Assessing Diaphragm Activity and Breathing Mechanics During NAVA Ventilation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of Neurally Adjusted Ventilatory Assist (NAVA) in patients who have undergone lung transplantation. It focuses on the relationship between the electrical activity of the diaphragm and various respiratory parameters, such as tidal volume and driving pressure, during different levels of ventilatory support. The goal is to understand how NAVA can reduce ventilator-induced lung injury and diaphragm dysfunction in the early postoperative period. Participants will be monitored in the ICU to assess their spontaneous breathing activity and response to NAVA.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age \> 18 y.o.
* Admission to ICU for post-operative monitoring after LTx or acute respiratory failure needing invasive mechanical ventilation
* Presence of spontaneous breathing activity
* Sedation titrated to a target RASS between 0 and -2
* Written informed consent obtained

Exclusion Criteria:

* Contraindication to nasogastric tube insertion (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 and severe thrombocytopenia ( i.e., INR \> 2 and platelets count \< 70.000/mm3)
* Severe hemodynamic instability (noradenaline \> 0.3 μg/kg/min and/or use of vasopressin)
* Postoperative extracorporeal respiratory support (ECMO)
* Pre-operative reconditioning of the transplanted lungs by means of ex-vivo lung perfusion (EVLP)
* Lung retransplantation
* Failure to obtain a stable EAdi signal

Where it's running

• Institute of Anaesthesia and Intensive Care, Padua University hospital
  Padova, Italy, Italy Recruiting

Study contacts

• Study coordinator: Annalisa Boscolo, MD
• Email: annalisa.boscolobozza@aopd.veneto.it
• Phone: +390498213090

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.