Clinical trial NCT04360590: Pressure Support Ventilation Versus Neurally Adjusted Ventilatory Assist in Difficult to Wean Pediatric Patients
Official title: Pressure Support Ventilation (PSV) Versus Neurally Adjusted Ventilatory Assist (NAVA) in Difficult to Wean Pediatric ARDS Patients: a Physiologic Crossover Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Distress Respiratory Syndrome
Weaning Failure
Keywords: patient-ventilator interaction
pediatric acute respiratory distress syndrome
difficult weaning
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 12
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: during the study, all patients (older than 1 month and younger than 2 years) admitted to Pediatric Intensive Care Unit for moderate pediatric Acute Respiratory Distress Syndrome and ready for weaning from mechanical ventilation were evaluated.

All patients who failed up to 3 SBTs taking less than 7 days, presenting at least two of the following signs: diaphoresis, nasal flaring, tachycardia (Heart Rate increase ≥ 40 bpm) cardiac arrhythmias, hypotension, apnea, PETCO2 increase \> 10 mmHg, decrease of arterial pH \< 7.32, PaO2 \< 60mmHg with an FiO2 ≥ 0.40 (PaO2/FiO2 less than 150), were enrolled in the study.

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.

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

Primary outcomes:
measure: asynchrony index
timeFrame: three years
Secondary outcomes:
measure: patient-ventilator interaction
timeFrame: three years
measure: interaction
timeFrame: three years
measure: synchrony between patient and mechanical ventilator
timeFrame: three years
Other outcomes:
Locations:
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Giorgio P Conti, Prof
role: STUDY_DIRECTOR
References:
citation: Blanch L, Villagra A, Sales B, Montanya J, Lucangelo U, Lujan M, Garcia-Esquirol O, Chacon E, Estruga A, Oliva JC, Hernandez-Abadia A, Albaiceta GM, Fernandez-Mondejar E, Fernandez R, Lopez-Aguilar J, Villar J, Murias G, Kacmarek RM. Asynchronies during mechanical ventilation are associated with mortality. Intensive Care Med. 2015 Apr;41(4):633-41. doi: 10.1007/s00134-015-3692-6. Epub 2015 Feb 19.
citation: Blokpoel RG, Burgerhof JG, Markhorst DG, Kneyber MC. Patient-Ventilator Asynchrony During Assisted Ventilation in Children. Pediatr Crit Care Med. 2016 May;17(5):e204-11. doi: 10.1097/PCC.0000000000000669.
citation: Thille AW, Rodriguez P, Cabello B, Lellouche F, Brochard L. Patient-ventilator asynchrony during assisted mechanical ventilation. Intensive Care Med. 2006 Oct;32(10):1515-22. doi: 10.1007/s00134-006-0301-8. Epub 2006 Aug 1.
citation: Bordessoule A, Emeriaud G, Morneau S, Jouvet P, Beck J. Neurally adjusted ventilatory assist improves patient-ventilator interaction in infants as compared with conventional ventilation. Pediatr Res. 2012 Aug;72(2):194-202. doi: 10.1038/pr.2012.64.
citation: Breatnach C, Conlon NP, Stack M, Healy M, O'Hare BP. A prospective crossover comparison of neurally adjusted ventilatory assist and pressure-support ventilation in a pediatric and neonatal intensive care unit population. Pediatr Crit Care Med. 2010 Jan;11(1):7-11. doi: 10.1097/PCC.0b013e3181b0630f.
citation: Pediatric Acute Lung Injury Consensus Conference Group. Pediatric acute respiratory distress syndrome: consensus recommendations from the Pediatric Acute Lung Injury Consensus Conference. Pediatr Crit Care Med. 2015 Jun;16(5):428-39. doi: 10.1097/PCC.0000000000000350.
citation: Spinazzola G, Costa R, De Luca D, Chidini G, Ferrone G, Piastra M, Conti G. Pressure Support Ventilation (PSV) versus Neurally Adjusted Ventilatory Assist (NAVA) in difficult to wean pediatric ARDS patients: a physiologic crossover study. BMC Pediatr. 2020 Jul 7;20(1):334. doi: 10.1186/s12887-020-02227-1.