Target Volume in Noninvasive Positive Pressure Ventilation (CIBLE)

AGIR à Dom

Status: Completed

Conditions: Obesity Hypoventilation Syndrome

Treatments: Device: IVAPS; Device: AVAPS

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01748656

12-AGIR-02

Details and patient eligibility

About

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

Full description

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

Enrollment: 12 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

AVAPS

Active Comparator group

Description:

AVAPS mode(BIPAP-A30-PHILIPS-RESPIRONICS)1 night

Treatment:

Device: IVAPS

IVAPS

Active Comparator group

Description:

IVAPS mode(STELAR 150-RESMED)1 night

Treatment:

Device: AVAPS