NAVA vs PSV Ventilation During Weaning From Mechanical Ventilation in Children After Liver Transplantation

Not Applicable

• Conditions: Weaning From Mechanical Ventilation; Pediatric Liver Transplantation
• Interventions: Procedure: Weaning from mechanical ventilation

• Registration Number: NCT04792788
• Lead Sponsor: Bambino Gesù Hospital and Research Institute

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.

Study Timeline

• Study Start: 2020-09-01
• Status Verified: 2021-02
• Study First Submitted: 2021-02-03
• Study First Submitted QC: 2021-03-08
• Study First Posted: 2021-03-11
• Last Update Submitted: 2021-10-14
• Last Update Posted: 2021-10-22
• Primary Completion: 2021-11-01
• Study Completion: 2022-01-30

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PSV/NAVA/PSV	Weaning from mechanical ventilation	6 patients
NAVA/PSV/NAVA	Weaning from mechanical ventilation	6 patients

Primary Outcome Measures

Name	Time	Method
Left and right ventricle function	last 10 minutes of each ventilatory trial, NAVA or PSV	Evaluation of left and right ventricular function variation during each ventilation mode. It will be measured by trans-thoracic echocardiogram in the last 10 minutes of each ventilatory trial of 40 minutes.
Asynchrony Index	last 10 minutes of each ventilatory trial, NAVA or PSV	Asynchrony Index (ratio between the number of asynchronous breathing events and the total respiratory rate, expressed as percentage) will be measured in the last 10 minutes of each ventilatory trial of 40 minutes.

Secondary Outcome Measures

Name	Time	Method
arterial partial pressure of oxygen (PaO2)	last 10 minutes of each ventilatory trial, NAVA or PSV	millimeters of mercury (mm Hg)
oxygen index	last 10 minutes of each ventilatory trial, NAVA or PSV	{\[mean airway pressure in centimeters of water × fraction of inspired oxygen × 100\] ÷ PaO2 in mm Hg}
systemic vascular resistance	last 10 minutes of each ventilatory trial, NAVA or PSV	\[(mean arterial pressure - central venous pressure) x 79.92 / cardiac index\] in dynes/seconds/cm\^-5
arterial partial pressure of carbon dioxide	last 10 minutes of each ventilatory trial, NAVA or PSV	mm Hg
cardiac index	last 10 minutes of each ventilatory trial, NAVA or PSV	{cardiac output \[stroke volume (milliliter) x heart rate (bpm)\] / body surface area (BSA; weight in kilograms and height in centimeters will be combined to report BSA in m\^2)} in liters/minute/m\^2
respiratory rate	last 10 minutes of each ventilatory trial, NAVA or PSV	breaths per minute
lactate	last 10 minutes of each ventilatory trial, NAVA or PSV	millimole/liter
heart rate	last 10 minutes of each ventilatory trial, NAVA or PSV	beats per minute (bpm)
central venous pressure	last 10 minutes of each ventilatory trial, NAVA or PSV	mm Hg
mean arterial pressure	last 10 minutes of each ventilatory trial, NAVA or PSV	mm Hg

Trial Locations

Locations (1)

Fabrizio Chiusolo; 🇮🇹 Rome, RM, Italy