RecruitingNot Applicable

Electrical Activity of the Diaphragm and Respiratory Mechanics During NAVA

Italy40 participantsStarted 2022-12-27

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Electrical Activity of the Diaphragm (EAdi)

Timeframe: One hour after the recovery of spontaneous breathing

Tidal Volume (mL) and Respiratory rate (Breaths/min)

Timeframe: One hour after the recovery of spontaneous breathing

Trial details

NCT IDNCT05689476

SponsorUniversity of Padova

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-27

Contact for this trial

Annalisa Boscolo, MD

+390498213090 annalisa.boscolobozza@aopd.veneto.it