NCT02382861

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2015

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 9, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

October 16, 2018

Status Verified

October 1, 2018

Enrollment Period

1.9 years

First QC Date

March 3, 2015

Last Update Submit

October 15, 2018

Conditions

Respiratory Failure

Keywords

Neurally adjusted ventilatory assistWeaningMechanical ventilationExtubation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

NAVA group

EXPERIMENTAL

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

Device: Neurally adjusted ventilatory assist

Control group

ACTIVE COMPARATOR

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

Device: Noninvasive pressure support ventilation

Interventions

Neurally adjusted ventilatory assistDEVICE

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.

NAVA group
Noninvasive pressure support ventilationDEVICE

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.

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux Hôpital Pellegrin

Bordeaux, Aquitaine, 33000, France

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Interactive Ventilatory Support

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Paul PEREZ, Doctor

    University Hospital, Bordeaux

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2015

First Posted

March 9, 2015

Study Start

February 20, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

October 16, 2018

Record last verified: 2018-10

Locations

FR(1)