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Search / Trial NCT03211494

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

Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Jul 6, 2017

Trial Information

Current as of May 20, 2025

Terminated

Keywords

Mechanical Ventilation Driving Pressure Closed Loop Ventilation Esophageal Catheter

ClinConnect Summary

- Objective:

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

- Study design:

Single center crossover study (in the acute phase) and RCT (in the sub-acute phase).

- Study population:

The study population consists of 48 consecutive intubated and ventilation patients with moderate or severe ARDS according to the Berlin definition with an anticipated duration of mechanical venti...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Admission to the ICU of the AMC
  • Intubated and mechanically ventilated
  • Within 24 hours of initial diagnosis of ARDS
  • Moderate or severe ARDS (according to the Berlin definition for ARDS)
  • Exclusion Criteria:
  • Age \< 18 years
  • Patients previously included in this study
  • Patients participating in other interventional trials that could influence ventilator settings and ventilation parameters
  • Patients with suspected or confirmed pregnancy
  • Patients with increased (of \> 15 mmHg) or uncontrollable intracranial pressure
  • Patients in whom esophageal pressure measurement is contra-indicated (severe bleeding diathesis, suspicion of or known pharyngeal or esophageal obstruction, esophageal ulcers, varices or strictures)
  • Moribund patients

About Academisch Medisch Centrum Universiteit Van Amsterdam (Amc Uva)

The Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is a leading academic medical center in the Netherlands, dedicated to advancing healthcare through innovative research, education, and patient care. Affiliated with the University of Amsterdam, AMC-UvA integrates clinical practice with cutting-edge biomedical research, fostering a multidisciplinary approach to medical challenges. The institution actively engages in clinical trials to enhance treatment options and improve patient outcomes, while promoting collaboration among healthcare professionals, researchers, and academic institutions globally. With a commitment to excellence and a focus on translational medicine, AMC-UvA plays a pivotal role in shaping the future of healthcare.

Locations

Amsterdam, , Netherlands

Patients applied

0 patients applied

Trial Officials

David MP van Meenen, MD, MSc

Study Director

Department of Intensive Care, Academic Medical Center, University of Amsterdam

Marcus J Schultz, MD, PhD

Principal Investigator

Department of Intensive Care, Academic Medical Center, University of Amsterdam

Marcello Gama de Abreu, MD, PhD

Study Chair

Department of Anesthesiology and Intensive Care Medicine, University Hospital Carl Gustav Carus, Technical University Dresden, Germany

Ary Serpa Neto, MD, MSc

Study Chair

Department of Intensive Care, Academic Medical Center, University of Amsterdam, The Netherlands

Paolo Pelosi, MD, PhD

Principal Investigator

Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Italy

Jitske R Rogmans

Principal Investigator

Department of Intensive Care, Academic Medical Center, University of Amsterdam

Lennard HL Pennekamp

Principal Investigator

Department of Intensive Care, Academic Medical Center, University of Amsterdam

Frank C Dullemeijer

Principal Investigator

Department of Intensive Care, Academic Medical Center, University of Amsterdam

Marco Maggiorini, MD, PhD

Principal Investigator

Department of Intensive Care, Universitatsspital, Zurich

Dominik Novotni, MD, PhD

Study Chair

Hamilton Medical AG

Alexandra Gerlach

Principal Investigator

Hamilton Medical AG

Job BM van Woensel, MD, PhD

Study Chair

Department of Intensive Care, Academic Medical Center, University of Amsterdam

Jean-Michel Arnal, MD, PhD

Study Chair

Department of Intensive Care, Intercommunal hospital, Toulon

Patricia Rocco, MD, PhD

Principal Investigator

Laboratory of pulmonary investigation, Federal University, Rio de Janeiro

Dave A Dongelmans, MD, PhD

Principal Investigator

Department of Intensive Care, Academic Medical Center, University of Amsterdam

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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