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

Sponsor

ResMed (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01174316

Collaborator

Royal Brompton & Harefield NHS Foundation Trust (Other)

Enrollment

Location

Arms

9.3

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Failure Neuromuscular Disease Chest Wall Disorder Chronic Obstructive Pulmonary Disease Obesity Hypoventilation Syndrome	Device: AutoVPAP™ Device: VPAPIIIST-A™	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2010

Actual Primary Completion Date :

Mar 1, 2011

Actual Study Completion Date :

May 10, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: autotitrating NIV approximately 24 hours using autotitrating non-invasive ventilation for as many hours as possible whilst an inpatient in hospital	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. Other Names: autotitrating variable positive airway pressure autotitrating NIV automatically titrating NIV
Active Comparator: Standard non-invasive ventilation approximately 24 hours using standard non-invasive ventilation for as many hours as possible whilst an inpatient in hospital.	Device: 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. Other Names: standard NIV standard non-invasive ventilator variable positive airway pressure VPAP

Arm

Intervention/Treatment

Experimental: autotitrating NIV

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

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.

Other Names:

autotitrating variable positive airway pressure

autotitrating NIV

automatically titrating NIV

Active Comparator: Standard non-invasive ventilation

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

Device: 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.

Other Names:

standard NIV

standard non-invasive ventilator

variable positive airway pressure

VPAP

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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