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

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Failure
• Intervention / Treatment: Device: Neurally adjusted ventilatory assist; Device: Noninvasive pressure support ventilation

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Aquitaine
    • Bordeaux, Aquitaine, France, 33000
      • CHU de Bordeaux Hôpital Pellegrin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NAVA group; Management of the difficult weaning from mechanical ventilation by the NAVA.	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.
Active Comparator: Control group; Conventional management of the difficult weaning from mechanical ventilation, with the pressure ventilation.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Duration between the inclusion and the success of the SBT	28th day
Duration of invasive mechanical ventilation	28th day
Rate of failure of SBT	28th day
Rate of success of SBT	28th day
Rate of ventilator-associated pneumonia	28th day
Length of intensive care unit stay	28th day
Duration of hospitalization	28th day

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Study Chair: Paul PEREZ, Doctor, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2015
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: March 3, 2015
• First Submitted That Met QC Criteria: March 6, 2015
• First Posted (Estimated): March 9, 2015

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Weaning; Extubation; Mechanical ventilation; Neurally adjusted ventilatory assist
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Therapeutics; Airway Management; Respiratory Therapy; Respiration, Artificial; Interactive Ventilatory Support
• Other Study ID Numbers: CHUBX 2012/12; 2013-A00717-38 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No