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Use of Polysomnography for Non-Invasive Ventilation Settings' Optimization (NIV-OHS)
This study is currently recruiting participants.
Study NCT00603096   Information provided by Tyco Healthcare Group
First Received: January 15, 2008   No Changes Posted

January 15, 2008
January 15, 2008
June 2006
June 2008   (final data collection date for primary outcome measure)
Diurnal PaCO2 [ Time Frame: June 2008 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
 
 
 
Use of Polysomnography for Non-Invasive Ventilation Settings' Optimization
Interest of Using Nocturnal Polysomnography for Non-Invasive Ventilation (NIV) Settings' Optimization in Obesity-Hypoventilation Syndrome (OHS)

The aim of this randomized controlled trial is comparing the improvement of diurnal PaCO2 in OHS patients after one month of NIV treatment depending upon the tools used for adjusting settings. In one arm settings will be adjusted using only nocturnal oxygen SaO2 and PaCO2 at awakening whereas in the other arm patients will benefit from a complete polysomnography under NIV.

Initiation of NIV treatment implies technical adjustments (choice of mask and ventilator), but also patient education by the nurses and medical staff. The settings are generally adjusted during the daytime in awake patients. The appropriateness of these settings is generally not optimal during sleep as many respiratory events (hypopnoea, apnea, leaks, desynchronization, and glottic closure) may occur under NIV then reducing the effectiveness of treatment. These nocturnal abnormalities are routinely evaluated by measuring their consequences, i.e. oxygen desaturation and the level of PaCO2 after wake up. Some teams are now proposing to better characterize what happens when using NIV during sleep using polysomnography (PSG). The precise characterization of residual events under treatment may allow optimizing ventilator settings.

 
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Obesity-Hypoventilation Syndrome (OHS)
Device: GoodKnight 425ST - Mallinckrodt DF, Tyco Healthcare
  • Experimental: patients will benefit from a complete polysomnography under NIV
  • Active Comparator: settings will be adjusted using only nocturnal oxygen SaO2 and PaCO2 at awakening whereas
Borel JC, Roux-Lombard P, Tamisier R, Arnaud C, Monneret D, Arnol N, Baguet JP, Levy P, Pepin JL. Endothelial dysfunction and specific inflammation in obesity hypoventilation syndrome. PLoS One. 2009 Aug 24;4(8):e6733.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
45
June 2008
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient male or female, aged 20 to 75 years
  • Patient with a OHS in stable condition, with a BMI> 32 kg/m2 and a PaCO2> 6 kPa in diurnal spontaneous breathing without other cause of alveolar hypoventilation
  • Patient affiliated to a social security insurance
  • Having given its written informed consent to participate to the study

Exclusion Criteria:

  • Patients with inherent chronic obstructive pulmonary disease (COPD) with FEV1 on Forced Vital Capacity (FVC) ratio less than 70%
  • Patients suffering from heart failure with periodic breathing
  • Associated Neurological Diseases, evolving rapidly, leading to a dependency in daily activities
  • Unbalanced Psychiatric Diseases
  • Patients with a respiratory decompensation the month preceding the study
  • Patients not autonomous in the use of the NIV
  • Pacemaker patients, constituting a contraindication to magnetic stimulation
  • Sensitive subjects, in accordance with article L 1121-6 of the French Public Health Code
  • Patients with long term by steroids or other anti-inflammatory drugs
Both
20 Years to 75 Years
No
Contact: Maud Boucherie, CRA maud.boucherie@covidien.com
France
 
NCT00603096
EMEA Clinical Affairs Director, tyco Healthcare Group
38/2006/2, Ethics Comittee ref.06-TYCO-1
Tyco Healthcare Group
 
Principal Investigator: Jean-Louis pepin, Pr CHU Grenoble
Tyco Healthcare Group
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP