Electrical Activity of the Diaphragm and Respiratory Mechanics During NAVA
Recruiting now · Not applicable
Conditions studied: Work of Breathing, Lung Transplantation, Neurally Adjusted Ventilatory Assist, Ventilator-Induced Lung Injury, Acute Respiratory Failure (ARF)
In brief
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.
Key facts
- Study ID
- NCT05689476
- Run by
- University of Padova
- People needed
- 40
- Starts
- 2022-12-27
- Expected to finish
- 2025-12-27
- Last updated by the study team
- 2025-07-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Institute of Anaesthesia and Intensive Care, Padua University hospital — Padova, Italy, Italy (enrolling)
Full record on ClinicalTrials.gov
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