Hemodynamic Effects of PEEP in ARDS
1 other identifier
interventional
16
1 country
1
Brief Summary
The purpose of this study is to assess the effect of different levels of PEEP on the cardiocirculatory system in patients affected by the acute respiratory distress syndrome (ARDS)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2018
Typical duration for not_applicable
1 active site
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
Study Start
First participant enrolled
January 1, 2018
CompletedFirst Submitted
Initial submission to the registry
March 28, 2019
CompletedFirst Posted
Study publicly available on registry
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedApril 2, 2019
March 1, 2019
2 years
March 28, 2019
March 29, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Cardiac Output
Cardiac output (in l/min) will be measured by transpulmonary thermodilution and arterial pulse contour analysis
Study 1 day
Secondary Outcomes (2)
Transmural central venous pressure
Study 1 day
Mean systemic filling pressure
Study 1 day
Study Arms (2)
Low PEEP
EXPERIMENTALPEEP 5 cmH2O
High PEEP
EXPERIMENTALPEEP 15 cmH2O
Interventions
1. Arterial and mixed venous blood gas analysis. 2. Alveolar and physiologic dead space via volumetric capnometry, as well as carbon dioxide (CO2) production, end-tidal CO2 and mixed expired CO2 3. Respiratory system (Crs), chest wall (Ccw) and lung (Cl) compliance measurement via an end-inspiratory and end-expiratory pause. 4. Arterial blood pressure, central venous pressure (CVP), heart rate, cardiac output through the arterial pulse contour and transpulmonary thermodilution methods (PiCCO technology). Global end-diastolic volume, Intra-thoracic blood volume, Extravascular lung water will also be assessed. Respiratory hold maneuvers (at PEEP, and +10, +15 and +20 cmH2O) will be performed and CVP and cardiac output will be measured in the last 3 s of the 12 s inspiratory hold. Venous return curve will constructed and the zero-flow pressure recorded as the mean systemic filling pressure. 5. Urine flow in 1h and determination of the fractional excretion of sodium and creatinine.
Eligibility Criteria
You may qualify if:
- All patients aged 18 or older and with a recent (\<48h) diagnosis of ARDS, undergoing invasive mechanical ventilation and in whom, due to the hemodynamic instability, cardiac output monitoring with an Arterial pulse contour analysis and transpulmonary thermodilution system (PiCCO technology, Pulsion Medical Systems, Germany) will be considered necessary, will be considered for enrolment.
You may not qualify if:
- Patients with barotrauma and with clinical evidence of intrinsic PEEP will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ospedale San Paolo - Polo Universitario, ASST Santi Paolo e Carlo
Milan, MI, 20142, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Intensive Care
Study Record Dates
First Submitted
March 28, 2019
First Posted
April 1, 2019
Study Start
January 1, 2018
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
April 2, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share