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Clinical Trials/NCT04360590
NCT04360590
Completed
N/A

Pressure Support Ventilation (PSV) Versus Neurally Adjusted Ventilatory Assist (NAVA) in Difficult to Wean Pediatric ARDS Patients: a Physiologic Crossover Study

Fondazione Policlinico Universitario Agostino Gemelli IRCCS0 sites12 target enrollmentJanuary 1, 2011

Overview

Phase
N/A
Intervention
Not specified
Conditions
Distress Respiratory Syndrome
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Enrollment
12
Primary Endpoint
asynchrony index
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

This study assessed the effects of NAVA versus Pressure Support Ventilation (PSV) on patient-ventilator interaction in pediatric patients with difficult weaning from mechanical ventilation after moderate Pediatric Acute Respiratory Distress Syndrome (PARDS).

Detailed Description

12 pediatric patients, admitted in Pediatric Intensive Care Unit (PICU) with moderate PARDS and who failed up to 3 SBTs in less than 7 days, were enrolled in this study. These patients underwent three studies conditions, lasting 1 hour each: Pressure support ventilation 1, Neurally adjusted ventilatory assist and Pressure support ventilation 2. During each trial were recorded the patient tracings of flow, airway pressure and electrical activity of diaphragm for the patient-ventilator interaction analysis.

Registry
clinicaltrials.gov
Start Date
January 1, 2011
End Date
July 30, 2014
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

SPINAZZOLA GIORGIA

Medical doctor, specialist in Anesthesia and Intensive Care Medicine

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Eligibility Criteria

Inclusion Criteria

  • diagnosis of moderate PARDS
  • 3 spontaneous breathing trials failed in less than 7 days

Exclusion Criteria

  • hemodynamic instability
  • severe respiratory instability
  • contraindication to nasogastric tube exchange
  • increase in intracranial pressure
  • palliative care for end-stage oncologic disease
  • neuromuscular disease
  • lesions of medulla

Outcomes

Primary Outcomes

asynchrony index

Time Frame: three years

in each study condition, the asynchrony index was measured. The asynchrnony index value grater than 10% is an indicator of worsening patient-ventilator interaction. the Asynchrony Index is the ratio between the number of asynchronous events and the total respiratory rate, expressed as percentage

Secondary Outcomes

  • patient-ventilator interaction(three years)
  • interaction(three years)
  • synchrony between patient and mechanical ventilator(three years)

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