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

ResMed

Status: Withdrawn

Conditions: Respiratory Failure; Chest Wall Disorder; Chronic Obstructive Pulmonary Disease; Neuromuscular Disease; Obesity Hypoventilation Syndrome

Treatments: Device: AutoVPAP™; Device: VPAPIIIST-A™

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01174316

CI/2010/0027 (Other Identifier)

R&D No. 2010LF008B (Other Identifier)

10/H0808/56

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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0 participants in 2 patient groups

autotitrating NIV

Experimental group

Description:

approximately 24 hours using autotitrating non-invasive ventilation for as many hours as possible whilst an inpatient in hospital

Treatment:

Device: AutoVPAP™

Standard non-invasive ventilation

Active Comparator group

Description:

approximately 24 hours using standard non-invasive ventilation for as many hours as possible whilst an inpatient in hospital.

Treatment:

Device: VPAPIIIST-A™