Clinical trial NCT01238757: Patient-ventilator Asynchrony During Mechanical Non-Invasive Assisted-ventilation in Pediatric Patients (NavPed-NI)
Official title: Patient-ventilator Asynchrony During Mechanical Non-Invasive Assisted-ventilation in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Mechanical Ventilation Complication
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*
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2010-11-11
Enrollment: 7
Sex: ALL
Minimum age (years): 4
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: asynchronies
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University hospital of Geneva
state: GE
Study officials:
affiliation: University Hospital, Geneva
name: Peter Rimensberger, MD
role: PRINCIPAL_INVESTIGATOR
References: