Institute of Anaesthesia and Intensive Care, Padua University hospital
Padova, Italy, 35120
Location status: Recruiting
NCT Number: NCT05689476
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.
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Request Info18 year and older
All sexes
Interventional
Not applicable
Padova, Italy, 35120
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
NAVA ventilation: Assisted Ventilation Mode, synchronized, through EAdi catheter, with patient's inspiratory effort and proportional to respiratory drive
Time frame: One hour after the recovery of spontaneous breathing
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
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, with inspiratory hold manoeuvres
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
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
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.
Contact information is provided by the study sponsor or research team.
Annalisa Boscolo, MD
CONTACT
Nicolò Sella, MD
CONTACT
University of Padova
Other
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.
Acronym: NAVAMECH
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