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

This study has been completed.
Sponsor:
Collaborator:
Royal Brompton & Harefield NHS Foundation Trust
Information provided by:
ResMed
ClinicalTrials.gov Identifier:
NCT00901485
First received: January 14, 2009
Last updated: March 21, 2012
Last verified: January 2011

January 14, 2009
March 21, 2012
April 2009
March 2011   (final data collection date for primary outcome measure)
overnight mean oxygen saturation [ Time Frame: 4 - 6 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00901485 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Autotitrating Versus Standard Non-invasive Ventilation (NIV) in Newly Diagnosed Patients
Autotitrating Non-invasive Ventilation (NIV) Versus Standard NIV; a Randomised Crossover Trial in Patients With Newly Diagnosed Hypoventilation

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Nocturnal Hypoventilation
  • Neuromuscular Disease
  • Chest Wall Disorder
  • 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
  • Device: VPAPIIIST-A
    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
  • Experimental: autotitrating NIV
    approximately 6 weeks using domiciliary nocturnal autotitrating non-invasive ventilation
    Intervention: Device: AutoVPAP
  • Active Comparator: Standard non-invasive ventilation
    approximately 6 weeks using domiciliary nocturnal standard non-invasive ventilation
    Intervention: Device: VPAPIIIST-A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
March 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00901485
08/H0708/16, R&D No. 2008/LF017B
Not Provided
Dr Anita Simonds, Consultant in Respiratory Medicine, Royal Brompton & Harefield Hospital NHS Trust
ResMed
Royal Brompton & Harefield NHS Foundation Trust
Principal Investigator: Anita Simonds, MD, FRCP Royal Brompton & Harefield Hospital NHS Trust
ResMed
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP