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| Name | Class |
|---|---|
| Catholic University of the Sacred Heart | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NAVA/PSV/NAVA | Active Comparator | 6 patients |
|
| PSV/NAVA/PSV | Active Comparator | 6 patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weaning from mechanical ventilation | Procedure | Cross over study: 3 periods of 40 minutes in ventilation mode (NAVA or PSV); to register ventilator traces and cardiopulmonary parameters during the last 10 minutes of each period. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| arterial partial pressure of oxygen (PaO2) | millimeters of mercury (mm Hg) | last 10 minutes of each ventilatory trial, NAVA or PSV |
| arterial partial pressure of carbon dioxide | mm Hg |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fabrizio Chiusolo, MD | Contact | +390668592397 | fabrizio.chiusolo@opbg.net |
| Name | Affiliation | Role |
|---|---|---|
| Fabrizio Chiusolo, MD | Bambino Gesù Hospital and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fabrizio Chiusolo | Recruiting | Rome | RM | 00165 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3316578 | Background | Esquivel CO, Iwatsuki S, Gordon RD, Marsh WW Jr, Koneru B, Makowka L, Tzakis AG, Todo S, Starzl TE. Indications for pediatric liver transplantation. J Pediatr. 1987 Dec;111(6 Pt 2):1039-45. doi: 10.1016/s0022-3476(87)80053-7. | |
| 14738299 | Background | Ulukaya S, Arikan C, Aydogdu S, Ayanoglu HO, Tokat Y. Immediate tracheal extubation of pediatric liver transplant recipients in the operating room. Pediatr Transplant. 2003 Oct;7(5):381-4. doi: 10.1034/j.1399-3046.2003.00072.x. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 7, 2026 | |
| Reset | Jan 22, 2026 |
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| last 10 minutes of each ventilatory trial, NAVA or PSV |
| 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 |
| respiratory rate | breaths per minute | last 10 minutes of each ventilatory trial, NAVA or PSV |
| lactate | millimole/liter | last 10 minutes of each ventilatory trial, NAVA or PSV |
| heart rate | beats per minute (bpm) | last 10 minutes of each ventilatory trial, NAVA or PSV |
| 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 |
| mean arterial pressure | mm Hg | last 10 minutes of each ventilatory trial, NAVA or PSV |
| central venous pressure | mm Hg | last 10 minutes of each ventilatory trial, NAVA or PSV |
| 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 |
| 25368908 | Background | 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. |
| 17962636 | Background | Esteban A, Ferguson ND, Meade MO, Frutos-Vivar F, Apezteguia C, Brochard L, Raymondos K, Nin N, Hurtado J, Tomicic V, Gonzalez M, Elizalde J, Nightingale P, Abroug F, Pelosi P, Arabi Y, Moreno R, Jibaja M, D'Empaire G, Sandi F, Matamis D, Montanez AM, Anzueto A; VENTILA Group. Evolution of mechanical ventilation in response to clinical research. Am J Respir Crit Care Med. 2008 Jan 15;177(2):170-7. doi: 10.1164/rccm.200706-893OC. Epub 2007 Oct 25. |
| 20823760 | Background | Coisel Y, Chanques G, Jung B, Constantin JM, Capdevila X, Matecki S, Grasso S, Jaber S. Neurally adjusted ventilatory assist in critically ill postoperative patients: a crossover randomized study. Anesthesiology. 2010 Oct;113(4):925-35. doi: 10.1097/ALN.0b013e3181ee2ef1. |
| 10634340 | Background | Antonelli M, Conti G, Bufi M, Costa MG, Lappa A, Rocco M, Gasparetto A, Meduri GU. Noninvasive ventilation for treatment of acute respiratory failure in patients undergoing solid organ transplantation: a randomized trial. JAMA. 2000 Jan 12;283(2):235-41. doi: 10.1001/jama.283.2.235. |
| 2656816 | Background | Moulin D, Clement de Clety S, Reynaert M, Carlier MA, Veyckmans F, Claus D, Buts JP, de Hemptinne B, Otte JB. Intensive care for children after orthotopic liver transplantation. Intensive Care Med. 1989;15 Suppl 1:S71-2. doi: 10.1007/BF00260893. |
| 27749511 | Background | 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. doi: 10.1097/PCC.0000000000000947. |
| 319686 | Background | Scharf SM, Caldini P, Ingram RH Jr. Cardiovascular effects of increasing airway pressure in the dog. Am J Physiol. 1977 Jan;232(1):H35-43. doi: 10.1152/ajpheart.1977.232.1.H35. |
| 10562603 | Background | Vieillard-Baron A, Loubieres Y, Schmitt JM, Page B, Dubourg O, Jardin F. Cyclic changes in right ventricular output impedance during mechanical ventilation. J Appl Physiol (1985). 1999 Nov;87(5):1644-50. doi: 10.1152/jappl.1999.87.5.1644. |
| 40021754 | Derived | Chiusolo F, Spinazzola G, Costa R, Franceschini A, Tortora F, Polisca F, Rossetti E, Rava L, Chinali M, Fanelli V, Conti G. Effect of neurally adjusted ventilator assist versus pressure support ventilation on asynchronies and cardiac function in pediatric liver transplantation. Sci Rep. 2025 Feb 28;15(1):7158. doi: 10.1038/s41598-025-91590-z. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 7, 2026 | Jan 22, 2026 |