Study Comparing Two Ventilation Modes NAVA (Neurally Adjusted Ventilatory Assist) Mode and Spontaneous Breathing With Inspiratory Pressure Support (IPS) Mode in Consecutive Patients Hospitalized for Acute Respiratory Failure Requiring Mechanical Ventilation With Endotracheal Tube.

Clinact

Status: Completed

Conditions: Acute Respiratory Failure

Treatments: Device: NAVA endotracheal tube

Study type: Interventional

Funder types: Other

Identifiers

NCT02018666

N° 2011-001

2011-A00559-32 (Other Identifier)

Details and patient eligibility

About

This is a multicenter, prospective, randomized, open-label study which compared two ventilation modes: spontaneous NAVA mode and spontaneous breathing with IPS mode (the latter is considered as the reference ventilatory mode) in patients admitted to the ICU for acute respiratory failure and ventilated with an endotracheal tube. NAVA mode allows to minimize patient-ventilator disharmony with acceptable tolerance and to preserve spontaneous ventilation.

Enrollment: 129 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient ventilated with endotracheal tube for more than 24 hours

• Return for at least 30 minutes to spontaneous ventilation allowing IPS with a level of pressure support <30 cm H2O;

• Level of sedation =< 4 on the Ramsay scale in the absence of medical decision to increase the level of sedation;

• Fraction of inspired oxygen (FiO 2) =< 50% with a positive end-expiratory pressure (PEEP) =< 8 cm H2O;

• Absence of administration of high-dose vasopressor therapy defined by:

  1. norepinephrine > 0.3 mcg / kg / min;
  2. dopamine > 10 mcg / kg / min;

• Estimated duration of mechanical ventilation > 48h00

Exclusion criteria

• Contraindication to the implementation of the NAVA endotracheal tube, ie any contraindication to the implementation of a gastric tube or to the repositioning of a tube already in place:

  1. Recent gastrointestinal suture ;
  2. Esophageal varices rupture with gastrointestinal bleeding within 4 days prior to inclusion;

• Therapeutic limitation or active treatment discontinuation;

• Pregnant women;

• Minors;

• Protected adults;

• Patient already included in the study;

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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129 participants in 2 patient groups

spontaneous NAVA mode

Experimental group

Treatment:

Device: NAVA endotracheal tube

Inspiratory pressure support (IPS)

Active Comparator group

Treatment:

Device: NAVA endotracheal tube