Clinical trial NCT04792788: NAVA vs PSV Ventilation During Weaning From Mechanical Ventilation in Children After Liver Transplantation
Official title: The Use of Neurally Adjusted Ventilator Assist Versus Pressure Support Ventilation durIng weaninG From Mechanical ventilAtion in pediaTric Patients After livEr Transplantation. A Physiologic Cross-over Controlled Trial. NAVIGATE Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pediatric Liver Transplantation
Weaning From Mechanical Ventilation
Keywords: mechanical ventilation
liver transplantation
pediatric
neurally adjusted ventilatory assist
weaning
pressure support ventilation
Lead sponsor: Bambino Gesù Hospital and Research Institute
Sponsor class: OTHER
Collaborators: name: Catholic University of the Sacred Heart
First posted: 2021-03-11
Enrollment: 12
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Liver transplantation is the treatment of choice for acute and chronic end-stage liver disease. Neurally Adjusted Ventilator Assist (NAVA) may be a feasible solution to guide the liberation from mechanical ventilation reducing asynchronies between patient and ventilator, and optimizing ventilator cycling. Cardiovascular and respiratory effects during NAVA ventilation are very limited after major abdominal surgery. The purpose of this application is to explore the efficacy of NAVA to reduce the asynchronies between the ventilator and pediatric patient admitted in Pediatric Intensive Care Unit (PICU) after major abdominal surgery, and the relationship between an optimal level of NAVA and cardiac and pulmonary function.

Detailed description: Twelve pediatric patients underwent liver transplantation and admitted during postoperative period in PICU will be studied. They will be endotracheally intubated and spontaneously triggering the mechanical ventilator. In each patient enrolled a specially manufactured nasogastric tube will be inserted. This nasogastric tube is equipped with ten electrodes. The correct position of the nasogastric tube (and of electrodes) will be confirmed checking the good quality of Edi trace with the P waves displayed by the central electrodes on monitor of Servo I Ventilator (Maquet). All the patients will be ventilated using ventilators with NAVA option (Servo-I, Maquet Critical Care, Sweden). After a stabilization period in Pressure Support Ventilation (PSV) according with the attending physician, each patient will be studied for a duration of 2 hours, divided in three trials of 40-minutes (first 30 minutes to washout from the effects of previous ventilation mode and during the last 10 minutes the results will be recorded). Each patient will be randomized for ventilation mode sequence (PSV/NAVA/PSV or NAVA/PSV/NAVA). The patient tracings of flow, airway pressure, electrical activity of diaphragm for the patient-ventilator interaction analysis, blood gas analysis and cardiovascular parameters will be recorded during each trial.

Eligibility criteria: Inclusion Criteria:

* Liver recipients (from cadaveric or living donor)
* Invasive Mechanical ventilation

Exclusion Criteria:

* Neurological impairment
* Neuromuscular, mitochondrial, metabolic, or chromosomal diseases with baby hypotonia
* Lesions of medulla
* Hemodynamic instability requiring inotropes/vasopressors (dopamine \> 6 mcg/kg/min, norepinephrine, epinephrine, dobutamine, milrinone) or volume load.
* Congenital cardiovascular disease
* Patient extubated
* Need of controlled mechanical ventilation
* Intravenous infusion of benzodiazepines or propofol
* Pneumonia, pneumothorax, massive pleural effusion
* Patient placed on extracorporeal circuit
* Contraindications to insert nasogastric tube
* Not expected to survive beyond 24 hours
* Parental/legal guardian refusal

Primary outcomes:
measure: Asynchrony Index
timeFrame: last 10 minutes of each ventilatory trial, NAVA or PSV
measure: Left and right ventricle function
timeFrame: last 10 minutes of each ventilatory trial, NAVA or PSV
Secondary outcomes:
measure: arterial partial pressure of oxygen (PaO2)
timeFrame: last 10 minutes of each ventilatory trial, NAVA or PSV
measure: arterial partial pressure of carbon dioxide
timeFrame: last 10 minutes of each ventilatory trial, NAVA or PSV
measure: oxygen index
timeFrame: last 10 minutes of each ventilatory trial, NAVA or PSV
measure: respiratory rate
timeFrame: last 10 minutes of each ventilatory trial, NAVA or PSV
measure: lactate
timeFrame: last 10 minutes of each ventilatory trial, NAVA or PSV
measure: heart rate
timeFrame: last 10 minutes of each ventilatory trial, NAVA or PSV
measure: cardiac index
timeFrame: last 10 minutes of each ventilatory trial, NAVA or PSV
measure: mean arterial pressure
timeFrame: last 10 minutes of each ventilatory trial, NAVA or PSV
measure: central venous pressure
timeFrame: last 10 minutes of each ventilatory trial, NAVA or PSV
measure: systemic vascular resistance
timeFrame: last 10 minutes of each ventilatory trial, NAVA or PSV
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fabrizio Chiusolo
state: RM
Study officials:
affiliation: Bambino Gesù Hospital and Research Institute
name: Fabrizio Chiusolo, MD
role: PRINCIPAL_INVESTIGATOR
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