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NAVASET: Nava Level Titration Using Comfort Scales

Primary Purpose

Acute Respiratory Failure

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PSV - pressure support ventilation
Neurally Adjusted Ventilatory Assist
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Acute Respiratory Failure focused on measuring Mechanical ventilation, Acute respiratory failure, Weaning, Pressure support ventilation, Neurally adjusted ventilatory assist

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de CaenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pressure Support Ventilation

Neurally Adjusted Ventilatory Assist

Arm Description

Device: PSV - pressure support ventilation

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Efficiency
The efficiency will be evaluated by using minute ventilation
Efficiency
The efficiency will be evaluated using arterial PCO2.

Full Information

First Posted
April 30, 2014
Last Updated
May 7, 2014
Sponsor
University Hospital, Caen
Collaborators
Centre d'Investigation Clinique et Technologique 805
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1. Study Identification

Unique Protocol Identification Number
NCT02133443
Brief Title
NAVASET: Nava Level Titration Using Comfort Scales
Official Title
Neurally Adjusted Ventilatory Assist (NAVA) Levels Titration During Weaning Using Ventilatory Comfort Scales: a Physiological Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
April 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Caen
Collaborators
Centre d'Investigation Clinique et Technologique 805

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure
Keywords
Mechanical ventilation, Acute respiratory failure, Weaning, Pressure support ventilation, Neurally adjusted ventilatory assist

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pressure Support Ventilation
Arm Type
Active Comparator
Arm Description
Device: PSV - pressure support ventilation
Arm Title
Neurally Adjusted Ventilatory Assist
Arm Type
Active Comparator
Arm Description
Device: Partial ventilator support with partial ventilation mode (NAVA)
Intervention Type
Device
Intervention Name(s)
PSV - pressure support ventilation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Neurally Adjusted Ventilatory Assist
Intervention Description
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%).
Primary Outcome Measure Information:
Title
Comparison of ventilatory comfort with the physiological parameters when varying the levels of pressure support and Neurally Adjusted Ventilatory Assist (NAVA)
Description
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 Outcome Measure Information:
Title
Efficiency
Description
The efficiency will be evaluated by using minute ventilation
Time Frame
24hr
Title
Efficiency
Description
The efficiency will be evaluated using arterial PCO2.
Time Frame
24hr

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas TERZI, MD-PhD
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frédéric Lofaso, MD-PhD
Organizational Affiliation
University Hospital, Garches
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Caen
City
Caen
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas TERZI, MD-PhD
Phone
+33231064716
Email
terzi-n@chu-caen.fr
First Name & Middle Initial & Last Name & Degree
Nicolas TERZI, MD-PhD

12. IPD Sharing Statement

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NAVASET: Nava Level Titration Using Comfort Scales

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