NCT03211494

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 7, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

November 3, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

March 5, 2019

Status Verified

March 1, 2019

Enrollment Period

1.3 years

First QC Date

July 6, 2017

Last Update Submit

March 4, 2019

Conditions

ARDS

Keywords

Mechanical ventilationDriving pressureClosed-loop ventilationEsophageal catheter

Outcome Measures

Primary Outcomes (1)

  • Transpulmonary driving pressure level

    The driving pressure of the lungs system, difference between end-inspiratory and end-expiratory pressure

    during the course of mechanical ventilation (max. 7 days)

Secondary Outcomes (17)

  • Respiratory system driving pressure level

    during the course of mechanical ventilation (max. 7 days)

  • Tidal volume

    during the course of mechanical ventilation (max. 7 days)

  • PEEP level

    during the course of mechanical ventilation (max. 7 days)

  • Pplat level

    during the course of mechanical ventilation (max. 7 days)

  • Ppeak level

    during the course of mechanical ventilation (max. 7 days)

  • +12 more secondary outcomes

Study Arms (2)

Conventional lung protective ventilation

ACTIVE COMPARATOR

Use of conventional lung protective ventilation, according to the ARDSnet guidelines

Other: Conventional lung protective ventilation

INTELLiVENT-ASV

ACTIVE COMPARATOR

Use of INTELLiVENT-ASV

Device: INTELLiVENT-ASV

Interventions

INTELLiVENT-ASVDEVICE

INTELLiVENT-ASV, with software 2.60

Also known as: automated closed-loop ventilation
INTELLiVENT-ASV
Conventional lung protective ventilationOTHER

Lung protective ventilation according to the ARDSnet guidelines

Conventional lung protective ventilation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Amsterdam, Netherlands

Location

Related Publications (1)

  • Buiteman-Kruizinga LA, van Meenen DMP, Bos LDJ, van der Heiden PLJ, Paulus F, Schultz MJ. A closed-loop ventilation mode that targets the lowest work and force of breathing reduces the transpulmonary driving pressure in patients with moderate-to-severe ARDS. Intensive Care Med Exp. 2023 Jul 14;11(1):42. doi: 10.1186/s40635-023-00527-1.

    PMID: 37442844DERIVED

Study Officials

  • David MP van Meenen, MD, MSc

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

    STUDY DIRECTOR

  • Marcus J Schultz, MD, PhD

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

    PRINCIPAL INVESTIGATOR

  • Marcello Gama de Abreu, MD, PhD

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

    STUDY CHAIR

  • Ary Serpa Neto, MD, MSc

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

    STUDY CHAIR

  • Paolo Pelosi, MD, PhD

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

    PRINCIPAL INVESTIGATOR

  • Jitske R Rogmans

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

    PRINCIPAL INVESTIGATOR

  • Lennard HL Pennekamp

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

    PRINCIPAL INVESTIGATOR

  • Frank C Dullemeijer

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

    PRINCIPAL INVESTIGATOR

  • Marco Maggiorini, MD, PhD

    Department of Intensive Care, Universitatsspital, Zurich

    PRINCIPAL INVESTIGATOR

  • Dominik Novotni, MD, PhD

    Hamilton Medical AG

    STUDY CHAIR

  • Alexandra Gerlach

    Hamilton Medical AG

    PRINCIPAL INVESTIGATOR

  • Job BM van Woensel, MD, PhD

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

    STUDY CHAIR

  • Jean-Michel Arnal, MD, PhD

    Department of Intensive Care, Intercommunal hospital, Toulon

    STUDY CHAIR

  • Patricia Rocco, MD, PhD

    Laboratory of pulmonary investigation, Federal University, Rio de Janeiro

    PRINCIPAL INVESTIGATOR

  • Dave A Dongelmans, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 6, 2017

First Posted

July 7, 2017

Study Start

November 3, 2017

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

March 5, 2019

Record last verified: 2019-03

Locations

NL(1)