NAVASET: Nava Level Titration Using Comfort Scales

Acute Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02133443
• Other study ID #: 2013-A01835-40
• Secondary ID: 2013-A01835-40
• Status: Recruiting
• Phase: N/A
• First received: April 30, 2014
• Last updated: May 7, 2014
• Start date: April 2014
• Est. completion date: April 2015

Study information

• Verified date: May 2014
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

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.
• 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%).

Locations

Country	Name	City	State
France	CHU de Caen	Caen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Caen	Centre d'Investigation Clinique et Technologique 805

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	24hr	Yes
Secondary	Efficiency	The efficiency will be evaluated by using minute ventilation	24hr	Yes
Secondary	Efficiency	The efficiency will be evaluated using arterial PCO2.	24hr	Yes