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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by University Hospital, Geneva.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01238757
First received: November 10, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
  Purpose

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 Intervention
Respiration
Artificial
 Other: Non-invasive Ventilation under Pressure Support
Other: Non-Invasive ventilation under 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 Non-Invasive Assisted-ventilation in Pediatric Patients

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • 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 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.



Estimated Enrollment: 20
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: 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

Other Names:
  • NIV-PS/initial settings
  • NIV-PS/ETS-10%
  • NIV-PS/ETS+10%
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.
 Other: Non-Invasive ventilation under NAVA
20 min session under non-invasive ventilation with NAVA
Other Names:
  • Neurally Adjusted ventilatory Assist
  • Neural ventilation
  • Diaphragmatic electrical activity ventilation

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 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.

  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all consecutive patients from 4 weeks to 5 years (post natal interm infants) admitted to the pediatric intensive care unit (PICU) and receiving mechanical non-invasive ventilation in pressure support ventilation

Exclusion Criteria:

  • Non treated pneumothorax
  • Hemodynamic instability
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01238757

Contacts
Contact: Laurence Vignaux, MSC +33665247942 laurence.vignaux@hotmail.fr
Contact: Peter Rimensberger, MD +41223224730 peter.rimensberger@hcuge.ch

Locations
Switzerland
University hospital of Geneva Recruiting
Geneva, GE, Switzerland, 1211
Contact: Laurence Vignaux, MSC     +3365247942     laurence.vignaux@hotmail.fr    
Contact: Peter Rimensberger, MD     +41 22 3724730     peter.rimensberger@hcuge.ch    
Principal Investigator: Peter Rimensberger, MD            
Sub-Investigator: Laurence Vignaux, MSC            
Sub-Investigator: Thomas Jaecklin, MD MSC            
Sub-Investigator: Serge Grazioli, MD            
Sub-Investigator: Lise Piquilloud            
Sub-Investigator: Didier Tassaux, MD            
Sub-Investigator: Philippe Jolliet, Pr            
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Peter Rimensberger, MD University Hospital, Geneva
  More Information

No publications provided

Responsible Party: Dr Peter Rimensberger, neonatology and intensive care units, university hospital of Geneva
ClinicalTrials.gov Identifier: NCT01238757     History of Changes
Other Study ID Numbers: HUG-matped 09-054
Study First Received: November 10, 2010
Last Updated: November 10, 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
Child
Child, Preschool
Infant
Infant, Newborn
Intensive Care Units, Pediatric
Respiratory Rate*

ClinicalTrials.gov processed this record on May 16, 2013