Target Volume in Noninvasive Positive Pressure Ventilation

Comparison of Two Noninvasive Positive Pressure Ventilation Devices Using Target Volume Modes in Obesity Hypoventilation Syndrome (OHS): A Pilot Randomized Crossover Controlled Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01748656

Acronym

CIBLE

Enrollment

Registered

2012-12-12

Start date

2013-01-31

Completion date

2014-02-28

Last updated

2014-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity Hypoventilation Syndrome

Keywords

Noninvasive ventilation, Obesity Hypoventilation Syndrome

Brief summary

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

Detailed description

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

Interventions

DEVICEIVAPS

IVAPS mode (RESMED Stelar 150) during 1 night

DEVICEAVAPS

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Mean Nocturnal transcutaneous CO2 pressure (Mean nocturnal PtCO2)	1 night	transcutaneous CO2 pressure is measured overnight. It is a reliable estimation of arterial PaCO2 to monitor nocturnal ventilation in adults with chronic respiratory failure.

Secondary

Measure	Time frame
Micro-arousals/hour of sleep	1 night
Sleep Quality assess by Visual analogic scale (100mm)	1 night
Awake arterial PaCO2 after 1 hour of NIPPV withdrawal	After 1 night
Mean nocturnal SpO2	1 night
Respiratory residual events detected by NIPPV built-in softwares	1 Night
Mean transcutaneous CO2 pressure during REM Sleep	1 Night

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026