- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00479284
Efficacy of Average Volume Assured Pressure Support With Bi-Level Pressure Support Nocturnal Ventilation
Contribution of Average Volume Assured Pressure Support (AVAPS) to Efficacy of bi-Level Pressure Support Nocturnal Ventilation and Impact on Sleep Structure
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Geneva
-
Chêne-Bourg, Geneva, Switzerland, 1225
- Sleep Laboratory; Department of Psychiatry, Geneva University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quality of sleep
Time Frame: One night
|
One night
|
Efficacy of ventilation
Time Frame: One night
|
One night
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient comfort
Time Frame: One night
|
One night
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jean-Paul Janssens, M.D., Division of Lung Diseases, Department of Medicine, Geneva University Hospital
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Respiratory Tract Diseases
- Apnea
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Lung Diseases
- Overnutrition
- Nutrition Disorders
- Signs and Symptoms, Respiratory
- Sleep Apnea Syndromes
- Obesity
- Sleep Apnea, Obstructive
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Respiratory Insufficiency
- Hypoventilation
- Obesity Hypoventilation Syndrome
Other Study ID Numbers
- Protocol 06-094
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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