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Status unknownNCT02133443Updated May 8, 2014

NAVASET: Nava Level Titration Using Comfort Scales

An interventional study of PSV - pressure support ventilation and Neurally Adjusted Ventilatory Assist in Acute Respiratory Failure, sponsored by University Hospital, Caen. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-08.

Sponsored by University Hospital, Caen · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified May 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Physiological comparison of different levels of ventilator assistance during Neurally Adjusted Ventilatory Assist (NAVA) to evaluate the effect of these on tidal volume, inspiratoy activity, comfort scales.

We propose to evaluate the ability to guide the titration according the patient's comfort scale. The intensity of the breathing sensations will be evaluated using the labeled visual analog scale (Banzett Scale).

02

Conditions studied

  • Acute Respiratory Failure

Keywords

  • Mechanical ventilation
  • Acute respiratory failure
  • Weaning
  • Pressure support ventilation
  • Neurally adjusted ventilatory assist
03

In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's planned enrollment of 15 is below the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

University Hospital, Caen is the lead sponsor of 505 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Hemodynamic instability
  • Absence of consent
  • Contraindication of nasogastric catheter insertion
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Active comparator
    Pressure Support Ventilation

    Device: PSV - pressure support ventilation

    Device: PSV - pressure support ventilation

  • Active comparator
    Neurally Adjusted Ventilatory Assist

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

    Device: Neurally Adjusted Ventilatory Assist

Interventions

  • DevicePSV - pressure support ventilation

    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.

  • DeviceNeurally Adjusted Ventilatory Assist

    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%).

06

What researchers measure

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).

    Time frame: 24hr

Secondary outcomes

  1. Efficiency

    The efficiency will be evaluated by using minute ventilation

    Time frame: 24hr

  2. Efficiency

    The efficiency will be evaluated using arterial PCO2.

    Time frame: 24hr

07

Study locations

1 of 1 sites recruiting
  • CHU de Caen
    Caen, 14000, France
    • Nicolas TERZI, MD-PhD · Contact · terzi-n@chu-caen.fr · +33231064716
    • Nicolas TERZI, MD-PhD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02133443
Lead sponsor
University Hospital, Caen
Collaborators
Centre d'Investigation Clinique et Technologique 805
Responsible party
Nicolas TERZI (MD-PhD, University Hospital, Caen) — Principal investigator
First posted
May 8, 2014
Start date
Apr 2014
Primary completion
Apr 2015 (estimated)
Completion
Apr 2015 (estimated)
Last update
May 8, 2014

Study contacts

Nicolas TERZI, MD-PhD
principal investigator · University Hospital, Caen
Frédéric Lofaso, MD-PhD
principal investigator · University Hospital, Garches

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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