PRotective VENTilation in Patients Without ARDS

NCT02153294 | Completed DMC

• 2 other identifiers: PReVENT-NL80-83700-98-42001
• Study Type: interventional
• Target: 952
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator-free Days

Keywords

low tidal volume; high tidal volume; protective ventilation; ARDS

Outcome Measures

Primary Outcomes (1)

• Ventilator-free days

  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.

  first 28 days after start of ventilation

Secondary Outcomes (7)

• Intensive care unit length of stay

  first 90 days after start of ventilation

• Hospital length of stay

  first 90 days after start of ventilation

• Cumulative use and duration of sedatives and neuromuscular blocking agents

  first 28 days after start of ventilation or discharge from intensive care

• ICU delirium

  first 28 days after start of ventilation or discharge from intensive care

• ICU- Acquired Weakness

  first 28 days after start of ventilation or discharge from intensive care

Study Arms (2)

Ventilation with lower tidal volumes

EXPERIMENTAL

Use of low tidal volume (4 to 6 ml/kg PBW) after intubation and during all mechanical ventilation

Procedure: low tidal volume

Ventilation with higher tidal volumes

OTHER

Use of high tidal volume (8 to 10 ml/kg PBW) after intubation and during all mechanical ventilation

Procedure: high tidal volume

Interventions

low tidal volume PROCEDURE

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

Ventilation with lower tidal volumes

high tidal volume PROCEDURE

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

Ventilation with higher tidal volumes

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Tergooi Hospital: collaborator
• Leiden University Medical Center: collaborator
• Gelre Hospitals: collaborator
• Amsterdam UMC, location VUmc: collaborator
• Westfries Hospital: collaborator

Study Sites (1)

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

Amsterdam, Netherlands

Location

Related Publications (3)

• van Meenen DMP, Algera AG, Schuijt MTU, Simonis FD, van der Hoeven SM, Neto AS, Abreu MG, Pelosi P, Paulus F, Schultz MJ; for the NEBULAE; PReVENT; RELAx investigators. Effect of mechanical power on mortality in invasively ventilated ICU patients without the acute respiratory distress syndrome: An analysis of three randomised clinical trials. Eur J Anaesthesiol. 2023 Jan 1;40(1):21-28. doi: 10.1097/EJA.0000000000001778. Epub 2022 Nov 18.

  PMID: 36398740 DERIVED

• Writing Group for the PReVENT Investigators; Simonis FD, Serpa Neto A, Binnekade JM, Braber A, Bruin KCM, Determann RM, Goekoop GJ, Heidt J, Horn J, Innemee G, de Jonge E, Juffermans NP, Spronk PE, Steuten LM, Tuinman PR, de Wilde RBP, Vriends M, Gama de Abreu M, Pelosi P, Schultz MJ. Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without ARDS: A Randomized Clinical Trial. JAMA. 2018 Nov 13;320(18):1872-1880. doi: 10.1001/jama.2018.14280.

  PMID: 30357256 DERIVED

• Simonis FD, Binnekade JM, Braber A, Gelissen HP, Heidt J, Horn J, Innemee G, de Jonge E, Juffermans NP, Spronk PE, Steuten LM, Tuinman PR, Vriends M, de Vreede G, de Wilde RB, Serpa Neto A, Gama de Abreu M, Pelosi P, Schultz MJ. PReVENT--protective ventilation in patients without ARDS at start of ventilation: study protocol for a randomized controlled trial. Trials. 2015 May 24;16:226. doi: 10.1186/s13063-015-0759-1.

  PMID: 26003545 DERIVED

Study Officials

• Marcus J Schultz, MD, PhD

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

  PRINCIPAL INVESTIGATOR

• Fabienne D Simonis, MD

  Academic Medical Center, University of Amsterdam, The Netherlands

  STUDY DIRECTOR

• 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

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Clinical Professor

Study Record Dates

• First Submitted: May 23, 2014
• First Posted: June 3, 2014
• Study Start: August 1, 2014
• Primary Completion: September 20, 2017
• Study Completion: November 18, 2017
• Last Updated: March 26, 2018

Record last verified: 2018-03

Locations

NL (1)