Use of Polysomnography for Non-Invasive Ventilation Settings' Optimization

Obesity-Hypoventilation Syndrome (OHS) Clinical Trial

— NIV-OHS  

Official title:

Interest of Using Nocturnal Polysomnography for Non-Invasive Ventilation (NIV) Settings' Optimization in Obesity-Hypoventilation Syndrome (OHS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00603096
• Other study ID #: 38/2006/2
• Secondary ID: Ethics Comittee
• Status: Recruiting
• Phase: N/A
• First received: January 15, 2008
• Last updated: January 15, 2008
• Start date: June 2006
• Est. completion date: June 2008

Study information

• Verified date: January 2008
• Source: Tyco Healthcare Group
• Contact: Maud Boucherie, CRA
• Email: maud.boucherie[@]covidien.com
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypoventilation
• Obesity Hypoventilation Syndrome
• Obesity-Hypoventilation Syndrome (OHS)

Intervention

Device:
• GoodKnight 425ST - Mallinckrodt DF, Tyco Healthcare
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.

Locations

Country	Name	City	State
France	Laboratoire d'Explorations Fonctionnelles Cardio-Respiratoires - CHU Grenoble	Grenoble	Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
Tyco Healthcare Group

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diurnal PaCO2		June 2008	No