Patient-ventilator Asynchrony During Mechanical Non-Invasive Assisted-ventilation in Pediatric Patients (NavPed-NI)
Condition: Respiratory Failure; Mechanical Ventilation Complication
MeSH terms: Respiratory Insufficiency
Study type: Interventional

Summary: 
      The purpose of this study is

        -  to document the prevalence and type of asynchronies incidence during non-invasive
           mechanical ventilation in pediatric patients breathing under pressure support.

        -  to observe the impact of adjusting the expiratory trigger setting on asynchronies during
           pressure support

        -  and compare these incidences with asynchronies measured in pediatric patient breathing
           under NAVA system (Neurally Adjusted Ventilatory Assist).
    

Detailed description: 
      Two sessions will be recorded, one in PSV, one with NAVA, delivered in a random order after
      being sure the infant is calm and comfortable, according to his parents and/or the nurse in
      charge.

      Criteria for initiating non-invasive ventilation will follow the usual practice guidelines of
      the unit.

      Ventilation parameters in Non-invasive-Pressure Support will be adjusted by the clinician in
      charge of the patient, as usual based on clinical observation. Investigators will not
      interfere with ventilator settings. Ventilation will be applied via an endotracheal tube,
      uncuffed for the majority (if infant < 5 years), according to commonly applied guidelines in
      this unit.

      One 15 minutes session will be recorded, after being sure the infant is calm and comfortable
      according to the parents and/or the nurse in charge. Then the clinician in charge of the
      patient will modify the ETS, first decreasing it of 15% (absolute value)below the initial set
      value, and will be recorded the following 5 minutes after stabilization and secondly
      increasing it of 15% (absolute value)above the initial set value, and will be recorded the
      following 5 minutes after stabilization.

      NAVA will be set to deliver initially the same peak pressure (comparable level of assist)
      than during the initial PS period. Same PEEP will be delivered in both modes. This is
      possible with a pre-visualization window, allowing adjustments before switching to the NAVA
      mode. Nava non-invasive-ventilation will be recorded during 20 minutes.

      The 2 sessions, Pressure support and Nava, will be recorded consecutively.
    

Intervention name(s): Non-invasive Ventilation under Pressure Support; Non-Invasive ventilation under NAVA
Intervention type(s): Other; Other
Intervention description(s): Non-invasive Ventilation under Pressure Support:
15 min with initial settings, 5 min with ETS-%%, 5 min with ETS+10%, in random order; 20 min session under non-invasive ventilation with NAVA
Other intervention name(s): NIV-PS/initial settings; NIV-PS/ETS-10%; NIV-PS/ETS+10%; Neurally Adjusted ventilatory Assist; Neural ventilation; Diaphragmatic electrical activity ventilation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Prospective Studies; Humans, pediatric; Positive-Pressure Respiration/methods*; Respiration, Artificial/methods*; Intensive Care; Intensive Care Units/statistics & numerical data*; Respiration, Artificial/statistics & numerical data*; Patients/statistics & numerical data*; Prevalence; Respiratory Muscles/innervation; Child; Child, Preschool; Infant; Infant, Newborn; Intensive Care Units, Pediatric; Respiratory Rate*