Target Volume in Noninvasive Positive Pressure Ventilation

NCT ID: NCT01748656

Last Updated: 2014-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-02-28

Brief Summary

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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

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

Conditions

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Obesity Hypoventilation Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AVAPS

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

Group Type ACTIVE_COMPARATOR

IVAPS

Intervention Type DEVICE

IVAPS mode (RESMED Stelar 150) during 1 night

IVAPS

IVAPS mode(STELAR 150-RESMED)1 night

Group Type ACTIVE_COMPARATOR

AVAPS

Intervention Type DEVICE

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

Interventions

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IVAPS

IVAPS mode (RESMED Stelar 150) during 1 night

Intervention Type DEVICE

AVAPS

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ResMed

INDUSTRY

Sponsor Role collaborator

AGIR à Dom

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean Louis Pepin, MD PHD

Role: PRINCIPAL_INVESTIGATOR

CHU Grenoble France

Locations

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Sleep Laboratory, Grenoble Univeristy Hospital

Grenoble, , France

Site Status

Countries

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France

Other Identifiers

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12-AGIR-02

Identifier Type: -

Identifier Source: org_study_id

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