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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04360590
Enrollment
12
Registered
2020-04-24
Start date
2011-01-01
Completion date
2014-07-30
Last updated
2021-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distress Respiratory Syndrome, Weaning Failure

Keywords

patient-ventilator interaction, pediatric acute respiratory distress syndrome, difficult weaning

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.

Interventions

DEVICEpressure support ventilation versus neurally adjusted ventilatory assist

All patients underwent three mechanical ventilation modes, lasting 1 hour each: pressure support mode, neurally adjusted ventilatory assist and again pressure support ventilation

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 2 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
asynchrony indexthree yearsin 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

MeasureTime frameDescription
patient-ventilator interactionthree yearsthe 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 )
interactionthree yearsanother 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 ventilatorthree yearsthe time of synchrony is the time during which the patient inspiratory effort and the ventilatory assistance are in phase and measured in milliseconds).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026