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

NCT ID: NCT02382861

Last Updated: 2018-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-20
• Study Completion Date: 2017-01-31

Brief 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.

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.

Conditions

Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

NAVA group

Management of the difficult weaning from mechanical ventilation by the NAVA.

Group Type: EXPERIMENTAL

Neurally adjusted ventilatory assist

Intervention Type: DEVICE

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.

Control group

Conventional management of the difficult weaning from mechanical ventilation, with the pressure ventilation.

Group Type: ACTIVE_COMPARATOR

Noninvasive pressure support ventilation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul PEREZ, Doctor

Role: STUDY_CHAIR

University Hospital, Bordeaux

Locations

CHU de Bordeaux Hôpital Pellegrin

Bordeaux, Aquitaine, France

Countries

France

Other Identifiers

CHUBX 2012/12

Identifier Type: -

Identifier Source: org_study_id