Evaluation of the Lung Recruitment and End-expiratory Lung Collapse in Acute Respiratory Distress Syndrome (ARDS)
1 other identifier
observational
30
1 country
1
Brief Summary
In this study gas-exchange and respiratory mechanics variations to PEEP change will be correlated to CT lung morphological modifications assessed at different airway pressures (5, 15, 30 and 45 cmH2O).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2012
Typical duration for all trials
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
First Submitted
Initial submission to the registry
August 14, 2012
CompletedFirst Posted
Study publicly available on registry
August 22, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedMarch 19, 2015
March 1, 2015
2.5 years
August 14, 2012
March 18, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Computer Tomography (CT) scan lung recruitment and CT lung weight
Aim of the study is to determine the relationship between the opening pressures (recruitment) and closing pressures (PEEP) in order to prevent the opening and closing of the lung parenchyma
Study day (day 1)
Study Arms (1)
ARDS
Sedated and mechanically ventilated patients admitted to ICU
Interventions
Eligibility Criteria
Patients admitted to ICU with diagnosis of ARDS who required mechanical ventilation
You may qualify if:
- Clinical diagnosis of acute lung injury/ acute respiratory distress syndrome
- Mechanical ventilation
You may not qualify if:
- Clinical diagnosis of chronic obstructive pulmonary disease
- Clinical diagnosis of pneumothorax
- Haemodynamic instability
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
Related Publications (3)
Gattinoni L, Caironi P, Cressoni M, Chiumello D, Ranieri VM, Quintel M, Russo S, Patroniti N, Cornejo R, Bugedo G. Lung recruitment in patients with the acute respiratory distress syndrome. N Engl J Med. 2006 Apr 27;354(17):1775-86. doi: 10.1056/NEJMoa052052.
PMID: 16641394BACKGROUNDCaironi P, Cressoni M, Chiumello D, Ranieri M, Quintel M, Russo SG, Cornejo R, Bugedo G, Carlesso E, Russo R, Caspani L, Gattinoni L. Lung opening and closing during ventilation of acute respiratory distress syndrome. Am J Respir Crit Care Med. 2010 Mar 15;181(6):578-86. doi: 10.1164/rccm.200905-0787OC. Epub 2009 Nov 12.
PMID: 19910610BACKGROUNDCressoni M, Chiumello D, Algieri I, Brioni M, Chiurazzi C, Colombo A, Colombo A, Crimella F, Guanziroli M, Tomic I, Tonetti T, Luca Vergani G, Carlesso E, Gasparovic V, Gattinoni L. Opening pressures and atelectrauma in acute respiratory distress syndrome. Intensive Care Med. 2017 May;43(5):603-611. doi: 10.1007/s00134-017-4754-8. Epub 2017 Mar 10.
PMID: 28283699DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chiumello Davide, MD
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
August 14, 2012
First Posted
August 22, 2012
Study Start
September 1, 2012
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
March 19, 2015
Record last verified: 2015-03