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

Not Applicable

Withdrawn

• Conditions: Chest Wall Disorder; Respiratory Failure; Neuromuscular Disease; Obesity Hypoventilation Syndrome; Chronic Obstructive Pulmonary Disease
• Interventions: Device: VPAPIIIST-A™; Device: AutoVPAP™

• Registration Number: NCT01174316
• Lead Sponsor: ResMed

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.

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 Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-02
• Study First Submitted QC: 2010-08-02
• Study First Posted: 2010-08-03
• Primary Completion: 2011-03-01
• Study Completion: 2011-05-10
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-14
• Last Update Posted: 2021-04-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard non-invasive ventilation	VPAPIIIST-A™	approximately 24 hours using standard non-invasive ventilation for as many hours as possible whilst an inpatient in hospital.
autotitrating NIV	AutoVPAP™	approximately 24 hours using autotitrating non-invasive ventilation for as many hours as possible whilst an inpatient in hospital

Primary Outcome Measures

Name	Time	Method
pH at 1+ hour	1 hour	pH of arterial blood after 1 hour of treatment with non-invasive ventialtion compared baseline value

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Royal Brompton Hospital; 🇬🇧 London, United Kingdom