Evaluation of the Lung Recruitment and End-expiratory Lung Collapse in Acute Respiratory Distress Syndrome (ARDS)

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ClinicalTrials.gov Identifier: NCT01670747

Recruitment Status : Completed

First Posted : August 22, 2012

Last Update Posted : March 19, 2015

Sponsor:

Information provided by (Responsible Party):

Davide Chiumello, Policlinico Hospital

Study Description

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).

Condition or disease	Intervention/treatment
ARDS: Acute Respiratory Distress Syndrome	Radiation: Chest computed tomography

Study Design

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Study Type :	Observational
Estimated Enrollment :	30 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Evaluation of the Lung Recruitment and End-expiratory Lung Collapse in Patients With Acute Respiratory Distress Syndrome
Study Start Date :	September 2012
Actual Primary Completion Date :	March 2015
Actual Study Completion Date :	March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Collapsed Lung

Genetic and Rare Diseases Information Center resources: Respiratory Distress Syndrome, Infant Acute Respiratory Distress Syndrome

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
ARDS Sedated and mechanically ventilated patients admitted to ICU	Radiation: Chest computed tomography

Outcome Measures

Primary Outcome Measures :

Computer Tomography (CT) scan lung recruitment and CT lung weight [ Time Frame: Study day (day 1) ]
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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients admitted to ICU with diagnosis of ARDS who required mechanical ventilation

Criteria

Inclusion Criteria:

Clinical diagnosis of acute lung injury/ acute respiratory distress syndrome
Mechanical ventilation

Exclusion Criteria:

Clinical diagnosis of chronic obstructive pulmonary disease
Clinical diagnosis of pneumothorax
Haemodynamic instability

Contacts and Locations

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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): NCT01670747

Locations

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Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milano, Italy, 20122

Sponsors and Collaborators

Policlinico Hospital

Investigators

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Principal Investigator:	Chiumello Davide, MD	Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

More Information

Publications:

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.

Caironi 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Cressoni 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.

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Responsible Party:	Davide Chiumello, MD, Policlinico Hospital
ClinicalTrials.gov Identifier:	NCT01670747
Other Study ID Numbers:	201208
First Posted:	August 22, 2012 Key Record Dates
Last Update Posted:	March 19, 2015
Last Verified:	March 2015

Additional relevant MeSH terms:

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Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Pulmonary Atelectasis Syndrome Disease Pathologic Processes	Lung Diseases Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Lung Injury

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