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| Name | Class |
|---|---|
| University of Lausanne Hospitals | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NAVA group | Experimental | NAVA ventilation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NAVA ventilation | Device | Assisted Ventilation Mode, synchronized, through EAdi catheter, with patient's inspiratory effort and proportional to respiratory drive |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Electrical Activity of the Diaphragm (EAdi) (microVolt) | One hour after the recovery of spontaneous breathing |
| 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 | Neuro-Mechanical Coupling (NMC) (microvolt/cmH2O) | One hour after the recovery of spontaneous breathing |
| 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 | Neuro-Ventilatory Efficiency (NVE) (microvolt/mL) | 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 | Tidal Volume (mL) | One hour after the recovery of spontaneous breathing |
| Evaluation of the changes in the patient's neural breathing pattern (expressed as respiratory rate) at different levels of ventilatory assist | Respiratory rate (Breaths/min) | One hour after the recovery of spontaneous breathing |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the feasibility of Plateau Pressure during NAVA | Plateau Pressure (Pplat) | One hour after the recovery of spontaneous breathing, with inspiratory hold manoeuvres |
| Ultrasound assessment of the changes of Diaphragm's Thickening Fraction at different levels of Positive End Expiratory Pressure and at different NAVA gains |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giacomo Grasselli, Prof | Contact | 0255033258 | giacomo.grasselli@unimi.it |
| Name | Affiliation | Role |
|---|---|---|
| Chiara Abbruzzese, MD | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | Principal Investigator |
| Luigi Castagna, MD | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Maggiore Policlinico | Recruiting | Milan | 20122 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33892948 | Derived | Grasselli G, Castagna L, Abbruzzese C, Corcione N, Bottino N, Guzzardella A, Colombo SM, Carlesso E, Mauri T, Rossetti V, Palleschi A, Scaravilli V, Zanella A, Pesenti A. Pulmonary volume-feedback and ventilatory pattern after bilateral lung transplantation using neurally adjusted ventilatory assist ventilation. Br J Anaesth. 2021 Jul;127(1):143-152. doi: 10.1016/j.bja.2021.03.010. Epub 2021 Apr 21. |
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Diaphragm's Thickening Fraction (TF) |
| One hour after the recovery of spontaneous breathing |
| Assesment of the total asynchrony index (double triggering + missed efforts + inspiratory trigger delay +short cycling + prolonged cycling) | Total Asinchrony Index | One hour after the recovery of spontaneous breathing |
| Nicola Bottino, MD | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | Principal Investigator |
| Alberto Zanella, MD | University of Milan | Principal Investigator |
| Nadia Corcione, MD | Fondazione IRCCS Ca' Granda | Principal Investigator |
| Antonio Pesenti, Prof | University of Milan | Principal Investigator |
| University Hospital of Lausanne | Recruiting | Lausanne | 10111 | Switzerland |
|
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| ID | Term |
|---|---|
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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