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Recruiting NCT05689476

Electrical Activity of the Diaphragm and Respiratory Mechanics During NAVA

No phase Interventional Work of Breathing Lung Transplantation Neurally Adjusted Ventilatory Assist Ventilator-Induced Lung Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NAVA GROUP.
Who it may be relevant to
Registry conditions: Work of Breathing, Lung Transplantation, Neurally Adjusted Ventilatory Assist, Ventilator-Induced Lung Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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.

Overview

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.

Interventions

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

Primary outcome measures

  • Electrical Activity of the Diaphragm (EAdi) [Time frame: One hour after the recovery of spontaneous breathing]
  • Tidal Volume (mL) and Respiratory rate (Breaths/min) [Time frame: One hour after the recovery of spontaneous breathing]
Secondary outcome measures (2)
  • Driving pressure (DP) [Time frame: One hour after the recovery of spontaneous breathing, with inspiratory hold manoeuvres]
  • Occlusion Pression (Pocc) [Time frame: One hour after the recovery of spontaneous breathing]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Institute of Anaesthesia and Intensive Care, Padua University hospital — Padova

Identifiers

NCT: NCT05689476 · NAVAMECH

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗