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Gas Exchange and CT Effects of PEEP in ARDS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04067154
Recruitment Status : Completed
First Posted : August 26, 2019
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Mauro Panigada, Policlinico Hospital

Brief Summary:
The study aims to investigate the association between effects of PEEP on gas exchange model parameters and CT scan results

Condition or disease Intervention/treatment Phase
ARDS Diagnostic Test: ALPE Not Applicable

Detailed Description:
In ARDS patients on mechanical ventilation, we will compare model-based estimation of gas exchange parameters (shunt, ventilation/perfusion mismatch) with CT-based estimation of effects of low and high PEEP

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Does a Bedside Method for Describing Functional Gas Exchange Compare Well With Anatomical Description Via CT Scans, and Could it Predict the Effects of Recruitment and Ventilation/Perfusion Mismatch Improvement
Actual Study Start Date : August 1, 2012
Actual Primary Completion Date : August 1, 2014
Actual Study Completion Date : August 1, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ALPE-TAC
ARDS patients on mechanical ventilation. Measurement of CT scan at PEEP of 5, 20 and 45 cm H2O to evaluate potential for recruitment and measurement of gas exchange by model-based method and FiO2 titration at PEEP of 5 and 20 cm H2O
Diagnostic Test: ALPE
Measurement of CT scan at PEEP of 5, 20 and 45 cm H2O Measurement of gas exchange by model-based method and FiO2 titration at PEEP of 5 and 20 cm H2O




Primary Outcome Measures :
  1. Gas Exchange and lung recruitability at diferent PEEP levels [ Time Frame: Approximately two hours ]
    Gas exchange (At PEEP 5 and 20 cm H2O), CT scan (At PEEP 5, 20 and 45 cm H2O)


Secondary Outcome Measures :
  1. Physiologic Parameter 1 [ Time Frame: Approximately two hours ]
    Hemodynamic assessment at different PEEP levels

  2. Physiologic Parameter 2 [ Time Frame: Approximately two hours ]
    Respiratory mechanics at different PEEP levels



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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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:

- ARDS patients requiring mechanical ventilation

Exclusion Criteria:

  • <18 years old
  • Requirement of extracorporal life support
  • Hemodynamic instability
  • Barotrauma

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): NCT04067154


Locations
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Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milano, MI, Italy, 20122
Sponsors and Collaborators
Policlinico Hospital
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Responsible Party: Mauro Panigada, Does a bedside method for describing functional gas exchange compare well with anatomical description via CT scans, and could it predict the effects of recruitment and ventilation/perfusion mismatch improvement., Policlinico Hospital
ClinicalTrials.gov Identifier: NCT04067154    
Other Study ID Numbers: 2425
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No