Does Automated Closed-Loop Ventilation Reduce the DRiving Pressure Levels in Patients With ARDS

Summary

The objective of this crossover study and randomized controlled trial (RCT) is to compare ΔP levels during INTELLiVENT®-ASV with conventional lung protective ventilation in the acute and sub-acute phase of moderate or severe ARDS.

A total of 48 adult patients admitted to intensive care units with moderate or severe ARDS will be included. In the acute phase patients will receive 4 hours of INTELLiVENT-ASV ventilation and 4 hours of conventional lung protective ventilation in random order. After these two blocks the patients are allocated into either the INTELLiVENT-ASV arm or the conventional lung protective ventilation arm.

in the sub-acute phase patients will be assessed every day until day 7 or extubation, whichever comes first.

Primary endpoint is the transpulmonary transpulmonary (ΔP). Secondary endpoints of both studies include other ventilator settings and ventilation parameters, as well as time spent at a ΔP level of 15 cm H2O or higher.

Conditions

• ARDS

Interventions

DEVICE

INTELLiVENT-ASV

INTELLiVENT-ASV, with software 2.60

OTHER

Conventional lung protective ventilation

Lung protective ventilation according to the ARDSnet guidelines

Sponsors & Collaborators

• Hamilton Medical AG

  collaborator INDUSTRY

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  lead OTHER

Principal Investigators

• David MP van Meenen, MD, MSc · Department of Intensive Care, Academic Medical Center, University of Amsterdam

• Marcus J Schultz, MD, PhD · Department of Intensive Care, Academic Medical Center, University of Amsterdam

• Marcello Gama de Abreu, MD, PhD · Department of Anesthesiology and Intensive Care Medicine, University Hospital Carl Gustav Carus, Technical University Dresden, Germany

• Ary Serpa Neto, MD, MSc · Department of Intensive Care, Academic Medical Center, University of Amsterdam, The Netherlands

• Paolo Pelosi, MD, PhD · Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Italy

• Jitske R Rogmans · Department of Intensive Care, Academic Medical Center, University of Amsterdam

• Lennard HL Pennekamp · Department of Intensive Care, Academic Medical Center, University of Amsterdam

• Frank C Dullemeijer · Department of Intensive Care, Academic Medical Center, University of Amsterdam

• Marco Maggiorini, MD, PhD · Department of Intensive Care, Universitatsspital, Zurich

• Dominik Novotni, MD, PhD · Hamilton Medical AG

• Alexandra Gerlach · Hamilton Medical AG

• Job BM van Woensel, MD, PhD · Department of Intensive Care, Academic Medical Center, University of Amsterdam

• Jean-Michel Arnal, MD, PhD · Department of Intensive Care, Intercommunal hospital, Toulon

• Patricia Rocco, MD, PhD · Laboratory of pulmonary investigation, Federal University, Rio de Janeiro

• Dave A Dongelmans, MD, PhD · Department of Intensive Care, Academic Medical Center, University of Amsterdam

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-11-03

Primary Completion

2019-03-01

Completion

2019-03-01

Countries

• Netherlands

Study Locations