Patient-ventilator Asynchrony During Mechanical Invasive Assisted-ventilation in Pediatric Patients (NavPed-Inv)
Recruitment status was Recruiting
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Purpose
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 | Intervention |
|---|---|
|
Respiration, Artificial |
Other: Pressure Support Device: NAVA |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Patient-ventilator Asynchrony During Mechanical Invasive Assisted-ventilation in Pediatric Patients |
- asynchronies [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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.
| Estimated Enrollment: | 40 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Pressure support
in this arm, pressure support will be recorded under 3 conditions:
|
Other: Pressure Support
Ventilation under pressure support
|
|
Experimental: 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.
|
Device: NAVA
Ventilation under NAVA
|
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 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.
Eligibility| Ages Eligible for Study: | up to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations| Contact: Laurence Vignaux | 0041223727448 | laurence.vignaux@hcuge.ch |
| Contact: Peter Rimensberger | Tél: + 41-22 37 24 730 | peter.rimensberger@hcuge.ch |
| Switzerland | |
| University hospital of Geneva | Recruiting |
| Geneva, Switzerland, 1211 | |
| Contact: Laurence Vignaux 0041223727448 laurence.vignaux@hcuge.ch | |
| Contact: Peter Rimenberger 00412237 24 730 peter.rimensberger@hcuge.ch | |
| 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 |
More Information
No publications provided
| Responsible Party: | Dr Peter Rimensberger, neonatology and intensive care units, university hospital of Geneva |
| ClinicalTrials.gov Identifier: | NCT01193023 History of Changes |
| Other Study ID Numbers: | HUG-matped 09-253 |
| Study First Received: | August 31, 2010 |
| Last Updated: | August 31, 2010 |
| Health Authority: | Switzerland: Ethikkommission |
Keywords provided by University Hospital, Geneva:
|
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 |
ClinicalTrials.gov processed this record on May 23, 2013