Conventional vs Neurally Adjusted Ventilatory Assist in Difficult Weaning From Mechanical Ventilation

Respiratory Failure Clinical Trial

— SENA  

Official title:

A Prospective, Randomized and Controlled Study Estimating the Neurally Adjusted Ventilatory Assist (NAVA) Versus the Pressure Support Ventilatory (PSV) in Difficult Weaning From Mechanical Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02382861
• Other study ID #: CHUBX 2012/12
• Status: Completed
• Phase: N/A
• Start date: February 20, 2015
• Est. completion date: January 2017

Study information

• Verified date: October 2018
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The NAVA, by its more physiological aspect and a better adaptation of the patient to the ventilator with a decrease of asynchronies patients-ventilators, could decrease the duration of weaning and so decrease the duration of invasive mechanical ventilation and the morbi-mortality. The objective of this study is to compare the neurally adjusted ventilatory assist versus the usual management of weaning from mechanical ventilation, in term of duration of weaning, at the patients in period of difficult weaning from the invasive mechanical ventilation.

Description:

• Background: The NAVA is a new mode of ventilation which works from the continuous recording of the electromyogram of the diaphragm. In theory, the NAVA delivred a proportional and synchronous assistance, to respiratory efforts allowing a more adequate ventilatory support. However, no study estimates the NAVA in the weaning from mechanical ventilation.

• Purpose: The NAVA, by its more physiological aspect and a better adaptation of the patient to the ventilator with a decrease of asynchronies patients-ventilators, could decrease the duration of weaning and so decrease the duration of invasive mechanical ventilation and the morbi-mortality. The objective of this study is to compare the neurally adjusted ventilatory assist versus the usual management of weaning from mechanical ventilation, in term of duration of weaning, at the patients in period of difficult weaning from the invasive mechanical ventilation.

• Detailed description: Approximately 20 to 25 % of the patients under mechanical ventilation who have the general criteria of weaning will not pass a first SBT (Spontaneous Breathing Trial). At this moment, the management of the weaning ventilatoire are made with PSV. The NAVA is proportional assistance and depends on the intensity of the electric diaphragmatic signal (Edi). The respiratory effort of the patient is directly detected from the Edi signal. In theory, the NAVA is a proportional and synchronous respiratory.

• After a first failure of a SBT, patients respecting the inclusion criteria and exlusion criteria described above are then included in the study and randomized in two groups (control group or NAVA group).

• In the control group, the PSV is decreased of 2cmH2O daily or several times a day to obtain a good clinical and biologic tolerance, with a respiratory frequency between 15 and 30/min and a tidal volume at 6ml/kg.

• In the NAVA group, the level of NAVA is daily adjusted to obtain Eadimax corresponding to 60 % of Eadimax of the patient during the SBT to obtain a good clinical and biologic tolerance, with a respiratory frequency between 15 and 30/min and a tidal volume at 6ml/kg.

• Twice a day, the criteria of SBT are looked for. When they are present, a SBT is realized. If it is a success, the patient will be extube. If it is a failure, the patient will be reventilated in PSV or NAVA according to their group. A non-invasive ventilation preventive or of "rescue" can be administered post-extubation according to criteria. The reintubated criteria are also defined.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >18 years

• Under mechanical ventilation > 48 hours

• A first failure of a SBT

• Plateau pressure 30cmH2O with tidal volume 8ml / kg

• SpO2 = in 90 % with a FiO2 = 50 %, or PaO2 / FiO2 > 150mmHg

• Positive expiratory pressure 8cmH2O

• No more of one mg/hour of noradrenaline or adrenalin

• Temperature >36 and <39°C.

• Stable neurological state (Glasgow scale > 4) without sedation (or very low sedation).

• Consent, dated and signed by the patient or his representative.

Exclusion Criteria:

• Contraindications to the NAVA (recent high digestive suture or oesophageal varices bleeding < 4 days).

• Pregnant woman.

• Age <18 years.

• Tracheotomy.

• Cardiac arrest with a reserved neurological prognostic.

• Therapeutic limitation.

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• Neurally adjusted ventilatory assist
In the NAVA group, the level of NAVA is daily adjusted to obtain Eadimax corresponding to 60 % of Eadimax of the patient during the SBT to obtain a good clinical and biologic tolerance, with a respiratory frequency between 15 and 30/min and a tidal volume at 6ml/kg.
• Noninvasive pressure support ventilation
In the control group, the PSV is decreased of 2cmH2O daily or several times a day to obtain a good clinical and biologic tolerance, with a respiratory frequency between 15 and 30/min and a tidal volume at 6ml/kg.

Locations

Country	Name	City	State
France	CHU de Bordeaux Hôpital Pellegrin	Bordeaux	Aquitaine

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of weaning from the mechanical invasive ventilation.	This duration is defined by the period between the first failure of the spontaneous breathing trial (SBT) and 48 hours after the extubation.	48 hours after the extubation
Secondary	Duration between the inclusion and the success of the SBT		28th day
Secondary	Duration of invasive mechanical ventilation		28th day
Secondary	Rate of failure of SBT		28th day
Secondary	Rate of success of SBT		28th day
Secondary	Rate of ventilator-associated pneumonia		28th day
Secondary	Length of intensive care unit stay		28th day
Secondary	Duration of hospitalization		28th day