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Autotitrating Versus Standard Non-invasive Ventilation (NIV) in Acute Exacerbation of Respiratory Failure

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ClinicalTrials.gov Identifier: NCT01174316
Recruitment Status : Unknown
Verified August 2010 by ResMed.
Recruitment status was:  Enrolling by invitation
First Posted : August 3, 2010
Last Update Posted : May 2, 2014
Sponsor:
Collaborator:
Information provided by:

Study Description
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 admitted to hospital with acute exacerbation of chronic respiratory failure.

The investigators hypothesise that autotitrating NIV will ventilate patients with acute exacerbations of chronic respiratory failure as effectively as standard NIV.


Condition or disease Intervention/treatment
Respiratory Failure Neuromuscular Disease Chest Wall Disorder Chronic Obstructive Pulmonary Disease Obesity Hypoventilation Syndrome Device: AutoVPAP™ Device: VPAPIIIST-A™

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 admitted to hospital with a sudden worsening of their existing breathing insufficiency, including an increase of carbon dioxide in the blood (hypercapnia) and acidity of the blood. Noninvasive ventilation (NIV) is standard therapy for patients with acute hypercapnic exacerbations (sudden worsening of existing breathing insufficiency) of both chronic obstructive pulmonary disease (COPD) and nonCOPD patients.

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 admitted to Royal Brompton Hospital respiratory ward 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. After 24 hours on the first NIV the patient will be swapped to the alternative NIV for a further 24 hours of treatment.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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 Acute Exacerbation of Chronic Respiratory Failure
Study Start Date : August 2010
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: autotitrating NIV
approximately 24 hours using autotitrating non-invasive ventilation for as many hours as possible whilst an inpatient in hospital
Device: AutoVPAP™
Automatically titrated non-invasive ventilator, with target gross alveolar ventilation, end expiratory positive pressure, and back up respiratory rate determined by the clinician based on height and weight. The NIV must be used for as many hours as possible over the 24 hour period but breaks for meals, physiotherapy and bathroom are allowed.
Other Names:
  • autotitrating variable positive airway pressure
  • autotitrating NIV
  • automatically titrating NIV
Active Comparator: Standard non-invasive ventilation
approximately 24 hours using standard non-invasive ventilation for as many hours as possible whilst an inpatient in hospital.
Device: VPAPIIIST-A™
Standard non-invasive ventilator, with inspiratory and expiratory positive pressure determined by the healthcare professional. The NIV must be used for as many hours as possible over the 24 hour period but breaks for meals, physiotherapy and bathroom are allowed.
Other Names:
  • standard NIV
  • standard non-invasive ventilator
  • variable positive airway pressure
  • VPAP


Outcome Measures

Primary Outcome Measures :
  1. pH at 1+ hour [ Time Frame: 1 hour ]
    pH of arterial blood after 1 hour of treatment with non-invasive ventialtion compared baseline value


Secondary Outcome Measures :
  1. pH at 4+ hours [ Time Frame: 4+ hours of NIV treatment ]
    pH of arterial blood after 4 hours of treatment with non-invasive ventialtion compared to baseline value

  2. Respiratory Rate at 1+ hour [ Time Frame: 1+ hour of NIV treatment ]
    Respiratory rate after 1 hour of treatment with non-invasive ventilation compared to baseline value

  3. Respiratory rate at 4+ hours [ Time Frame: 4+ hours of NIV treatment ]
    Respiratory rate after 4 hours of treatment with non-invasive ventilation compared to baseline value

  4. overnight mean transcutaneous carbon dioxide [ Time Frame: 24 hours ]
    mean overnight transcutaneous carbon dioxide during sleep period

  5. PaCO2 at 1+ hours [ Time Frame: 1+ hours of NIV treatment ]
    Carbon dixoide level of arterial blood after 1 hour of treatment with non-invasive ventilation compared to baseline

  6. PaCO2 at 4+ hours [ Time Frame: 4+ hours of NIV treatment ]
    Carbon dioxide level in arterial blood after 4 hours of treatment with non-invasive ventilation compared to baseline value

  7. PaO2 at 1+ hour [ Time Frame: 1+ hour of NIV treatment ]
    Oxygen level in arterial blood after 1 hour of treatment with non-invasive ventilation compared to baseline value

  8. PaO2 at 4+ hours [ Time Frame: 4+ hours of NIV treatment ]
    Oxygen level in arterial blood after 4+ hours of treatment with non-invasive ventilation compared to baseline value


Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • patients admitted or transferred to Royal Brompton Hospital with acute exacerbation of chronic respiratory failure, or inpatients who suffer a deterioration in respiratory status, defined as 7.25 < pH < 7.35, PaCO2 > 6.0kPa, and respiratory rate > 20bpm

Exclusion Criteria:

  • < 18 years old
  • pH < 7.25
  • need for immediate intubation
  • uncontrolled cardiac failure
  • hypotensive (systolic blood pressure < 90mmHg)
  • acute myocardial infarction
  • acute dysrhythmia
  • other system failure (e.g. acute renal failure, liver failure)
  • moderate or severe bulbar weakness
  • inability to understand rationale and/or consent form for study
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01174316


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

Responsible Party: Dr Anita Simonds, Consultant in Respiratory Medicine, Royal Brompton & Harefield Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT01174316     History of Changes
Other Study ID Numbers: 10/H0808/56
R&D No. 2010LF008B ( Other Identifier: Research & Development Department, RBH )
CI/2010/0027 ( Other Identifier: Medicines & Healthcare Products Regularoty Agency (devices) )
First Posted: August 3, 2010    Key Record Dates
Last Update Posted: May 2, 2014
Last Verified: August 2010

Keywords provided by ResMed:
Acute exacerbation
Respiratory insufficiency
Respiratory failure
Hypercapnia
Hypoventilation
Sleep
Hypoxia
Titration
Non Invasive Ventilation

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Insufficiency
Neuromuscular Diseases
Hypoventilation
Obesity Hypoventilation Syndrome
Respiratory Tract Diseases
Respiration Disorders
Nervous System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Obesity
Overnutrition
Nutrition Disorders