NAVASET: Nava Level Titration Using Comfort Scales

Not Applicable

• Conditions: Acute Respiratory Failure
• Interventions: Device: PSV - pressure support ventilation; Device: Neurally Adjusted Ventilatory Assist

• Registration Number: NCT02133443
• Lead Sponsor: University Hospital, Caen

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).

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-30
• Status Verified: 2014-05
• Study First Submitted QC: 2014-05-07
• Last Update Submitted: 2014-05-07
• Study First Posted: 2014-05-08
• Last Update Posted: 2014-05-08
• Primary Completion: 2015-04
• Study Completion: 2015-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pressure Support Ventilation	PSV - pressure support ventilation	Device: PSV - pressure support ventilation
Neurally Adjusted Ventilatory Assist	Neurally Adjusted Ventilatory Assist	Device: Partial ventilator support with partial ventilation mode (NAVA)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Efficiency	24hr	The efficiency will be evaluated using arterial PCO2.

Trial Locations

Locations (1)

CHU de Caen; 🇫🇷 Caen, France