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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01174316
• Other study ID #: 10/H0808/56
• Secondary ID: R&D No. 2010LF00
• Status: Withdrawn
• Phase: N/A
• Start date: August 2010
• Est. completion date: May 10, 2011

Study information

• Verified date: April 2021
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 10, 2011
• Est. primary completion date: March 1, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chest Wall Disorder
• Chronic Obstructive Pulmonary Disease
• Hypoventilation
• Lung Diseases, Obstructive
• Neuromuscular Disease
• Neuromuscular Diseases
• Obesity Hypoventilation Syndrome
• Pulmonary Disease, Chronic Obstructive
• Respiratory Failure
• Respiratory Insufficiency

Intervention

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.
• 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.

Locations

Country	Name	City	State
United Kingdom	Royal Brompton Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
ResMed	Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pH at 1+ hour	pH of arterial blood after 1 hour of treatment with non-invasive ventialtion compared baseline value	1 hour
Secondary	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
Secondary	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
Secondary	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
Secondary	overnight mean transcutaneous carbon dioxide	mean overnight transcutaneous carbon dioxide during sleep period	24 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	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