NAVASET: Nava Level Titration Using Comfort Scales

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02133443

Enrollment

Registered

2014-05-08

Start date

2014-04-30

Completion date

2015-04-30

Last updated

2014-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure

Keywords

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

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).

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%).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Comparison of ventilatory comfort with the physiological parameters when varying the levels of pressure support and Neurally Adjusted Ventilatory Assist (NAVA)	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).

Secondary

Measure	Time frame	Description
Efficiency	24hr	The efficiency will be evaluated by using minute ventilation

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026