Weaning From Mechanical Ventilation Clinical Trial
— NAVIGATEOfficial 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
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.
Status | Recruiting |
Enrollment | 12 |
Est. completion date | January 30, 2022 |
Est. primary completion date | November 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Month to 10 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Fabrizio Chiusolo | Rome | RM |
Lead Sponsor | Collaborator |
---|---|
Bambino Gesù Hospital and Research Institute | Catholic University of the Sacred Heart |
Italy,
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Chidini G, De Luca D, Conti G, Pelosi P, Nava S, Calderini E. Early Noninvasive Neurally Adjusted Ventilatory Assist Versus Noninvasive Flow-Triggered Pressure Support Ventilation in Pediatric Acute Respiratory Failure: A Physiologic Randomized Controlled Trial. Pediatr Crit Care Med. 2016 Nov;17(11):e487-e495. — View Citation
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Fullington NM, Cauley RP, Potanos KM, O'Melia L, Zurakowski D, Bae Kim H, Seefelder C, Vakili K. Immediate extubation after pediatric liver transplantation: a single-center experience. Liver Transpl. 2015 Jan;21(1):57-62. doi: 10.1002/lt.24036. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Asynchrony Index | 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. | last 10 minutes of each ventilatory trial, NAVA or PSV | |
Primary | Left and right ventricle function | 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. | last 10 minutes of each ventilatory trial, NAVA or PSV | |
Secondary | arterial partial pressure of oxygen (PaO2) | millimeters of mercury (mm Hg) | last 10 minutes of each ventilatory trial, NAVA or PSV | |
Secondary | arterial partial pressure of carbon dioxide | mm Hg | last 10 minutes of each ventilatory trial, NAVA or PSV | |
Secondary | oxygen index | {[mean airway pressure in centimeters of water × fraction of inspired oxygen × 100] ÷ PaO2 in mm Hg} | last 10 minutes of each ventilatory trial, NAVA or PSV | |
Secondary | respiratory rate | breaths per minute | last 10 minutes of each ventilatory trial, NAVA or PSV | |
Secondary | lactate | millimole/liter | last 10 minutes of each ventilatory trial, NAVA or PSV | |
Secondary | heart rate | beats per minute (bpm) | last 10 minutes of each ventilatory trial, NAVA or PSV | |
Secondary | cardiac index | {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 | last 10 minutes of each ventilatory trial, NAVA or PSV | |
Secondary | mean arterial pressure | mm Hg | last 10 minutes of each ventilatory trial, NAVA or PSV | |
Secondary | central venous pressure | mm Hg | last 10 minutes of each ventilatory trial, NAVA or PSV | |
Secondary | systemic vascular resistance | [(mean arterial pressure - central venous pressure) x 79.92 / cardiac index] in dynes/seconds/cm^-5 | last 10 minutes of each ventilatory trial, NAVA or PSV |
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