Clinical trial NCT03367221: Physiological Response in Lung Transplant Recipients Undergoing Neurally Adjusted Ventilatory Assist
Official title: Physiological Response to Different Levels of Support in Lung Transplant Recipients Undergoing Neurally Adjusted Ventilatory Assist (NAVA)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Work of Breathing
Lung Transplant; Complications
Neurally Adjusted Ventilatory Assist
Ventilator-Induced Lung Injury
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
Collaborators: name: University of Lausanne Hospitals
First posted: 2017-12-08
Enrollment: 20
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: 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

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: 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)
timeFrame: One hour after the recovery of spontaneous breathing
measure: 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
timeFrame: One hour after the recovery of spontaneous breathing
measure: 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
timeFrame: One hour after the recovery of spontaneous breathing
measure: Evaluation of the changes in the patient's neural breathing pattern (expressed as mL of Tidal Volume) at different levels of ventilatory assist
timeFrame: One hour after the recovery of spontaneous breathing
measure: Evaluation of the changes in the patient's neural breathing pattern (expressed as respiratory rate) at different levels of ventilatory assist
timeFrame: One hour after the recovery of spontaneous breathing
Secondary outcomes:
measure: Evaluation of the feasibility of Plateau Pressure during NAVA
timeFrame: One hour after the recovery of spontaneous breathing, with inspiratory hold manoeuvres
measure: Ultrasound assessment of the changes of Diaphragm's Thickening Fraction at different levels of Positive End Expiratory Pressure and at different NAVA gains
timeFrame: One hour after the recovery of spontaneous breathing
measure: Assesment of the total asynchrony index (double triggering + missed efforts + inspiratory trigger delay +short cycling + prolonged cycling)
timeFrame: One hour after the recovery of spontaneous breathing
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Ospedale Maggiore Policlinico
city: Lausanne
country: Switzerland
facility: University Hospital of Lausanne
Study officials:
affiliation: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: Chiara Abbruzzese, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: Luigi Castagna, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: Nicola Bottino, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Milan
name: Alberto Zanella, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione IRCCS Ca' Granda
name: Nadia Corcione, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Milan
name: Antonio Pesenti, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.