PRotective VENTilation in Patients Without ARDS

Summary

The purpose of this national multicentre randomized controlled trial is to compare a ventilation strategy using lower tidal volumes and higher respiratory rates with a ventilation strategy using higher tidal volumes and a lower respiratory rate in intubated and ventilated intensive care unit (ICU) patients without Acute Respiratory Distress Syndrome (ARDS) at start of ventilation.

Participating centres in The Netherlands will include a total of 952 adult patients admitted to intensive care units without ARDS. Patients are randomized and ventilated with either a strategy with lower tidal volumes (4 to 6 ml/kg predicted body weight (PBW)) or a strategy with higher tidal volumes (8 to 10 ml/kg PBW). Patients will be assessed every day until day 28 or discharge of the intensive care unit, whichever comes first, on day 28 and on day 90. Primary endpoint is the number of ventilator-free days at day 28. Secondary endpoints are ICU- and hospital length of stay (LOS) and - mortality, the incidence of development of ARDS, pneumonia, atelectasis, and pneumothorax, the cumulative use and duration of sedatives, and neuromuscular blocking agents, incidences of ICU delirium and ICU acquired weakness, patient-ventilator asynchrony and the need for decreasing of instrumental dead space.

Conditions

• Ventilator-free Days

Interventions

PROCEDURE

low tidal volume

Patients are randomized and ventilated with a low tidal volume (4-6 ml/kg PBW)

PROCEDURE

high tidal volume

Patients are randomized and ventilated with a high tidal volume (8-10 ml/kg PBW)

Sponsors & Collaborators

• Tergooi Hospital

  collaborator OTHER

• Leiden University Medical Center

  collaborator OTHER

• Gelre Hospitals

  collaborator OTHER

• Amsterdam UMC, location VUmc

  collaborator OTHER

• Westfries Hospital

  collaborator OTHER

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

  lead OTHER

Principal Investigators

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

• Fabienne D Simonis, MD · Academic Medical Center, University of Amsterdam, The Netherlands

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

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

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

• Janneke Horn, MD, PhD · Department of Intensive Care, Academic Medical Center, University of Amsterdam, The Netherlands

• Nicole P Juffermans, MD, PhD · Department of Intensive Care, Academic Medical Center, University of Amsterdam, The Netherlands

• Jan M Binnekade, PhD · Department of Intensive Care, Academic Medical Center, University of Amsterdam, The Netherlands

• Gerard Innemee, MD · Tergooi, Hilversum, The Netherlands

• Evert de Jonge, MD, PhD · Leiden University Medical Center, Leiden, The Netherlands

• Peter E Spronk, MD, PhD · Gelre Hospitals, Apeldoorn, The Netherlands

• Pieter Roel Tuinman, MD, PhD · VU Medical Center, Amsterdam, The Netherlands

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-08-31

Primary Completion

2017-09-20

Completion

2017-11-18

Countries

• Netherlands

Study Locations