Viewing Study NCT03367221



Ignite Creation Date: 2024-05-06 @ 10:51 AM
Last Modification Date: 2024-10-26 @ 12:36 PM
Study NCT ID: NCT03367221
Status: UNKNOWN
Last Update Posted: 2017-12-08
First Post: 2017-11-24

Brief Title: Physiological Response in Lung Transplant Recipients Undergoing Neurally Adjusted Ventilatory Assist
Sponsor: Policlinico Hospital
Organization: Policlinico Hospital

Study Overview

Official Title: Physiological Response to Different Levels of Support in Lung Transplant Recipients Undergoing Neurally Adjusted Ventilatory Assist NAVA
Status: UNKNOWN
Status Verified Date: 2017-12
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: TRANS-NAVA
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 mLKg 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None