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

NCT04792788 | Unknown DMC

• 1 other identifier: 1695_OPBG_2018
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Liver Transplantation; Weaning From Mechanical Ventilation

Keywords

mechanical ventilation; liver transplantation; pediatric; neurally adjusted ventilatory assist; weaning; pressure support ventilation

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (10)

• arterial partial pressure of oxygen (PaO2)

  last 10 minutes of each ventilatory trial, NAVA or PSV

• arterial partial pressure of carbon dioxide

  last 10 minutes of each ventilatory trial, NAVA or PSV

• oxygen index

  last 10 minutes of each ventilatory trial, NAVA or PSV

• respiratory rate

  last 10 minutes of each ventilatory trial, NAVA or PSV

• lactate

  last 10 minutes of each ventilatory trial, NAVA or PSV

Study Arms (2)

NAVA/PSV/NAVA

ACTIVE COMPARATOR

6 patients

Procedure: Weaning from mechanical ventilation

PSV/NAVA/PSV

ACTIVE COMPARATOR

6 patients

Procedure: Weaning from mechanical ventilation

Interventions

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.

NAVA/PSV/NAVA; PSV/NAVA/PSV

Eligibility Criteria

• Age: 1 Month - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bambino Gesù Hospital and Research Institute: lead
• Catholic University of the Sacred Heart: collaborator

Study Sites (1)

Fabrizio Chiusolo

Rome, RM, 00165, Italy

RECRUITING

Related Publications (11)

• 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.

  PMID: 3316578 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.

  PMID: 14738299 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.

  PMID: 25368908 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.

  PMID: 17962636 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.

  PMID: 20823760 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.

  PMID: 10634340 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.

  PMID: 2656816 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.

  PMID: 27749511 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.

  PMID: 319686 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.

  PMID: 10562603 BACKGROUND

• 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.

  PMID: 40021754 DERIVED

Study Officials

• Fabrizio Chiusolo, MD

  Bambino Gesù Hospital and Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabrizio Chiusolo, MD

CONTACT

+390668592397; fabrizio.chiusolo@opbg.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: March 11, 2021
• Study Start: September 1, 2020
• Primary Completion: November 1, 2021
• Study Completion: January 30, 2022
• Last Updated: October 22, 2021

Record last verified: 2021-02

Locations

IT (1)