Electrical Activity of the Diaphragm and Respiratory Mechanics During NAVA

NCT ID: NCT05689476

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-27
• Study Completion Date: 2025-12-27

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.

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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NAVA group

Nava ventilation

Group Type: EXPERIMENTAL

NAVA GROUP

Intervention Type: DEVICE

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

Interventions

NAVA GROUP

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Padova

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute of Anaesthesia and Intensive Care, Padua University hospital

Padua, Italy, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Annalisa Boscolo, MD

Role: CONTACT

annalisa.boscolobozza@aopd.veneto.it

+390498213090

Nicolò Sella, MD

Role: CONTACT

nico.sella@hotmail.it

+390498213090

Facility Contacts

Annalisa Boscolo, MD, PhD

Role: primary

annalisa.boscolobozza@aopd.veneto.it

+393498324972

Other Identifiers

NAVAMECH

Identifier Type: -

Identifier Source: org_study_id