Clinical Trials Directory

Trials / Unknown

UnknownNCT03367221

Physiological Response in Lung Transplant Recipients Undergoing Neurally Adjusted Ventilatory Assist

Physiological Response to Different Levels of Support in Lung Transplant Recipients Undergoing Neurally Adjusted Ventilatory Assist (NAVA)

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
20 (estimated)
Sponsor
Policlinico Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
DEVICENAVA ventilationAssisted Ventilation Mode, synchronized, through EAdi catheter, with patient's inspiratory effort and proportional to respiratory drive

Timeline

Start date
2017-11-23
Primary completion
2019-11-01
Completion
2019-11-01
First posted
2017-12-08
Last updated
2017-12-08

Locations

2 sites across 2 countries: Italy, Switzerland

Source: ClinicalTrials.gov record NCT03367221. Inclusion in this directory is not an endorsement.