NCT05689476 Electrical Activity of the Diaphragm and Respiratory Mechanics During NAVA
| NCT ID | NCT05689476 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Padova |
| Condition | Work of Breathing |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-12-27 |
| Primary Completion | 2025-12-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2022-12-27 with a primary completion date of 2025-12-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05689476 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Work of Breathing. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05689476 currently recruiting?
Yes, NCT05689476 is actively recruiting participants. Contact the research team at annalisa.boscolobozza@aopd.veneto.it for enrollment information.
Where is the NCT05689476 trial being conducted?
This trial is being conducted at Padova, Italy.
Who is sponsoring the NCT05689476 clinical trial?
NCT05689476 is sponsored by University of Padova. The trial plans to enroll 40 participants.