Patient-ventilator Asynchrony During Mechanical Non-Invasive Assisted-ventilation in Pediatric Patients (NavPed-NI)

Not Applicable

Completed

• Conditions: Respiratory Failure; Mechanical Ventilation Complication
• Interventions: Other: Non-invasive Ventilation under Pressure Support; Other: Non-Invasive ventilation under NAVA

• Registration Number: NCT01238757
• Lead Sponsor: University Hospital, Geneva

Brief 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.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-11-10
• Study First Submitted QC: 2010-11-10
• Study First Posted: 2010-11-11
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-12
• Last Update Posted: 2016-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• all consecutive patients from 4 weeks to 5 years (post natal interm infants) admitted to the pediatric intensive care unit (PICU) and receiving mechanical non-invasive ventilation in pressure support ventilation

Exclusion Criteria

• Non treated pneumothorax
• Hemodynamic instability
• FiO2 > 0.6
• Poor short term prognosis (defined as a high risk of death in the next seven days)
• contraindication for gastric tube or obtention of a reliable EMGdi signal
• Known esophageal problem (hiatal hernia, esophageal varicosities)
• Active upper gastro-intestinal bleeding or any other contraindication to the insertion of a naso-gastric tube
• Neuromuscular disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Non-Invasive Pressure support	Non-invasive Ventilation under Pressure Support	in this arm, non-invasive pressure support will be recorded under 3 conditions: with the initial Expiratory Trigger Setting (ETS) with ETS +15% with ETS -15%
NAVA	Non-Invasive ventilation under NAVA	Neurally Adjusted ventilatory Assist is a ventilation mode where the ventilator is piloted by the electrical activity of the diaphragm. Ventilation is triggered and cycled off by the electrical activity of the diaphragm, the pressure delivered being proportional to this activity. The proportion named gain is chosen to obtain under NAVA the same peak pressure than during Presure Support

Primary Outcome Measures

Name	Time	Method
asynchronies	12 months	Asynchronies during mechanical ventilation are the following: Auto triggering, double triggering, late cycling, premature cycling and ineffective effort.; all ventilatory parameters are recorded under non-invasive-Pressure support (3 phases: 3 levels of expiratory trigger setting, initial, +15% and -15%, 15 min, 5 min and 5 min respectively) and NAVA (1 phase, 20 min).; Asynchronies will be determined by measuring each ventilatory cycle of all recordings.

Trial Locations

Locations (1)

University hospital of Geneva; 🇨🇭 Geneva, GE, Switzerland