Comparison of Proportional Assist Ventilation And Neurall... | NCT02056093

Studies
Comparison of Proportional Assist Ventilation And Neurally Adjusted Ventilator Assist

NCT02056093

Sponsor

Pierre and Marie Curie University

Status

Unknown status

Last Update Posted

Feb 5, 2014Estimated

Enrollment

16Estimated

Phase

Not Applicable

Conditions

Acute Respiratory Failure

Interventions

PSV mode
PAV mode
NAVA

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

Feb 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Feb 2014Estimated

Completion Date

Feb 2014Estimated

First Submitted Date

Dec 18, 2013

First Submission Date that Met QC Criteria

Feb 4, 2014

First Posted Date

Feb 5, 2014Estimated

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

Feb 4, 2014

Last Update Posted Date

Feb 5, 2014Estimated

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

In spontaneously breathing mechanically ventilated patients, the adequacy between the patient's demand and the level of respiratory support delivered by the ventilator is a major clinical issue. Neurally adjusted ventilator assist (NAVA) and proportional assist ventilation (PAV) have been developed to adapt the level of assistance to the patient's demand. These two modes have been compared to pressure support ventilation (PSV) but have not been compared to each other.

Detailed Description

Not provided

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

16Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intubated patients	Experimental	Intubated patients: The three modes (PSV, PAV, NAVA) will be applied in random order to each mechanically ventilated patient included in the study.	Device: PSV mode Device: PAV mode Device: NAVA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PSV mode	Device	Application of PSV in all patients	Intubated patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Breathing pattern variability	The coefficient of variation (standard deviation divided by the mean) of the tidal volume (expressed in %)	February 2014

Secondary Outcomes

Measure	Description	Time Frame
Patient-ventilator asynchrony	Prevalence of ineffective efforts and double triggering (expressed as a number of events per minute)	February, 2014

Other Outcomes

Measure	Description	Time Frame
Electrical diaphragm activity Gas exchange	measured by the NAVA probe	February 2014

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Intubated patients.
Mechanical ventilation for a respiratory reason.
Expected duration of Mechanical ventilation > 48 hrs.
Spontaneous breathing.
Sedations stopped for more than 24 hours.

Exclusion Criteria:

- Main contra indications to NAVA: gastro-oesophageal surgery in the previous 12 months, oesophageal obstruction, gastro-esophageal bleeding in the previous 30 days, history of esophageal varices, facial trauma or surgery, neuromuscular diseases, individuals with known or suspected phrenic nerve dysfunction.
Main contra indications to PAV: airway leak, body weight <25 kg, neuromuscular diseases.
Hemodynamic instability defined as the current administration of vasopressors or inotropic drugs.
Severe hypoxemia defined as PaO2/FiO2 ratio <200.
Decision to withhold life-sustaining treatment.
Pregnant women.
Minors < 18 years.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matthieu SCHMIDT, MD	Association pour le Développement et l'Organisation de la Recherche en Pneumologie	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Pneumologie et de Reanimation médicale, Groupe hospitalier Pitie Salpetriere	Recruiting	Paris	Île-de-France Region	75013	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25879592	Derived	Schmidt M, Kindler F, Cecchini J, Poitou T, Morawiec E, Persichini R, Similowski T, Demoule A. Neurally adjusted ventilatory assist and proportional assist ventilation both improve patient-ventilator interaction. Crit Care. 2015 Feb 25;19(1):56. doi: 10.1186/s13054-015-0763-6.