NCT02133443

Brief Summary

Determining the optimal Neurally Adjusted Ventilatory Assist (NAVA) level remains challenging, and several methods have been suggested. However none of them seems easily utilisable. Thus the investigators propose to test a way of NAVA level titration according to ventilator comfort.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2014

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 8, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

May 8, 2014

Status Verified

May 1, 2014

Enrollment Period

1 year

First QC Date

April 30, 2014

Last Update Submit

May 7, 2014

Conditions

Acute Respiratory Failure

Keywords

Mechanical ventilationAcute respiratory failureWeaningPressure support ventilationNeurally adjusted ventilatory assist

Outcome Measures

Primary Outcomes (1)

  • Comparison of ventilatory comfort with the physiological parameters when varying the levels of pressure support and Neurally Adjusted Ventilatory Assist (NAVA)

    To prove the feasibility of neurally adjusted ventilatory assist (NAVA) level titration according to the ventilatory comfort felt by the patient. The ventilatory comfort will be evaluated using the labeled visual analog scale (Banzett scale).

    24hr

Secondary Outcomes (2)

  • Efficiency

    24hr

  • Efficiency

    24hr

Study Arms (2)

Pressure Support Ventilation

ACTIVE COMPARATOR

Device: PSV - pressure support ventilation

Device: PSV - pressure support ventilation

Neurally Adjusted Ventilatory Assist

ACTIVE COMPARATOR

Device: Partial ventilator support with partial ventilation mode (NAVA)

Device: Neurally Adjusted Ventilatory Assist

Interventions

PSV - pressure support ventilationDEVICE

Gold standard partial ventilator support: Pressure Support Ventilation performed with Servo-i® ventilator (MAQUET,Critical Care, Sweden). Pressure support ventilator assistance to obtain a tidal volume of 6-8 ml/kg of ideal body weight.

Pressure Support Ventilation
Neurally Adjusted Ventilatory AssistDEVICE

Partial ventilator support partial ventilation mode (NAVA) performed with Servo-i® ventilator (Maquet,Critical Care, Sweden). Different levels of neurally adjusted ventilatory assist are tested. Stepwise implementation of the NAVA level (steps of 25% ), returning to the " optimal " level between each evaluation (PSV 100%, NAVA 100%, 75%, 50%, 125%, 150%).

Neurally Adjusted Ventilatory Assist

Eligibility Criteria

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

You may qualify if:

  • Age \> 18 years
  • Hospitalized in intensive care unit for an acute respiratory failure
  • Intubated or tracheotomized and mechanically ventilated
  • RASS score: 0;-2
  • Weaning period

You may not qualify if:

  • Hemodynamic instability
  • Absence of consent
  • Contraindication of nasogastric catheter insertion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Caen

Caen, 14000, France

RECRUITING

MeSH Terms

Interventions

Interactive Ventilatory Support

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Nicolas TERZI, MD-PhD

    University Hospital, Caen

    PRINCIPAL INVESTIGATOR

  • Frédéric Lofaso, MD-PhD

    University Hospital, Garches

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD-PhD

Study Record Dates

First Submitted

April 30, 2014

First Posted

May 8, 2014

Study Start

April 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

May 8, 2014

Record last verified: 2014-05

Locations

FR(1)