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Patient-ventilator Asynchrony During Mechanical Invasive Assisted-ventilation in Pediatric Patients (NavPed-Inv)

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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
Sponsor:
Information provided by:
University Hospital, Geneva

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).


Condition or disease Intervention/treatment Phase
Respiration, Artificial Other: Pressure Support Device: NAVA Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
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

Arm Intervention/treatment
Active Comparator: Pressure support

in this arm, pressure support will be recorded under 3 conditions:

  • with the initial Expiratory Trigger Setting (ETS)
  • with ETS +10%
  • with ETS -10%
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



Primary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01193023


Contacts
Contact: Laurence Vignaux 0041223727448 laurence.vignaux@hcuge.ch
Contact: Peter Rimensberger Tél: + 41-22 37 24 730 peter.rimensberger@hcuge.ch

Locations
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         
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Peter Rimensberger, MD Ûniversity hospital of Geneva

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
First Posted: September 1, 2010    Key Record Dates
Last Update Posted: September 1, 2010
Last Verified: August 2010

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