NAVASET: Nava Level Titration Using Comfort Scales

May 7, 2014 updated by: Nicolas TERZI, University Hospital, Caen

Neurally Adjusted Ventilatory Assist (NAVA) Levels Titration During Weaning Using Ventilatory Comfort Scales: a Physiological Evaluation

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14000
        • Recruiting
        • CHU de Caen
        • Contact:
        • Principal Investigator:
          • Nicolas TERZI, MD-PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Pressure Support Ventilation
Device: PSV - pressure support ventilation
Device: PSV - 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.
ACTIVE_COMPARATOR: Neurally Adjusted Ventilatory Assist
Device: Partial ventilator support with partial ventilation mode (NAVA)
Device: Neurally 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%).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of ventilatory comfort with the physiological parameters when varying the levels of pressure support and Neurally Adjusted Ventilatory Assist (NAVA)
Time Frame: 24hr
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficiency
Time Frame: 24hr
The efficiency will be evaluated by using minute ventilation
24hr
Efficiency
Time Frame: 24hr
The efficiency will be evaluated using arterial PCO2.
24hr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Collaborators

Centre d'Investigation Clinique et Technologique 805

Investigators

  • Principal Investigator: Nicolas TERZI, MD-PhD, University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (ANTICIPATED)

April 1, 2015

Study Completion (ANTICIPATED)

April 1, 2015

Study Registration Dates

First Submitted

April 30, 2014

First Submitted That Met QC Criteria

May 7, 2014

First Posted (ESTIMATE)

May 8, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

May 8, 2014

Last Update Submitted That Met QC Criteria

May 7, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-A01835-40 (OTHER: CPP Nord-Ouest III)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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