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Sponsors and Collaborators: |
University Hospital, Geneva Ligue Pulmonaire Genevoise |
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Information provided by: | University Hospital, Geneva |
ClinicalTrials.gov Identifier: | NCT00479284 |
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 |
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Chronic Hypercapnic Respiratory Failure Obesity Hypoventilation Syndrome Chronic Obstructive Pulmonary Disease |
Procedure: Average volume assured pressure support (AVAPS) |
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 |
Enrollment: | 14 |
Study Start Date: | June 2006 |
Study Completion Date: | May 2007 |
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 :
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Switzerland, Geneva | |
Sleep Laboratory; Department of Psychiatry, Geneva University Hospital | |
Chêne-Bourg, Geneva, Switzerland, 1225 |
Principal Investigator: | Jean-Paul Janssens, M.D. | Division of Lung Diseases, Department of Medicine, Geneva University Hospital |
Study ID Numbers: | Protocol 06-094 |
Study First Received: | May 25, 2007 |
Last Updated: | May 25, 2007 |
ClinicalTrials.gov Identifier: | NCT00479284 History of Changes |
Health Authority: | Switzerland: Ethikkommission |
Non-invasive ventilation Polysomnography Average volume assured pressure support |
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 |
Sleep Apnea, Obstructive Sleep Disorders Overweight Sleep Disorders, Intrinsic Body Weight Signs and Symptoms Lung Diseases, Obstructive Respiratory Insufficiency Pathologic Processes Respiratory Tract Diseases Syndrome Nutrition Disorders Signs and Symptoms, Respiratory |
Obesity Sleep Apnea Syndromes Disease Apnea Obesity Hypoventilation Syndrome Respiration Disorders Nervous System Diseases Hypoventilation Dyssomnias Lung Diseases Overnutrition Pulmonary Disease, Chronic Obstructive |