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Pediatric Liver TransplantationNAVIGATENCT04792788

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

A study testing Weaning from mechanical ventilation in people with Pediatric Liver Transplantation and Weaning From Mechanical Ventilation, run by Bambino Gesù Hospital and Research Institute at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 month to 10 years
What is being tested?
Weaning from mechanical ventilation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteItaly
Study dates
1 Sep 2020to 30 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 month to 10 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Fabrizio Chiusolo, MD contact

+390668592397

fabrizio.chiusolo@opbg.net

Italy1 site, 1 recruiting

  • Fabrizio Chiusolo

    Rome, RM, 00165

    Fabrizio Chiusolo, MD, +390668592397, fabrizio.chiusolo@opbg.net

    Recruiting

Other trials in Italy

About this study

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

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.

Read the 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.

Being tested
Weaning from mechanical ventilation
Keywords
mechanical ventilation, liver transplantation, pediatric, neurally adjusted ventilatory assist, weaning, pressure support ventilation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Weaning from mechanical ventilationProcedure or surgery

    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.

Study groups in NCT04792788
Study groupRoleWhat they receive
NAVA/PSV/NAVAActive comparator6 patients
Receives: Procedure: Weaning from mechanical ventilation
PSV/NAVA/PSVActive comparator6 patients
Receives: Procedure: Weaning from mechanical ventilation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: last 10 minutes of each ventilatory trial, NAVA or PSV

  2. 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.

    Measured: last 10 minutes of each ventilatory trial, NAVA or PSV

Secondary outcomes (10)

  1. arterial partial pressure of oxygen (PaO2)

    millimeters of mercury (mm Hg)

    Measured: last 10 minutes of each ventilatory trial, NAVA or PSV

  2. arterial partial pressure of carbon dioxide

    mm Hg

    Measured: last 10 minutes of each ventilatory trial, NAVA or PSV

  3. oxygen index

    {[mean airway pressure in centimeters of water × fraction of inspired oxygen × 100] ÷ PaO2 in mm Hg}

    Measured: last 10 minutes of each ventilatory trial, NAVA or PSV

  4. respiratory rate

    breaths per minute

    Measured: last 10 minutes of each ventilatory trial, NAVA or PSV

  5. lactate

    millimole/liter

    Measured: last 10 minutes of each ventilatory trial, NAVA or PSV

  6. heart rate

    beats per minute (bpm)

    Measured: last 10 minutes of each ventilatory trial, NAVA or PSV

  7. 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

    Measured: last 10 minutes of each ventilatory trial, NAVA or PSV

  8. mean arterial pressure

    mm Hg

    Measured: last 10 minutes of each ventilatory trial, NAVA or PSV

  9. central venous pressure

    mm Hg

    Measured: last 10 minutes of each ventilatory trial, NAVA or PSV

  10. systemic vascular resistance

    [(mean arterial pressure - central venous pressure) x 79.92 / cardiac index] in dynes/seconds/cm^-5

    Measured: last 10 minutes of each ventilatory trial, NAVA or PSV

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2021
  2. Study start1 Sep 2020
  3. Primary completion1 Nov 2021 (estimated)
  4. Study completion30 Jan 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04792788
Sponsor's protocol ID
1695_OPBG_2018
Acronym
NAVIGATE
Status last verified
Feb 2021
First submitted
3 Feb 2021
Last updated
22 Oct 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 3316578

  • 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.

    PubMed 14738299

  • 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.

    PubMed 25368908

  • 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.

    PubMed 17962636

  • 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.

    PubMed 20823760

  • 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.

    PubMed 10634340

  • 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.

    PubMed 2656816

  • 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.

    PubMed 27749511

  • 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.

    PubMed 319686

  • 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.

    PubMed 10562603

  • 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.

    PubMed 40021754

Questions about this trial

What is this clinical trial studying?

A study testing Weaning from mechanical ventilation in people with Pediatric Liver Transplantation and Weaning From Mechanical Ventilation, run by Bambino Gesù Hospital and Research Institute at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fabrizio Chiusolo, MD (+390668592397, fabrizio.chiusolo@opbg.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Asynchrony Index (time frame: last 10 minutes of each ventilatory trial, NAVA or PSV). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04792788, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.

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