Chest Wall Disorder, Chronic Obstructive Pulmonary Disease, Neuromuscular Disease, Obesity Hypoventilation Syndrome, Respiratory Failure
Conditions
Keywords
Acute exacerbation, Respiratory insufficiency, Respiratory failure, Hypercapnia, Hypoventilation, Sleep, Hypoxia, Titration, Non Invasive Ventilation
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.
Interventions
DEVICEAutoVPAP™
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.
DEVICEVPAPIIIST-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.
Sponsors
Royal Brompton & Harefield NHS Foundation Trust
ResMed
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pH at 1+ hour | 1 hour | pH of arterial blood after 1 hour of treatment with non-invasive ventialtion compared baseline value |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Countries
United Kingdom
Outcome results
None listed