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PRotective VENTilation in Patients Without ARDS (PReVENT-NL)

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ClinicalTrials.gov Identifier: NCT02153294
Recruitment Status : Completed
First Posted : June 3, 2014
Last Update Posted : March 26, 2018
Sponsor:
Collaborators:
Tergooi Hospital
Leiden University Medical Center
Gelre Hospitals
VU University Medical Center
Westfries Hospital
Information provided by (Responsible Party):
Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief 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.


Condition or disease Intervention/treatment Phase
Ventilator-free Days Procedure: low tidal volume Procedure: high tidal volume Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 952 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PRotective VENTilation in Patients Without ARDS at Start of Ventilation - PReVENT, a Randomized Controlled Trial
Study Start Date : August 2014
Actual Primary Completion Date : September 20, 2017
Actual Study Completion Date : November 18, 2017

Arm Intervention/treatment
Experimental: Ventilation with lower tidal volumes
Use of low tidal volume (4 to 6 ml/kg PBW) after intubation and during all mechanical ventilation
Procedure: low tidal volume
Patients are randomized and ventilated with a low tidal volume (4-6 ml/kg PBW)

Ventilation with higher tidal volumes
Use of high tidal volume (8 to 10 ml/kg PBW) after intubation and during all mechanical ventilation
Procedure: high tidal volume
Patients are randomized and ventilated with a high tidal volume (8-10 ml/kg PBW)




Primary Outcome Measures :
  1. Ventilator-free days [ Time Frame: first 28 days after start of ventilation ]
    The number of ventilator-free days, defined as the number of days from day 1 to day 28 on which a patient breathes without assistance, if the period of unassisted breathing lasted at least 24 consecutive hours.


Secondary Outcome Measures :
  1. Intensive care unit length of stay [ Time Frame: first 90 days after start of ventilation ]
  2. Hospital length of stay [ Time Frame: first 90 days after start of ventilation ]
  3. Cumulative use and duration of sedatives and neuromuscular blocking agents [ Time Frame: first 28 days after start of ventilation or discharge from intensive care ]
  4. ICU delirium [ Time Frame: first 28 days after start of ventilation or discharge from intensive care ]
    Development of delirium according to the Confusion Assessment Method for intensive care unit (CAM-ICU)

  5. ICU- Acquired Weakness [ Time Frame: first 28 days after start of ventilation or discharge from intensive care ]
    Development of ICU-acquired weakness using the Medical Research Council (MRC) score and grip strength assessment

  6. Mortality [ Time Frame: first 90 days after start of ventilation ]
    Any death during ICU-, or hospital-stay and within 90 days

  7. Pulmonary complications [ Time Frame: first 28 days after start of ventilation or discharge from intensive care ]
    Development of ARDS according to the Berlin definition, pulmonary infection, atelectases and pneumothorax



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Admission to an ICU participating in this trial
  • Need for intubation
  • Within 1 hour of admission from the operation room or emergency room (if still intubated and ventilated), or within 1 hour of start of invasive ventilation in the ICU
  • An expected duration of ventilation > 24 hours

Exclusion Criteria:

  • Age less than 18 years
  • Patients previously randomized in PReVENT
  • Patients participating in other interventional trials
  • Patients with a clinical diagnosis of ARDS according to the Berlin definition
  • Patients with a PaO2/FiO2 < 200 mm Hg in whom hypoxia is presumably not caused by cardiac failure or fluid overload
  • Invasive ventilation longer than 12 hours directly preceding admission
  • Patients with suspected or confirmed pregnancy
  • Patients with increased and uncontrollable intracranial pressure (of ≥18 mmHg)
  • Patients with GOLD classification III or IV chronic obstructive pulmonary disease (COPD)
  • Patients with asthmatic status
  • Patients with premorbid restrictive pulmonary disease (evidence of chronic interstitial infiltration on previous chest radiographs)
  • Patients with new proven pulmonary thrombo-embolism
  • Patients with any previous pneumectomy or lobectomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153294


Locations
Netherlands
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Amsterdam, Netherlands
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Tergooi Hospital
Leiden University Medical Center
Gelre Hospitals
VU University Medical Center
Westfries Hospital
Investigators
Principal Investigator: Marcus J Schultz, MD, PhD Department of Intensive Care, Academic Medical Center, University of Amsterdam
Study Director: Fabienne D Simonis, MD Academic Medical Center, University of Amsterdam, The Netherlands
Study Chair: Marcelo Gama de Abreu, MD, PhD Department of Anesthesiology and Intensive Care Medicine, University Hospital Carl Gustav Carus, Technical University Dresden, Germany
Study Chair: Paolo Pelosi, MD, PhD Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Italy
Study Chair: Ary Serpa Neto, MD, MSc Department of Intensive Care, Academic Medical Center, University of Amsterdam, The Netherlands
Principal Investigator: Janneke Horn, MD, PhD Department of Intensive Care, Academic Medical Center, University of Amsterdam, The Netherlands
Principal Investigator: Nicole P Juffermans, MD, PhD Department of Intensive Care, Academic Medical Center, University of Amsterdam, The Netherlands
Principal Investigator: Jan M Binnekade, PhD Department of Intensive Care, Academic Medical Center, University of Amsterdam, The Netherlands
Principal Investigator: Gerard Innemee, MD Tergooi, Hilversum, The Netherlands
Principal Investigator: Evert de Jonge, MD, PhD Leiden University Medical Center, Leiden, The Netherlands
Principal Investigator: Peter E Spronk, MD, PhD Gelre Hospitals, Apeldoorn, The Netherlands
Principal Investigator: Pieter Roel Tuinman, MD, PhD VU Medical Center, Amsterdam, The Netherlands

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Marcus J. Schultz, Principal Investigator and Clinical Professor, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02153294     History of Changes
Other Study ID Numbers: PReVENT-NL
80-83700-98-42001 ( Other Grant/Funding Number: 2013/16475/ZONMW )
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: March 2018

Keywords provided by Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
low tidal volume
high tidal volume
protective ventilation
ARDS