Efficacy of Average Volume Assured Pressure Support With Bi-Level Pressure Support Nocturnal Ventilation - Full Text View

Purpose

Patients with chronic hypercapnic respiratory failure can be successfully treated with home nocturnal non-invasive ventilation. Bi-level pressure support ventilators are at present the most frequently used ventilators for long term home ventilation. A recently commercialized bi-level ventilator offers the feature of automatically adjusting pressure support on the basis of a pre-determined ideal effective ventilation. Because this option may induce important swings in pressure support, and thus patient discomfort, and maybe increase leaks, we chose to analyse the impact of average volume assured pressure support (AVAPS) on patient comfort, subjective and objective quality of sleep and efficacy of ventilatory support.

Condition	Intervention
Chronic Hypercapnic Respiratory Failure Obesity Hypoventilation Syndrome Chronic Obstructive Pulmonary Disease	Procedure: Average volume assured pressure support (AVAPS)

MedlinePlus related topics:

COPD (Chronic Obstructive Pulmonary Disease) Obesity

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Non-Randomized, Single Blind, Active Control, Crossover Assignment, Safety/Efficacy Study

Official Title:	Contribution of Average Volume Assured Pressure Support (AVAPS) to Efficacy of bi-Level Pressure Support Nocturnal Ventilation and Impact on Sleep Structure

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:

Quality of sleep [ Time Frame: One night ]
Efficacy of ventilation [ Time Frame: One night ]

Secondary Outcome Measures:

Patient comfort [ Time Frame: One night ]

Enrollment:	14
Study Start Date:	June 2006
Study Completion Date:	May 2007

Detailed Description:

This study aims to compare, in a randomized order, two consecutive nights with a bi-level positive pressure ventilator (Synchrony, Respironics, USA), with and without average volume assured pressure support (AVAPS), in patients with chronic respiratory failure, treated on a long term basis by home nocturnal non-invasive ventilation.

Specific endpoints are :

quality of sleep assessed by polysomnography scored by an independent investigator (sleep efficiency, distribution of sleep stages, arousals and sleep stage changes) and subjective scores (St Mary's questionnaire),
perception of comfort of ventilation (clinical score),
efficacy of ventilation (pulsoximetry, transcutaneous capnography (Tina TCM4 Radiometer, Copenhagen), effective ventilation and tidal volumes, leaks as measured by ventilator, Stardust software, Respironics).

Patients: Fourteen patients with obesity-hypoventilation and/or COPD, treated and stable for at least 3 months, will be included and undergo complete sleep studies in Geneva University Hospital's Sleep Laboratory. Patients included must be compliant to treatment (at least 4 hours of use of ventilator/night).

Methods: Patients are blinded as to whether or not AVAPS is implemented. Target tidal volume is set at 7-8 ml/kg. EPAP (Expiratory positive airway pressure) level is unchanged. Minimal IPAP (Inspiratory positive airway pressure) level is set at usual IPAP - 3 cm H2O. Maximal IPAP is set between 25 and 30 cm H2O. Back up frequency is unchanged.

All patients must provide written informed consent. Protocol has been accepted by the ethics committee on clinical research of Geneva University Hospital.

Results of scores, and relevant parameters of polysomnography, oxymetry, and capnography, will be compared.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients treated for chronic hypercapnic respiratory failure by home bi-level positive pressure non-invasive ventilation for at least 3 months, in a stable clinical condition

Exclusion Criteria:

Poor compliance (< 4 hours/day) to home ventilation or recent episode ( < 3 months) of cardiac or respiratory failure necessitating hospitalization

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00479284

Locations


Switzerland, Geneva
	Sleep Laboratory; Department of Psychiatry, Geneva University Hospital
	Chêne-Bourg, Geneva, Switzerland, 1225

Sponsors and Collaborators

University Hospital, Geneva

Ligue Pulmonaire Genevoise

Investigators


Principal Investigator:	Jean-Paul Janssens, M.D.	Division of Lung Diseases, Department of Medicine, Geneva University Hospital

More Information

Study ID Numbers:	Protocol 06-094
First Received:	May 25, 2007
Last Updated:	May 25, 2007
ClinicalTrials.gov Identifier:	NCT00479284
Health Authority:	Switzerland: Ethikkommision

Keywords provided by University Hospital, Geneva:

Non-invasive ventilation

Polysomnography

Average volume assured pressure support

Study placed in the following topic categories:

Obesity

Sleep Apnea Syndromes

Hypercapnia

Apnea

Respiration Disorders

Sleep Apnea, Obstructive

Obesity Hypoventilation Syndrome

Hypoventilation

Dyssomnias

Sleep Disorders

Overweight

Sleep Disorders, Intrinsic

Body Weight

Signs and Symptoms

Lung Diseases, Obstructive

Respiratory Insufficiency

Respiratory Tract Diseases

Lung Diseases

Signs and Symptoms, Respiratory

Nutrition Disorders

Overnutrition

Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Pathologic Processes

Disease

Syndrome

Nervous System Diseases

ClinicalTrials.gov processed this record on October 10, 2008

Sponsors and Collaborators:	University Hospital, Geneva Ligue Pulmonaire Genevoise
Information provided by:	University Hospital, Geneva
ClinicalTrials.gov Identifier:	NCT00479284