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

Autotitrating Non-invasive Ventilation (NIV) Versus Standard NIV; a Randomised Crossover Trial in Patients With Acute Exacerbation of Chronic Respiratory Failure

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.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Obstructive Pulmonary Disease; Respiratory Failure; Obesity Hypoventilation Syndrome; Neuromuscular Disease; Chest Wall Disorder
• Intervention / Treatment: 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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW3 6NP
    • Royal Brompton Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pH at 1+ hour	pH of arterial blood after 1 hour of treatment with non-invasive ventialtion compared baseline value	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pH at 4+ hours	pH of arterial blood after 4 hours of treatment with non-invasive ventialtion compared to baseline value	4+ hours of NIV treatment
Respiratory Rate at 1+ hour	Respiratory rate after 1 hour of treatment with non-invasive ventilation compared to baseline value	1+ hour of NIV treatment
Respiratory rate at 4+ hours	Respiratory rate after 4 hours of treatment with non-invasive ventilation compared to baseline value	4+ hours of NIV treatment
overnight mean transcutaneous carbon dioxide	mean overnight transcutaneous carbon dioxide during sleep period	24 hours
PaCO2 at 1+ hours	Carbon dixoide level of arterial blood after 1 hour of treatment with non-invasive ventilation compared to baseline	1+ hours of NIV treatment
PaCO2 at 4+ hours	Carbon dioxide level in arterial blood after 4 hours of treatment with non-invasive ventilation compared to baseline value	4+ hours of NIV treatment
PaO2 at 1+ hour	Oxygen level in arterial blood after 1 hour of treatment with non-invasive ventilation compared to baseline value	1+ hour of NIV treatment
PaO2 at 4+ hours	Oxygen level in arterial blood after 4+ hours of treatment with non-invasive ventilation compared to baseline value	4+ hours of NIV treatment

Collaborators and Investigators

• Sponsor: ResMed
• Collaborators: Royal Brompton & Harefield NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): May 10, 2011

Study Registration Dates

• First Submitted: August 2, 2010
• First Submitted That Met QC Criteria: August 2, 2010
• First Posted (Estimate): August 3, 2010

Study Record Updates

• Last Update Posted (Actual): April 19, 2021
• Last Update Submitted That Met QC Criteria: April 14, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Sleep; Hypoxia; Acute exacerbation; Respiratory failure; Hypercapnia; Hypoventilation; Titration; Respiratory insufficiency; Non Invasive Ventilation
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Lung Diseases; Overnutrition; Nutrition Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Obesity; Sleep Apnea, Obstructive; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency; Hypoventilation; Obesity Hypoventilation Syndrome; Neuromuscular Diseases
• 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))