Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00479284
Status:
COMPLETED
Last Update Posted:
2007-05-28
First Post:
2007-05-25
Brief Title:
Efficacy of Average Volume Assured Pressure Support With Bi-Level Pressure Support Nocturnal Ventilation
Sponsor:
University Hospital Geneva
Organization:
University Hospital Geneva
Study Overview
Official Title:
Contribution of Average Volume Assured Pressure Support AVAPS to Efficacy of bi-Level Pressure Support Nocturnal Ventilation and Impact on Sleep Structure
Status:
COMPLETED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Marys 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 andor COPD treated and stable for at least 3 months will be included and undergo complete sleep studies in Geneva University Hospitals Sleep Laboratory Patients included must be compliant to treatment at least 4 hours of use of ventilatornight
Methods Patients are blinded as to whether or not AVAPS is implemented Target tidal volume is set at 7-8 mlkg 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
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 Marys 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 andor COPD treated and stable for at least 3 months will be included and undergo complete sleep studies in Geneva University Hospitals Sleep Laboratory Patients included must be compliant to treatment at least 4 hours of use of ventilatornight
Methods Patients are blinded as to whether or not AVAPS is implemented Target tidal volume is set at 7-8 mlkg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None