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

This study has been completed.
Sponsor:
Collaborator:
Ligue Pulmonaire Genevoise
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00479284
First received: May 25, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  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)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Supportive Care
Official Title: Contribution of Average Volume Assured Pressure Support (AVAPS) to Efficacy of bi-Level Pressure Support Nocturnal Ventilation and Impact on Sleep Structure

Resource links provided by NLM:


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
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

No publications provided

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

Keywords provided by University Hospital, Geneva:
Non-invasive ventilation
Polysomnography
Average volume assured pressure support

Additional relevant MeSH terms:
Hypercapnia
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Obesity
Obesity Hypoventilation Syndrome
Hypoventilation
Respiratory Insufficiency
Lung Diseases, Obstructive
Signs and Symptoms, Respiratory
Signs and Symptoms
Respiratory Tract Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on April 23, 2014