Does Automated Closed-Loop Ventilation Reduce the DRiving Pressure Levels in Patients With ARDS (AiRDRoP) - a Single-Center Crossover Study and Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Transpulmonary driving pressure level
Study Overview
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.
Detailed Description
- Objective:
The objective of this crossover study and randomized controlled trial (RCT) is to compare ΔP levels during INTELLiVENT®- adaptive support ventilation (ASV) with conventional lung protective ventilation in the acute and sub-acute phase of moderate or severe ARDS.
- Study design:
Single center crossover study (in the acute phase) and RCT (in the sub-acute phase).
- Study population:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Conventional lung protective ventilation
Use of conventional lung protective ventilation, according to the ARDSnet guidelines
Intervention: Conventional lung protective ventilation (Other)
INTELLiVENT-ASV
Use of INTELLiVENT-ASV
Intervention: INTELLiVENT-ASV (Device)
Outcomes
Primary Outcomes
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 Outcomes
- Ppeak level(during the course of mechanical ventilation (max. 7 days))
- spO2(during the course of mechanical ventilation (max. 7 days))
- pH(during the course of mechanical ventilation (max. 7 days))
- Respiratory system driving pressure level(during the course of mechanical ventilation (max. 7 days))
- VCO2(during the course of mechanical ventilation (max. 7 days))
- Tidal volume(during the course of mechanical ventilation (max. 7 days))
- FiO2(during the course of mechanical ventilation (max. 7 days))
- PaCO2(during the course of mechanical ventilation (max. 7 days))
- PaO2(during the course of mechanical ventilation (max. 7 days))
- HCO3(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))
- RRset(during the course of mechanical ventilation (max. 7 days))
- RRmeasured(during the course of mechanical ventilation (max. 7 days))
- etCO2(during the course of mechanical ventilation (max. 7 days))
- saO2(during the course of mechanical ventilation (max. 7 days))
- Time spent at high driving pressure(during the course of mechanical ventilation (max. 7 days))
Investigators
Prof. Dr. Marcus J. Schultz
Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)