Electrical Activity of the Diaphragm and Respiratory Mechanics During NAVA

Launched by UNIVERSITY OF PADOVA · Jan 9, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how a special type of breathing support called Neurally Adjusted Ventilatory Assist (NAVA) affects the diaphragm's electrical activity and overall breathing mechanics in patients who have just undergone a lung transplant. The goal is to find out how well this method helps patients breathe without causing additional lung injuries or problems with the diaphragm. By closely monitoring patients in the intensive care unit (ICU), researchers hope to understand the relationship between the diaphragm's signals and how much air is being delivered to the lungs.

To participate in this trial, patients must be over 18 years old and admitted to the ICU for monitoring after their lung transplant surgery. They should also be able to breathe on their own, even if they are receiving some assistance. It’s important that patients do not have certain medical conditions that could complicate the study, such as recent surgeries on the esophagus or severe bleeding disorders. Participants can expect to be closely monitored while researchers assess how the NAVA system is working for their breathing needs. This study is currently looking for volunteers, so if you think you may qualify, please talk to your healthcare team for more information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age \> 18 y.o.
• • Admission to ICU for post-operative monitoring after LTx
• • 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