Clinical trial NCT05689476: Electrical Activity of the Diaphragm and Respiratory Mechanics During NAVA
Official title: Evaluation of the Relationship Between Electrical Activity of the Diaphragm and Respiratory Mechanics During Neurally Adjusted Ventilatory Assist in Lung Transplant Patients.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Work of Breathing
Lung Transplantation
Neurally Adjusted Ventilatory Assist
Ventilator-Induced Lung Injury
Keywords: Lung Injury
Ventilator-Induced Lung Injury
Neurally Adjusted Ventilatory Assist
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Protective ventilatory strategy should be applied to reduce both ventilator-induced lung injury (VILI) and ventilator-induced diaphragm dysfunction (VIDD) after Lung Transplantation (LTx). 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.

Detailed description: Lung transplantation (LTx) is an important treatment option for select patients with end-stage pulmonary disease. In the early period following LTx a protective ventilatory strategy should be applied to reduce both ventilator-induced lung injury (VILI) and ventilator-induced diaphragm dysfunction (VIDD) after Lung Tranplantation (LTx). 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, in early post-operative period after LTx.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 y.o.
* Admission to ICU for post-operative monitoring after LTx
* 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

Primary outcomes:
measure: Electrical Activity of the Diaphragm (EAdi)
timeFrame: One hour after the recovery of spontaneous breathing
measure: Neuro-Mechanical Coupling (NMC)
timeFrame: One hour after the recovery of spontaneous breathing
measure: Neuro-Ventilatory Efficiency (NVE)
timeFrame: One hour after the recovery of spontaneous breathing
measure: Respiratory rate (Breaths/min)
timeFrame: One hour after the recovery of spontaneous breathing
Secondary outcomes:
measure: Plateau Pressure (Pplat)
timeFrame: One hour after the recovery of spontaneous breathing, with inspiratory hold manoeuvres
measure: Diaphragm's Thickening Fraction (TF)
timeFrame: One hour after the recovery of spontaneous breathing
measure: Total Asinchrony Index
timeFrame: One hour after the recovery of spontaneous breathing
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Institute of Anaesthesia and Intensive Care, Padua University hospital
Study officials:
References: