Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05689476

Electrical Activity of the Diaphragm and Respiratory Mechanics During NAVA

Led by University of Padova · Updated on 2025-07-08

40

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Protective ventilatory strategy should be applied to reduce ventilator-induced lung injury (VILI) after Lung Transplantation (LTx) or in case of acute respiratory failure requiring invasive mechanical ventilation. Neurally Adjusted Ventilatory Assist (NAVA) is an assisted ventilation mode in which respiratory support is coordinated by the electrical activity of the diaphragm (EAdi). Aim of the study is to assess the physiological relationship between neural respiratory drive, as assessed by EAdi, and tidal volume, driving pressure, and mechanical power, at different levels of ventilatory assist, in the absence of pulmonary vagal afferent feedback or during acute respiratory failure. Additional parameters will be collected: Pmus, Pocc, transpulmonary pressure etc.

CONDITIONS

Official Title

Electrical Activity of the Diaphragm and Respiratory Mechanics During NAVA

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age > 18 years
  • Admitted to ICU for post-operative monitoring after lung transplantation or acute respiratory failure needing invasive mechanical ventilation
  • Presence of spontaneous breathing activity
  • Sedation titrated to a target Richmond Agitation-Sedation Scale (RASS) between 0 and -2
  • Written informed consent obtained
Not Eligible

You will not qualify if you...

  • Contraindication to nasogastric tube insertion (such as gastroesophageal surgery in the previous 3 months, gastroesophageal bleeding in the previous 30 days, history of esophageal varices, facial trauma)
  • Increased risk of bleeding with nasogastric tube insertion due to severe coagulation disorders or severe thrombocytopenia (INR > 2 and platelets count < 70,000/mm3)
  • Severe hemodynamic instability (noradrenaline > 0.3 mcg/kg/min and/or use of vasopressin)
  • Postoperative extracorporeal respiratory support (ECMO)
  • Pre-operative reconditioning of transplanted lungs by ex-vivo lung perfusion (EVLP)
  • Lung retransplantation
  • Failure to obtain a stable electrical activity of the diaphragm (EAdi) signal

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Institute of Anaesthesia and Intensive Care, Padua University hospital

Padova, Italy, Italy, 35120

Actively Recruiting

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Research Team

A

Annalisa Boscolo, MD

CONTACT

N

Nicolò Sella, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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