NCT01426178

Brief Summary

Main hypothesis is that Neurally Adjusted Ventilatory Assist (NAVA) allows asynchrony reduction in non invasive ventilation (NIV) in comparison with reference Pressure Support (PSV) mode. The purpose of the protocol is to compare asynchrony rate between periods of pressure support and periods of NAVA.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 31, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

July 8, 2014

Status Verified

July 1, 2014

Enrollment Period

6 months

First QC Date

July 7, 2011

Last Update Submit

July 4, 2014

Conditions

Respiratory Insufficiency

Keywords

Respiratory InsufficiencyRespiration, ArtificialIntermittent Positive-Pressure VentilationNeurally Adjusted Ventilatory AssistNon Invasive Ventilation

Outcome Measures

Primary Outcomes (1)

  • Asynchrony rate defined as a percentage of the total respiratory rate

    at 90 minutes

Secondary Outcomes (3)

  • - Number of patients presenting a high asynchrony rate (>10%)

    at 90 minutes

  • Oxygenation evaluated as the PaO2 / FiO2 ratio at the end of considered NAVA set

    at 90 minutes

  • Patient comfort

    at 90 minutes

Interventions

Neurally Adjusted Ventilatory Assist in Non Invasive Ventilation (Device)DEVICE

After written information and consent, patients are randomised in two groups: NAVA first or PSV first. They receive a NAVA catheter, which has exactly the same appearance as a standard naso-gastric catheter.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Patient older then 18 years
  • Patient requiring first non invasive ventilation set because of acute respiratory failure

You may not qualify if:

  • Patients protected by the law
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

Related Publications (1)

  • Bertrand PM, Futier E, Coisel Y, Matecki S, Jaber S, Constantin JM. Neurally adjusted ventilatory assist vs pressure support ventilation for noninvasive ventilation during acute respiratory failure: a crossover physiologic study. Chest. 2013 Jan;143(1):30-36. doi: 10.1378/chest.12-0424.

    PMID: 22661448DERIVED

MeSH Terms

Conditions

Respiratory InsufficiencyRespiratory Aspiration

Interventions

Interactive Ventilatory SupportNoninvasive Ventilation

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Jean-Michel CONSTANTIN

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2011

First Posted

August 31, 2011

Study Start

July 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

July 8, 2014

Record last verified: 2014-07

Locations

FR(1)