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

NCT ID: NCT04792788

Last Updated: 2021-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2022-01-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pediatric Liver Transplantation Weaning From Mechanical Ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NAVA/PSV/NAVA

6 patients

Group Type ACTIVE_COMPARATOR

Weaning from mechanical ventilation

Intervention Type 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.

PSV/NAVA/PSV

6 patients

Group Type ACTIVE_COMPARATOR

Weaning from mechanical ventilation

Intervention Type 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.

Interventions

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Weaning from mechanical ventilation

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catholic University of the Sacred Heart

OTHER

Sponsor Role collaborator

Bambino Gesù Hospital and Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fabrizio Chiusolo, MD

Role: PRINCIPAL_INVESTIGATOR

Bambino Gesù Hospital and Research Institute

Locations

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Fabrizio Chiusolo

Rome, RM, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Fabrizio Chiusolo, MD

Role: CONTACT

[email protected]
+390668592397

Facility Contacts

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Fabrizio Chiusolo, MD

Role: primary

[email protected]
+390668592397

References

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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.

Reference Type BACKGROUND
PMID: 10634340 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3316578 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14738299 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25368908 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17962636 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20823760 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2656816 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27749511 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 319686 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10562603 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40021754 (View on PubMed)

Other Identifiers

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1695_OPBG_2018

Identifier Type: -

Identifier Source: org_study_id