Work of Breathing, Lung Transplant; Complications, Neurally Adjusted Ventilatory Assist, Ventilator-Induced Lung Injury
Conditions
Brief summary
Primary Graft Dysfunction (PGD) respresents the leading cause of mortality in early post-operative period of Lung Tranplantation (LTx). Protective ventilatory strategy could potentially reduce the risk of PGD in these patients. Neurally Adjusted Ventilatory Assist (NAVA) is an assisted ventilation mode that could allow to adopt this strategy. Aim of the study is to assess the feasibility of NAVA in the early post-LTx phase and to describe the breathing pattern and the physiological relationship between neural respiratory drive and 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. Primary Graft Dysfunction (PGD) is the main cause of death; in the early period following LTx a protective ventilatory strategy (tidal volume - Vt of 6 mL/Kg + Positive End Expiratory Pressure) could potentially reduce the risk of PGD in these patients. 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). Actually, Guidelines about the adoption of a protective ventilatory strategy in the early post-opeartive period are lacking. NAVA, because of its intrinsic properties (proportionality between respiratory drive and level of assist, prevention of diaphragm atrophy), could allow to reach the afore mentioned ventilatory strategy. So, aim of the study, is the evaluation of patients' neural breathing pattern during NAVA, in early post-operative period of LTx
Interventions
DEVICENAVA ventilation
Assisted Ventilation Mode, synchronized, through EAdi catheter, with patient's inspiratory effort and proportional to respiratory drive
Sponsors
University of Lausanne Hospitals
Policlinico Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the changes in the patient's neural breathing pattern (expressed as respiratory rate) at different levels of ventilatory assist | One hour after the recovery of spontaneous breathing | Respiratory rate (Breaths/min) |
| Evaluation of the variations of Neuro-Mechanical Coupling (expressed as microVolt of EAdi /cmH2O of airway pressure Ratio) in response to different levels of ventilatory assist at different degrees of lung inflation | One hour after the recovery of spontaneous breathing | Neuro-Mechanical Coupling (NMC) (microvolt/cmH2O) |
| Evaluation of the variations of Neuro-ventilatory Efficiency (expressed as microvolt of EAdi / mL of Tidal Volume Ratio) in response to different levels of ventilatory assist at different degree of lung inflation | One hour after the recovery of spontaneous breathing | Neuro-Ventilatory Efficiency (NVE) (microvolt/mL) |
| Evaluation of the changes in the patient's neural breathing pattern (expressed as mL of Tidal Volume) at different levels of ventilatory assist | One hour after the recovery of spontaneous breathing | Tidal Volume (mL) |
| Evaluation of the variations of 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) | One hour after the recovery of spontaneous breathing | Electrical Activity of the Diaphragm (EAdi) (microVolt) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ultrasound assessment of the changes of Diaphragm's Thickening Fraction at different levels of Positive End Expiratory Pressure and at different NAVA gains | One hour after the recovery of spontaneous breathing | Diaphragm's Thickening Fraction (TF) |
| Assesment of the total asynchrony index (double triggering + missed efforts + inspiratory trigger delay +short cycling + prolonged cycling) | One hour after the recovery of spontaneous breathing | Total Asinchrony Index |
| Evaluation of the feasibility of Plateau Pressure during NAVA | One hour after the recovery of spontaneous breathing, with inspiratory hold manoeuvres | Plateau Pressure (Pplat) |
Countries
Italy, Switzerland
Contacts
Primary ContactGiacomo Grasselli, Prof
Outcome results
None listed