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Hemodynamic Effects of PEEP in ARDS

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ClinicalTrials.gov Identifier: NCT03896802
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Davide Chiumello, University of Milan

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)

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Mechanical Ventilation ARDS, Human Procedure: Physiological assesment Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Hemodynamic Effects of PEEP in Patients With ARDS
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019


Arm Intervention/treatment
Experimental: Low PEEP
PEEP 5 cmH2O
Procedure: Physiological assesment
  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.

Experimental: High PEEP
PEEP 15 cmH2O
Procedure: Physiological assesment
  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.




Primary Outcome Measures :
  1. Cardiac Output [ Time Frame: Study 1 day ]
    Cardiac output (in l/min) will be measured by transpulmonary thermodilution and arterial pulse contour analysis


Secondary Outcome Measures :
  1. Transmural central venous pressure [ Time Frame: Study 1 day ]
    Measured and CVP minus esophageal pressure

  2. Mean systemic filling pressure [ Time Frame: Study 1 day ]
    Measured with the respiratory hold method



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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:

  • 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.

Exclusion Criteria:

  • Patients with barotrauma and with clinical evidence of intrinsic PEEP will be excluded.

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): NCT03896802


Contacts
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Contact: Davide Chiumello +390281844020 chiumello@libero.it
Contact: Davide Chiumello chiumello@libero.it

Locations
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Italy
Ospedale San Paolo - Polo Universitario, ASST Santi Paolo e Carlo Recruiting
Milano, MI, Italy, 20142
Contact: Davide Chiumello    +390281844020    chiumello@libero.it   
Sponsors and Collaborators
University of Milan

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Responsible Party: Davide Chiumello, Director of Intensive Care, University of Milan
ClinicalTrials.gov Identifier: NCT03896802     History of Changes
Other Study ID Numbers: ARDS-HEMO
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury