Patient-ventilator Asynchrony During Mechanical Non-Invasive Assisted-ventilation in Pediatric Patients (NavPed-NI) (NavPed-NI)
|ClinicalTrials.gov Identifier: NCT01238757|
Recruitment Status : Completed
First Posted : November 11, 2010
Last Update Posted : September 14, 2016
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).
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Failure Mechanical Ventilation Complication||Other: Non-invasive Ventilation under Pressure Support Other: Non-Invasive ventilation under NAVA||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Patient-ventilator Asynchrony During Mechanical Non-Invasive Assisted-ventilation in Pediatric Patients|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||September 2011|
Active Comparator: Non-Invasive 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%
Other: Non-invasive Ventilation under Pressure Support
Non-invasive Ventilation under Pressure Support:
15 min with initial settings, 5 min with ETS-%%, 5 min with ETS+10%, in random order
Active Comparator: 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
Other: Non-Invasive ventilation under NAVA
20 min session under non-invasive ventilation with NAVA
- asynchronies [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01238757
|University hospital of Geneva|
|Geneva, GE, Switzerland, 1211|
|Principal Investigator:||Peter Rimensberger, MD||University Hospital, Geneva|