Actively Recruiting
Evaluation of Electrical Activity of the Diaphragm and Respiratory Mechanics During Neurally Adjusted Ventilatory Assist in Lung Transplant and Acute Respiratory Failure Patients
Led by University of Padova · Updated on 2025-07-08
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying protective ventilatory strategies to reduce lung injury caused by mechanical ventilation in patients after lung transplantation or those experiencing acute respiratory failure requiring invasive ventilation. This research focuses on a ventilation mode called Neurally Adjusted Ventilatory Assist (NAVA), which uses the electrical activity of the diaphragm (EAdi) to coordinate breathing support. The study aims to explore how neural respiratory drive relates to tidal volume, driving pressure, and mechanical power at different assist levels, especially when pulmonary vagal afferent feedback is absent. Participants will receive NAVA ventilation, an assisted mode synchronized with their inspiratory effort through an EAdi catheter, which adjusts support proportional to their respiratory drive. The study evaluates these relationships during the early postoperative period after lung transplantation and in critically ill patients with acute respiratory failure. Additional respiratory parameters such as muscle pressure, occlusion pressure, and transpulmonary pressure will also be collected. During the trial, participants will be monitored one hour after regaining spontaneous breathing. Measurements include electrical activity of the diaphragm, tidal volume, respiratory rate, driving pressure, and occlusion pressure. Sedation levels and spontaneous breathing activity will be assessed, and researchers will track ventilation mechanics to better understand how NAVA affects breathing. The study continues until December 2025, focusing on these physiological outcomes without masking or placebo controls.
CONDITIONS
Brief Title
Electrical Activity of the Diaphragm and Respiratory Mechanics During NAVA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Admission to ICU for post-operative monitoring after lung transplantation or acute respiratory failure requiring invasive mechanical ventilation
- Presence of spontaneous breathing activity
- Sedation level titrated to a target Richmond Agitation Sedation Scale (RASS) score between 0 and -2
- Written informed consent obtained
You will not qualify if you...
- Contraindication to nasogastric tube insertion, including recent gastroesophageal surgery, recent gastroesophageal bleeding, history of esophageal varices, or facial trauma
- Severe coagulation disorders or thrombocytopenia increasing bleeding risk with nasogastric tube insertion (INR > 2 and platelets count < 70,000/mm3)
- Severe hemodynamic instability requiring high-dose noradrenaline or vasopressin
- Use of postoperative extracorporeal respiratory support (ECMO)
- Pre-operative lung reconditioning via ex-vivo lung perfusion (EVLP)
- Lung retransplantation
- Failure to obtain a stable electrical activity of the diaphragm (EAdi) signal
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of invasive mechanical ventilation during ICU stay
Participants receive assisted ventilation using the Neurally Adjusted Ventilatory Assist (NAVA) mode, which synchronizes ventilatory support with the participant's inspiratory effort via an electrical activity of the diaphragm catheter.
Continuous monitoring during ventilation period
Duration - Approximately 1 hour after recovery of spontaneous breathing
Participants are observed for respiratory parameters one hour after recovery of spontaneous breathing to assess electrical activity of the diaphragm and respiratory mechanics.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Institute of Anaesthesia and Intensive Care, Padua University hospital
Padova, Italy, Italy, 35120
Actively Recruiting
Research Team
A
Annalisa Boscolo, MD
N
Nicolò Sella, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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