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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
History of Changes
  Purpose

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 Intervention
Nocturnal Hypoventilation
Neuromuscular Disease
Chest Wall Disorder
 Device: AutoVPAP
Device: VPAPIIIST-A

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by ResMed:

Primary Outcome Measures:
  • overnight mean oxygen saturation [ Time Frame: 4 - 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 23
Study Start Date: April 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00901485

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

No publications provided

Responsible Party: Dr Anita Simonds, Consultant in Respiratory Medicine, Royal Brompton & Harefield Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT00901485     History of Changes
Other Study ID Numbers: 08/H0708/16, R&D No. 2008/LF017B
Study First Received: January 14, 2009
Last Updated: March 21, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by ResMed:
Respiratory insufficiency
Hypercapnia
Hypoventilation
Sleep
 Polysomnography
Hypoxia
Titration
Non Invasive Ventilation

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

ClinicalTrials.gov processed this record on May 16, 2013