Use of Polysomnography for Non-Invasive Ventilation Settings' Optimization (NIV-OHS)

Tyco Healthcare Group

Status

Unknown

Conditions

Obesity-Hypoventilation Syndrome (OHS)

Treatments

Device: GoodKnight 425ST - Mallinckrodt DF, Tyco Healthcare

Study type

Interventional

Funder types

Industry

Identifiers

NCT00603096

Ethics Comittee ref.06-TYCO-1

38/2006/2

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 estimated patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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