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Target Volume in Noninvasive Positive Pressure Ventilation (CIBLE)

This study is currently recruiting participants.
Verified December 2012 by AGIR à Dom
Sponsor:
Collaborator:
ResMed
Information provided by (Responsible Party):
AGIR à Dom
ClinicalTrials.gov Identifier:
NCT01748656
First received: December 11, 2012
Last updated: February 14, 2013
Last verified: December 2012
History of Changes
  Purpose

Patients with OHS are efficiently managed with long term home-based nocturnal noninvasive positive pressure ventilation (NIPPV). Several NIPPV devices offer the feature of automatically adjusting pressure support (and/or respiratory back-up rate) on the basis of a pre-determined "ideal tidal volume" or "ideal ventilation". However algorithms used to achieve these ideal targets are different among different commercialized devices and the relative efficacy from an algorithm compared to another remains unknown. The main objective is this study is to compare two commercialized NIPPV that have this option


Condition Intervention
Obesity Hypoventilation Syndrome
 Device: IVAPS
Device: AVAPS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Two Noninvasive Positive Pressure Ventilation Devices Using Target Volume Modes in Obesity Hypoventilation Syndrome (OHS): A Pilot Randomized Crossover Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by AGIR à Dom:

Primary Outcome Measures:
  • Mean Nocturnal transcutaneous CO2 pressure (Mean nocturnal PtCO2) [ Time Frame: 1 night ] [ Designated as safety issue: No ]
    transcutaneous CO2 pressure is measured overnight. It is a reliable estimation of arterial PaCO2 to monitor nocturnal ventilation in adults with chronic respiratory failure.


Secondary Outcome Measures:
  • Mean transcutaneous CO2 pressure during REM Sleep [ Time Frame: 1 Night ] [ Designated as safety issue: No ]
  • Mean nocturnal SpO2 [ Time Frame: 1 night ] [ Designated as safety issue: No ]
  • Awake arterial PaCO2 after 1 hour of NIPPV withdrawal [ Time Frame: After 1 night ] [ Designated as safety issue: No ]
  • Micro-arousals/hour of sleep [ Time Frame: 1 night ] [ Designated as safety issue: No ]
  • Sleep Quality assess by Visual analogic scale (100mm) [ Time Frame: 1 night ] [ Designated as safety issue: No ]
  • Respiratory residual events detected by NIPPV built-in softwares [ Time Frame: 1 Night ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: January 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AVAPS
AVAPS mode(BIPAP-A30-PHILIPS-RESPIRONICS)1 night
 Device: IVAPS
IVAPS mode (RESMED Stelar 150) during 1 night
Active Comparator: IVAPS
IVAPS mode(STELAR 150-RESMED)1 night
 Device: AVAPS
AVAPS mode (PHILIPS-RESPIRONICS-A30) during 1 night

Detailed Description:

RESMED Stellar-150 (IVAPS mode)versus PHILIPS-RESPIRONICS A30 (AVAPS-mode).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with Obesity hypoventilation Syndrome (BMI≥ 30 kg/m2 and diurnal PaCO2 ≥ 45mmHg at diagnosis after exclusion of others causes of hypoventilation)
  • 18 to 75 years old
  • In stable state but treated by nocturnal NIPPV for more than 3 months and adherent to NIPPV (above 4h/night).

Exclusion Criteria:

  • patient treated with additional long term Oxygen therapy
  • Patient previously treated by AVAPS mode or IVAPS mode
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748656

Contacts
Contact: Jean Louis Pepin, MD-PHD 33476765516 JPepin@chu-grenoble.fr

Locations
France
Sleep Laboratory, Grenoble Univeristy Hospital Recruiting
Grenoble, France, 38900
Contact: Marie Peeters, MSC     33476765516     MPeeters@chu-grenoble.fr    
Sub-Investigator: Renaud Tamisier, MD PHD            
Sub-Investigator: Sandrine Launois, MD PHD            
Sub-Investigator: Patrick Levy, MD PHD            
Sponsors and Collaborators
AGIR à Dom
ResMed
Investigators
Principal Investigator: Jean Louis Pepin, MD PHD CHU Grenoble France
  More Information

No publications provided

Responsible Party: AGIR à Dom
ClinicalTrials.gov Identifier: NCT01748656     History of Changes
Other Study ID Numbers: 12-AGIR-02
Study First Received: December 11, 2012
Last Updated: February 14, 2013
Health Authority: France: Committee for the Protection of Personnes

Keywords provided by AGIR à Dom:
Noninvasive ventilation
Obesity Hypoventilation Syndrome

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

ClinicalTrials.gov processed this record on June 17, 2013