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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Royal Brompton & Harefield NHS Foundation Trust
Information provided by:
ResMed
ClinicalTrials.gov Identifier:
NCT01174316
First received: August 2, 2010
Last updated: March 21, 2012
Last verified: August 2010
  Purpose

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 Intervention
Respiratory Failure
Neuromuscular Disease
Chest Wall Disorder
Chronic Obstructive Pulmonary Disease
Obesity Hypoventilation Syndrome
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 Acute Exacerbation of Chronic Respiratory Failure

Resource links provided by NLM:


Further study details as provided by ResMed:

Primary Outcome Measures:
  • pH at 1+ hour [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
    pH of arterial blood after 1 hour of treatment with non-invasive ventialtion compared baseline value


Secondary Outcome Measures:
  • pH at 4+ hours [ Time Frame: 4+ hours of NIV treatment ] [ Designated as safety issue: Yes ]
    pH of arterial blood after 4 hours of treatment with non-invasive ventialtion compared to baseline value

  • Respiratory Rate at 1+ hour [ Time Frame: 1+ hour of NIV treatment ] [ Designated as safety issue: Yes ]
    Respiratory rate after 1 hour of treatment with non-invasive ventilation compared to baseline value

  • Respiratory rate at 4+ hours [ Time Frame: 4+ hours of NIV treatment ] [ Designated as safety issue: Yes ]
    Respiratory rate after 4 hours of treatment with non-invasive ventilation compared to baseline value

  • overnight mean transcutaneous carbon dioxide [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    mean overnight transcutaneous carbon dioxide during sleep period

  • PaCO2 at 1+ hours [ Time Frame: 1+ hours of NIV treatment ] [ Designated as safety issue: No ]
    Carbon dixoide level of arterial blood after 1 hour of treatment with non-invasive ventilation compared to baseline

  • PaCO2 at 4+ hours [ Time Frame: 4+ hours of NIV treatment ] [ Designated as safety issue: No ]
    Carbon dioxide level in arterial blood after 4 hours of treatment with non-invasive ventilation compared to baseline value

  • PaO2 at 1+ hour [ Time Frame: 1+ hour of NIV treatment ] [ Designated as safety issue: Yes ]
    Oxygen level in arterial blood after 1 hour of treatment with non-invasive ventilation compared to baseline value

  • PaO2 at 4+ hours [ Time Frame: 4+ hours of NIV treatment ] [ Designated as safety issue: Yes ]
    Oxygen level in arterial blood after 4+ hours of treatment with non-invasive ventilation compared to baseline value


Estimated Enrollment: 20
Study Start Date: August 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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, CI/2010/0027
Study First Received: August 2, 2010
Last Updated: March 21, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

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

ClinicalTrials.gov processed this record on April 23, 2014