Pressure Support Ventilation Versus Neurally Adjusted Ventilatory Assist in Difficult to Wean Pediatric Patients

Completed

• Conditions: Weaning Failure; Distress Respiratory Syndrome

• Registration Number: NCT04360590
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Study Timeline

• Study Start: 2011-01-01
• Primary Completion: 2014-01-31
• Study Completion: 2014-07-30
• Study First Submitted: 2020-04-18
• Study First Submitted QC: 2020-04-21
• Study First Posted: 2020-04-24
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-29
• Last Update Posted: 2021-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
asynchrony index	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 Outcome Measures

Name	Time	Method
patient-ventilator interaction	three years	the variable describing patient-ventilator interaction is the inspiratory trigger delay (defined as the time lag between the onset of neural inspiration and the onset of ventilatory assistance and measured in milliseconds )
interaction	three years	another variable describing patient-ventilator interaction is the expiratory trigger delay ( defined as the time lag between the neural expiration and the end of mechanical assistance and measured in milliseconds)
synchrony between patient and mechanical ventilator	three years	the time of synchrony is the time during which the patient inspiratory effort and the ventilatory assistance are in phase and measured in milliseconds).