NCT05689476

Electrical Activity of the Diaphragm and Respiratory Mechanics During NAVA

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Padova · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Lung transplantation (LTx) is an important treatment option for select patients with end-stage pulmonary disease, while acute respiratory failure is a common disease among ICU patients. In the early period, following LTx or at the beginning of acute respiratory failure, a protective ventilatory strategy should be applied to reduce ventilator-induced lung injury (VILI). Neurally Adjusted Ventilatory Assist (NAVA) is an assisted ventilation mode in which neural inspiratory activity is monitored through the continuous recording of electrical activity of the diaphragm (EAdi) and then used to coordinate the respiratory support delivered by the ventilator. NAVA, because of its intrinsic properties (proportionality between respiratory drive and level of assist, prevention of diaphragm atrophy), could allow the aforementioned ventilatory strategy, however it may require the integrity of the pulmonary vagal afferent feedback in order to avoid volutrauma. So, the aim of the study is the evaluation of the physiological relationship between EAdi and tidal volume, driving pressure and mechanical power, at different levels of ventilatory assist, in the absence of pulmonary vagal afferent feedback during early post-operative period after LTx and among critically ill patients affected by acute respiratory failure. Finally, additional parameters will be collected: Pmus, Pocc, transpulmonary pressure etc.

Conditions

• Work of Breathing
• Lung Transplantation
• Neurally Adjusted Ventilatory Assist
• Ventilator-Induced Lung Injury
• Acute Respiratory Failure (ARF)

Interventions

Type	Name	Description
DEVICE	NAVA GROUP	NAVA ventilation: Assisted Ventilation Mode, synchronized, through EAdi catheter, with patient's inspiratory effort and proportional to respiratory drive

Timeline

• Start date: 2022-12-27
• Primary completion: 2025-12-27
• Completion: 2025-12-27
• First posted: 2023-01-19
• Last updated: 2025-07-08

Locations

1 site across 1 country: Italy