ClinicalTrials.Veeva

Menu

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.

C

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)

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

Trial contacts and locations

11

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems