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

This study is not yet open for participant recruitment.

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Contacts and Locations

Verified July 2017 by Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Sponsor:

Collaborator:

Hamilton Medical AG

Information provided by (Responsible Party):

Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

ClinicalTrials.gov Identifier:

NCT03211494

First received: July 6, 2017

Last updated: NA

Last verified: July 2017

History: No changes posted

Purpose

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	Intervention
ARDS	Device: INTELLiVENT-ASV Other: Conventional lung protective ventilation


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: No masking 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

Further study details as provided by Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:

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:

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
Tidal volume [ Time Frame: during the course of mechanical ventilation (max. 7 days) ]
Volume of a breath
PEEP level [ Time Frame: during the course of mechanical ventilation (max. 7 days) ]
Positive end-expiratory pressure
Pplat level [ Time Frame: during the course of mechanical ventilation (max. 7 days) ]
Plateau pressure
Ppeak level [ Time Frame: during the course of mechanical ventilation (max. 7 days) ]
Peak pressure
RRset [ Time Frame: during the course of mechanical ventilation (max. 7 days) ]
set respiratory rate
RRmeasured [ Time Frame: during the course of mechanical ventilation (max. 7 days) ]
measured respiratory rate
FiO2 [ Time Frame: during the course of mechanical ventilation (max. 7 days) ]
Fraction of inspired oxygen
etCO2 [ Time Frame: during the course of mechanical ventilation (max. 7 days) ]
end tidal carbondioxide
spO2 [ Time Frame: during the course of mechanical ventilation (max. 7 days) ]
peripheral oxygen saturation
VCO2 [ Time Frame: during the course of mechanical ventilation (max. 7 days) ]
volume of expired oxygen
PaCO2 [ Time Frame: during the course of mechanical ventilation (max. 7 days) ]
Partial pressure of arterial carbondioxide
PaO2 [ Time Frame: during the course of mechanical ventilation (max. 7 days) ]
Partial pressure of arterial oxygen
saO2 [ Time Frame: during the course of mechanical ventilation (max. 7 days) ]
arterial oxygen saturation
pH [ Time Frame: during the course of mechanical ventilation (max. 7 days) ]
acidity of the arterial blood
HCO3 [ Time Frame: during the course of mechanical ventilation (max. 7 days) ]
Bicarbonate
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


Estimated Enrollment:	48
Anticipated Study Start Date:	August 2017
Estimated Study Completion Date:	September 2018
Estimated Primary Completion Date:	August 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03211494

Contacts


Contact: David MP van Meenen, MD, MSc	+31205666339	d.m.vanmeenen@amc.nl
Contact: Marcus J Schultz, MD, PhD	+31205662209	marcus.j.schultz@gmail.com

Sponsors and Collaborators

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

Hamilton Medical AG

Investigators


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

More Information


Responsible Party:	Prof. Dr. Marcus J. Schultz, Principal Investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:	NCT03211494 History of Changes
Other Study ID Numbers:	AiRDRoP
Study First Received:	July 6, 2017
Last Updated:	July 6, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided


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

ClinicalTrials.gov processed this record on July 11, 2017

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