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

Study Overview
=================
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.

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

Conditions
-----------------
Respiratory Failure, Neuromuscular Disease, Chest Wall Disorder, Chronic Obstructive Pulmonary Disease, Obesity Hypoventilation Syndrome

Intervention / Treatment
-----------------
* Device: AutoVPAP™
* Device: VPAPIIIST-A™


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: autotitrating NIV<br>approximately 24 hours using autotitrating non-invasive ventilation for as many hours as possible whilst an inpatient in hospital | Device: AutoVPAP™<br>* 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.<br>* Other names: automatically titrating NIV;|
| Active Comparator: Standard non-invasive ventilation<br>approximately 24 hours using standard non-invasive ventilation for as many hours as possible whilst an inpatient in hospital. | Device: VPAPIIIST-A™<br>* 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.<br>* Other names: 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute exacerbation, Respiratory insufficiency, Respiratory failure, Hypercapnia, Hypoventilation, Sleep, Hypoxia, Titration, Non Invasive Ventilation