Clinical Trials

Novalung is supporting a number of clinical trials. A few examples of prospective, randomized clinical trials are presented below.

XTRAVENT TRIAL
Extrapulmonary interventional ventilatory support for lung protection in severe ARDS – a prospective randomized multi centre study

 

Principal Investigator:	Prof. Dr. Thomas Bein, Klinik für Anästhesiologie, Regensburg University Hospital, Germany
Design:	Prospective, randomized multi-center trial with a recruitment target of 120 Patients.
Descirption:	The effects of the interventional lung assist (iLA Membrane Ventilator®) on the implementation of lung-protective ventilation strategies in patients with ARDS are compared to standarized ventilation therapy.
Endpoint:	Primary endpoint is the number of ventilator-free days in the first 28 days after randomization.

www.clinicaltrials.gov

 

Prospective, single-center trial of the influence of pumpless extracorporeal lung assist (iLA Membrane Ventilator®) in patients with exacerbated Chronic Obstructive Pulmonary Disease

 

Principal Investigator:	Dr. Stefan Kluge, Klinik für Intensivmedizin, Hamburg-Eppendorf University Hospital, Germany
Design:	Prospective, single-center trial with a recruitment target of 10 patients.
Description:	This trial is designed to test the hypothesis that it is beneficial to expand acute treatment of decompensated COPD with breathing pump failure to include extracorporeal CO2 removal. The intention is to show that this innovative technology can be used to prevent endotracheal intubation and the associated use of invasive and potentially damaging mechanical ventilation.
Endpoint:	Primary endpoint is a reduction in the incidence of endotracheal intubation.

www.uke.de

 

Clinical Investigation of Safety and Efficacy of the Novalung Interventional Lung Assist System (iLA Membranventilator®) as a Bridge to Lung Transplant

 

Principal Investigator:	Shaf Keshavjee MD, MSc FRCSC FACS Director, Toronto Lung Transplant Program, Toronto General Hospital/Canada
Design:	Single-center trial at Toronto General Hospital.
Description:	Goal of the trial is the evaluation of the safety, efficacy and performance of the Novalung Interventional Lung Assist (iLA Membrane Ventilator®) as bridge-to-lung-transplant in patients with refractory ventilatory failure or patients who require respiratory support directly after lung transplantation.

 

OSCAR TRIAL
High Frequency OSCillation in ARDS

 

Principal Investigator:	Duncan Young, Director of Research for the Intensive Care Society and Clinical Director of the Intensive Care Unit, John Radcliffe Hospital, Oxford, United Kingdom
Design:	Multicenter (> 10 sites in the UK), randomized clinical trial with a recruitment target of 802 patients.
Description:	Conventional pressure-controlled mechanical ventilation is compared to High-Frequency Oscillating Ventilation (HFOV) in adult patients with ARDS. Patients in the HFOV group are treated exclusively with the Vision α®.
Endpoint:	Primary endpoint is the difference in mortality between the two arms 30 days after randomization.

This trial is sponsored by the University of Oxford.

www.duncanyoung.net