Assessing Diaphragm Activity and Breathing Mechanics During NAVA Ventilation
Evaluation of the Relationship Between Electrical Activity of the Diaphragm and Respiratory Mechanics During Neurally Adjusted Ventilatory Assist in Lung Transplant Patients and in Patients Affected by Acute Respiratory Failure.
This study is testing if a special type of breathing support called NAVA can help lung transplant patients breathe better and protect their lungs while they recover in the ICU.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Padova Academic / other |
| Locations | 1 site (Padova, Italy) |
| Trial ID | NCT05689476 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are admitted to the ICU for monitoring after lung transplantation and exhibit spontaneous breathing activity.
Not a fit: Patients with severe hemodynamic instability or contraindications to nasogastric tube insertion may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve respiratory outcomes and reduce complications for lung transplant patients.
How similar studies have performed: While the use of NAVA is established, this specific evaluation of its effects post-lung transplantation is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Padova, Italy
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.