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

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ClinicalTrials.gov Identifier: NCT03211494
Recruitment Status : Terminated (Unexpected low recruitment rate)
First Posted : July 7, 2017
Last Update Posted : March 5, 2019
Sponsor:
Collaborator:
Hamilton Medical AG
Information provided by (Responsible Party):
Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.


Condition or disease Intervention/treatment Phase
ARDS Device: INTELLiVENT-ASV Other: Conventional lung protective ventilation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Does Automated Closed-Loop Ventilation Reduce the DRiving Pressure Levels in Patients With ARDS (AiRDRoP) - a Single-Center Crossover Study and Randomized Controlled Trial
Actual Study Start Date : November 3, 2017
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : March 1, 2019

Arm Intervention/treatment
Active Comparator: Conventional lung protective ventilation
Use of conventional lung protective ventilation, according to the ARDSnet guidelines
Other: Conventional lung protective ventilation
Lung protective ventilation according to the ARDSnet guidelines

Active Comparator: INTELLiVENT-ASV
Use of INTELLiVENT-ASV
Device: INTELLiVENT-ASV
INTELLiVENT-ASV, with software 2.60
Other Name: automated closed-loop ventilation




Primary Outcome Measures :
  1. Transpulmonary driving pressure level [ Time Frame: during the course of mechanical ventilation (max. 7 days) ]
    The driving pressure of the lungs system, difference between end-inspiratory and end-expiratory pressure


Secondary Outcome Measures :
  1. Respiratory system driving pressure level [ Time Frame: during the course of mechanical ventilation (max. 7 days) ]
    The driving pressure of the respiratory system, difference between Pplat and PEEP

  2. Tidal volume [ Time Frame: during the course of mechanical ventilation (max. 7 days) ]
    Volume of a breath

  3. PEEP level [ Time Frame: during the course of mechanical ventilation (max. 7 days) ]
    Positive end-expiratory pressure

  4. Pplat level [ Time Frame: during the course of mechanical ventilation (max. 7 days) ]
    Plateau pressure

  5. Ppeak level [ Time Frame: during the course of mechanical ventilation (max. 7 days) ]
    Peak pressure

  6. RRset [ Time Frame: during the course of mechanical ventilation (max. 7 days) ]
    set respiratory rate

  7. RRmeasured [ Time Frame: during the course of mechanical ventilation (max. 7 days) ]
    measured respiratory rate

  8. FiO2 [ Time Frame: during the course of mechanical ventilation (max. 7 days) ]
    Fraction of inspired oxygen

  9. etCO2 [ Time Frame: during the course of mechanical ventilation (max. 7 days) ]
    end tidal carbondioxide

  10. spO2 [ Time Frame: during the course of mechanical ventilation (max. 7 days) ]
    peripheral oxygen saturation

  11. VCO2 [ Time Frame: during the course of mechanical ventilation (max. 7 days) ]
    volume of expired oxygen

  12. PaCO2 [ Time Frame: during the course of mechanical ventilation (max. 7 days) ]
    Partial pressure of arterial carbondioxide

  13. PaO2 [ Time Frame: during the course of mechanical ventilation (max. 7 days) ]
    Partial pressure of arterial oxygen

  14. saO2 [ Time Frame: during the course of mechanical ventilation (max. 7 days) ]
    arterial oxygen saturation

  15. pH [ Time Frame: during the course of mechanical ventilation (max. 7 days) ]
    acidity of the arterial blood

  16. HCO3 [ Time Frame: during the course of mechanical ventilation (max. 7 days) ]
    Bicarbonate

  17. Time spent at high driving pressure [ Time Frame: during the course of mechanical ventilation (max. 7 days) ]
    Time spent at a driving pressure of more than 14 cm H2O



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT03211494


Locations
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Netherlands
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Amsterdam, Netherlands
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Hamilton Medical AG
Investigators
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Study Director: David MP van Meenen, MD, MSc Department of Intensive Care, Academic Medical Center, University of Amsterdam
Principal Investigator: Marcus J Schultz, MD, PhD Department of Intensive Care, Academic Medical Center, University of Amsterdam
Study Chair: 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
Principal Investigator: 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
Study Chair: Dominik Novotni, MD, PhD Hamilton Medical AG
Principal Investigator: Alexandra Gerlach Hamilton Medical AG
Study Chair: 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
Principal Investigator: 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
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Responsible Party: Prof. Dr. Marcus J. Schultz, Principal Investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT03211494    
Other Study ID Numbers: AiRDRoP
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Mechanical ventilation
Driving pressure
Closed-loop ventilation
Esophageal catheter