  • autotitrating variable positive airway pressure
  • autotitrating NIV
  • automatically titrating NIV
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.
Other Names:
  • standard NIV
  • standard non-invasive ventilator
  • variable positive airway pressure
  • VPAP

Primary Outcome Measures :
  1. overnight mean oxygen saturation [ Time Frame: 4 - 6 weeks ]

Secondary Outcome Measures :
  1. overnight mean transcutaneous carbon dioxide [ Time Frame: 4 - 6 weeks ]
  2. overnight peak transcutaneous carbon dioxide [ Time Frame: 4 - 6 weeks ]
  3. time spent with oxygen saturations < 90% [ Time Frame: 4 - 6 weeks ]
  4. Sleep Efficiency [ Time Frame: 4 - 6 weeks ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00901485

United Kingdom
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Principal Investigator: Anita Simonds, MD, FRCP Royal Brompton & Harefield Hospital NHS Trust

Responsible Party: Dr Anita Simonds, Consultant in Respiratory Medicine, Royal Brompton & Harefield Hospital NHS Trust Identifier: NCT00901485     History of Changes
Other Study ID Numbers: 08/H0708/16
R&D No. 2008/LF017B ( Other Identifier: Research & Development Department, RBH )
First Posted: May 13, 2009    Key Record Dates
Last Update Posted: March 23, 2012
Last Verified: January 2011

Keywords provided by ResMed:
Respiratory insufficiency
Non Invasive Ventilation

Additional relevant MeSH terms:
Neuromuscular Diseases
Nervous System Diseases
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms