Skip to main content
Clinical Trials/NCT01238757
NCT01238757
Completed
N/A

Patient-ventilator Asynchrony During Mechanical Non-Invasive Assisted-ventilation in Pediatric Patients

University Hospital, Geneva1 site in 1 country7 target enrollmentJune 2010

Overview

Phase
N/A
Intervention
Not specified
Conditions
Respiratory Failure
Sponsor
University Hospital, Geneva
Enrollment
7
Locations
1
Primary Endpoint
asynchronies
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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).

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.

Registry
clinicaltrials.gov
Start Date
June 2010
End Date
September 2011
Last Updated
9 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Peter C. Rimensberger

Dr Peter Romensberger

University Hospital, Geneva

Eligibility 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

Outcomes

Primary Outcomes

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 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.

Study Sites (1)

Loading locations...

Similar Trials