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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


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
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