Patient-ventilator Asynchrony During Mechanical Invasive Assisted-ventilation in Pediatric Patients
NavPed-Inv
1 other identifier
interventional
40
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 31, 2010
CompletedFirst Posted
Study publicly available on registry
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedSeptember 1, 2010
August 1, 2010
1 year
August 31, 2010
August 31, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
asynchronies
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.
12 months
Study Arms (2)
Pressure support
ACTIVE COMPARATORin this arm, pressure support will be recorded under 3 conditions: * with the initial Expiratory Trigger Setting (ETS) * with ETS +10% * with ETS -10%
NAVA
EXPERIMENTALNeurally 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.
Interventions
Eligibility Criteria
You may qualify if:
- all consecutive patients from 4 weeks to 12 years (post natal interm infants) admitted to the pediatric intensive care unit (PICU) and receiving mechanical ventilation in pressure support ventilation
You may not qualify if:
- Non treated pneumothorax
- Hemodynamic instability
- At least 2 hours following the admission in the PICU in post cardiac surgery
- 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
- Patients with a pacemaker
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University hospital of Geneva
Geneva, 1211, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Rimensberger, MD
Ûniversity hospital of Geneva
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 31, 2010
First Posted
September 1, 2010
Study Start
June 1, 2010
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
September 1, 2010
Record last verified: 2010-08