Target Volume Mode Controlled Ventilator in Obesity Hypoventilation Syndrome

Overview

The purpose of this study is to investigate the evolution of daytime partial pressure of carbon dioxide in the blood (PaCO2) after 6 weeks of noninvasive ventilation-pressure support ventilation (NIV-PSV) with target volume versus continuous positive airway pressure (CPAP) alone versus NIV-PSV.

Full Title of Study: “Target Volume With a Pressure Controlled Ventilator in Obesity Hypoventilation Syndrome With Persistent Oxygen Desaturations With Continuous Positive Airway Pressure”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: May 2012

Detailed Description

Compare the efficacy between 3 ventilation modes (CPAP, PSV and PSV with Target Volume) on patients with obesity hypoventilation syndrome already treated with CPAP but with persistent desaturations.

Interventions

  • Device: Breas Vivo 40
    • The Vivo 40 will be used either in CPAP mode, PSV mode without Target Volume or PSV mode with Target Volume

Arms, Groups and Cohorts

  • Active Comparator: NIV-PSV without Target Volume
    • Pressure Support Non Invasive Ventilation without Target Volume
  • Active Comparator: NIV-PSV with Target Volume
    • Non Invasive Pressure Support Ventilation with Target Volume set
  • Active Comparator: NIV-CPAP
    • Pressure Support Ventilation in CPAP mode

Clinical Trial Outcome Measures

Primary Measures

  • Evolution of daytime PaCO2 of NIV without target volume, with Target volume and with CPAP alone
    • Time Frame: 6 weeks

Secondary Measures

  • Evolution in dyspnea scores (BDI/TDI and Simon Score)
    • Time Frame: 6 weeks
  • Evolution of subjective and objective sleepness (Osler)
    • Time Frame: 6 weeks
  • Cardiovascular parameters on Arterial strength (pulse velocity) and Endothelial function (Post ischemic test)
    • Time Frame: 6 weeks
  • Evolution of blood inflammation (IL6, TNFα et CRP)
    • Time Frame: 6 weeks
  • Evolution of insulin résistance
    • Time Frame: 6 weeks
  • Compliance (hours of treatment)
    • Time Frame: 6 weeks
  • Evolution of quality of ventilation (Leaks, asynchronism, others events)
    • Time Frame: 6 weeks
  • Sleep quality (PSG) between the 3 groups at 6 weeks
    • Time Frame: 6 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Patients from 20 to 75 years old. – Body mass index > 32 kg/m2 – Nocturnal oxygen desaturation 5 mn ≤ 88% under CPAP, – PaCO2 > 5,9 kPa in diurnal, spontaneous ventilation Exclusion Criteria:

  • Patients with COPD and VEMS/FVC < 65% – Patients with CHF and periodic breathing (Ejection Fraction <40%) – Patients with a recent respiratory decompensation in the month preceding inclusion

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Breas Medical S.A.R.L.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jean-Louis Pepin, prof, Principal Investigator, University Hospital, Grenoble

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