Electrical Activity of the Diaphragm and Respiratory Mechanics During NAVA

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Padova

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • NAVA GROUP

    Device

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

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: NAVA groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Electrical Activity of the Diaphragm (EAdi)

Evaluation of the variations of tidal volume Electrical Activity of the Diaphragm in response to different levels of ventilatory assist at different degrees of lung inflation (different Positive End Expiratory Pressure values). Electrical Activity of the Diaphragm (EAdi) (microVolt)

Time frame
One hour after the recovery of spontaneous breathing
2

Tidal Volume (mL) and Respiratory rate (Breaths/min)

Evaluation of the changes in the patient's neural breathing pattern (expressed as mL of Tidal Volume) at different levels of ventilatory assist. Also patient's respiratory rate (Breaths/min) will be evaluated

Time frame
One hour after the recovery of spontaneous breathing

Secondary outcomes

1

Driving pressure (DP)

Evaluation of the variations of DP in response to different levels of ventilatory assist at different degrees of lung inflation. The driving pressure formula is DP = P\_plateau - PEEP. It represents the pressure difference between the plateau pressure (P\_plateau) and the positive end-expiratory pressure (PEEP) during mechanical ventilation. Unit: mmHg or cmH2O.

Time frame
One hour after the recovery of spontaneous breathing, with inspiratory hold manoeuvres
2

Occlusion Pression (Pocc)

Evaluation of the changes in the patient's respiratory effort (evaluated using Pocc) at different levels of ventilatory assist. The full breath occlusion pressure (Pocc) is the drop in airway-Pressre during a full occluded inspiratory effort. Unit: mmHg or cmH2O.

Time frame
One hour after the recovery of spontaneous breathing

Other outcomes

1

PaO2/FiO2 ratio

Evaluation of the changes in gas exchange, in particular in PaO2/FiO2 ratio, at different levels of ventilatory assist. The emogas analysis was collected from a peripheral artery.

Time frame
One hour after the recovery of spontaneous breathing

Sponsors and contacts

Click on the lead sponsor to view all of their trials.