Efficacy of Average Volume Assured Pressure Support With Bi-Level Pressure Support Nocturnal Ventilation
Primary Purpose
Chronic Hypercapnic Respiratory Failure, Obesity Hypoventilation Syndrome, Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Average volume assured pressure support (AVAPS)
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Hypercapnic Respiratory Failure focused on measuring Non-invasive ventilation, Polysomnography, Average volume assured pressure support
Eligibility 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
Sites / Locations
- Sleep Laboratory; Department of Psychiatry, Geneva University Hospital
Outcomes
Primary Outcome Measures
Quality of sleep
Efficacy of ventilation
Secondary Outcome Measures
Patient comfort
Full Information
NCT ID
NCT00479284
First Posted
May 25, 2007
Last Updated
May 25, 2007
Sponsor
University Hospital, Geneva
Collaborators
Ligue Pulmonaire Genevoise
1. Study Identification
Unique Protocol Identification Number
NCT00479284
Brief Title
Efficacy of Average Volume Assured Pressure Support With Bi-Level Pressure Support Nocturnal Ventilation
Official Title
Contribution of Average Volume Assured Pressure Support (AVAPS) to Efficacy of bi-Level Pressure Support Nocturnal Ventilation and Impact on Sleep Structure
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Geneva
Collaborators
Ligue Pulmonaire Genevoise
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hypercapnic Respiratory Failure, Obesity Hypoventilation Syndrome, Chronic Obstructive Pulmonary Disease
Keywords
Non-invasive ventilation, Polysomnography, Average volume assured pressure support
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Non-Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Average volume assured pressure support (AVAPS)
Primary Outcome Measure Information:
Title
Quality of sleep
Time Frame
One night
Title
Efficacy of ventilation
Time Frame
One night
Secondary Outcome Measure Information:
Title
Patient comfort
Time Frame
One night
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Paul Janssens, M.D.
Organizational Affiliation
Division of Lung Diseases, Department of Medicine, Geneva University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sleep Laboratory; Department of Psychiatry, Geneva University Hospital
City
Chêne-Bourg
State/Province
Geneva
ZIP/Postal Code
1225
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Average Volume Assured Pressure Support With Bi-Level Pressure Support Nocturnal Ventilation
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