Target Volume in Noninvasive Positive Pressure Ventilation | NCT01748656

Studies
Target Volume in Noninvasive Positive Pressure Ventilation

NCT01748656

Sponsor

AGIR à Dom

Status

Completed

Last Update Posted

Mar 14, 2014Estimated

Enrollment

12Actual

Phase

Not Applicable

Conditions

Obesity Hypoventilation Syndrome

Interventions

IVAPS
AVAPS

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Sep 2013Actual

Completion Date

Feb 2014Actual

First Submitted Date

Dec 11, 2012

First Submission Date that Met QC Criteria

Dec 11, 2012

First Posted Date

Dec 12, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2014

Last Update Posted Date

Mar 14, 2014Estimated

Name	Class
ResMed	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AVAPS	Active Comparator	AVAPS mode(BIPAP-A30-PHILIPS-RESPIRONICS)1 night	Device: IVAPS
IVAPS	Active Comparator	IVAPS mode(STELAR 150-RESMED)1 night	Device: AVAPS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IVAPS	Device	IVAPS mode (RESMED Stelar 150) during 1 night	AVAPS

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Mean transcutaneous CO2 pressure during REM Sleep		1 Night
Mean nocturnal SpO2		1 night
Awake arterial PaCO2 after 1 hour of NIPPV withdrawal

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean Louis Pepin, MD PHD	CHU Grenoble France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sleep Laboratory, Grenoble Univeristy Hospital		Grenoble		38900	France

Condition Browse Module

MeSH Terms

ID	Term
D010845	Obesity Hypoventilation Syndrome

Ancestor Terms

ID	Term
D020181	Sleep Apnea, Obstructive
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders

Browse Leaves

Not provided

Browse Branches

Not provided