Patient-ventilator Asynchrony During Mechanical Invasive Assisted-ventilation in Pediatric Patients (NavPed-Inv)
|ClinicalTrials.gov Identifier: NCT01193023|
Recruitment Status : Unknown
Verified August 2010 by University Hospital, Geneva.
Recruitment status was: Recruiting
First Posted : September 1, 2010
Last Update Posted : September 1, 2010
The purpose of this study is to document the prevalence and type of asynchronies incidence during invasive mechanical ventilation in pediatric patients breathing under pressure support.
And to observe the impact of adjusting the expiratory trigger setting on asynchronies, and compare these incidences with asynchronies measured in pediatric patient breathing under NAVA system (Neurally Adjusted Ventilatory Assist).
|Condition or disease||Intervention/treatment||Phase|
|Respiration, Artificial||Other: Pressure Support Device: 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 invasive ventilation and to start PSV will follow the usual practice guidelines of the unit.
Ventilation parameters in PS 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 10% below the initial set value, and will be recorded the following 5 minutes after stabilization and secondly increasing it of 10% 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 ventilation will be recorded during 20 minutes.
The 2 sessions, Pressure support and Nava, will be recorded consecutively.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Patient-ventilator Asynchrony During Mechanical Invasive Assisted-ventilation in Pediatric Patients|
|Study Start Date :||June 2010|
|Estimated Primary Completion Date :||June 2011|
|Estimated Study Completion Date :||June 2011|
Active Comparator: Pressure support
in this arm, pressure support will be recorded under 3 conditions:
Other: Pressure Support
Ventilation under pressure support
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.
Ventilation under 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 Pressure support (3 phases: 3 levels of expiratory trigger setting, initial, +10% and -10%, 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): NCT01193023
|Contact: Laurence Vignauxemail@example.com|
|Contact: Peter Rimensberger||Tél: + 41-22 37 24 firstname.lastname@example.org|
|University hospital of Geneva||Recruiting|
|Geneva, Switzerland, 1211|
|Contact: Laurence Vignaux 0041223727448 email@example.com|
|Contact: Peter Rimenberger 00412237 24 730 firstname.lastname@example.org|
|Principal Investigator: Peter Rimensberger, MD|
|Sub-Investigator: Laurence Vignaux|
|Sub-Investigator: Thomas Jaecklin, MD|
|Sub-Investigator: Serge Grazioli, MD|
|Sub-Investigator: Lise Piquilloud|
|Sub-Investigator: Philippe Jolliet, Pr|
|Sub-Investigator: Didier Tassaux, MD|
|Principal Investigator:||Peter Rimensberger, MD||Ûniversity hospital of Geneva|