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| Tracking Information | |||||
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| First Received Date ICMJE | August 31, 2005 | ||||
| Last Updated Date | September 24, 2008 | ||||
| Start Date ICMJE | March 2005 | ||||
| Primary Completion Date | March 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Specific elastance [ Time Frame: 5 minutes ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Specific elastance | ||||
| Change History | Complete list of historical versions of study NCT00143468 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Specific Elastance in Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) Patients | ||||
| Official Title ICMJE | The Specific Elastance in Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) Patients: Barotrauma and Volutrauma | ||||
| Brief Summary | The investigators aim to study the specific elastance in ALI/ARDS patients during invasive mechanical ventilation. |
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| Detailed Description | In sedated and paralyzed ALI/ARDS patients, we studied the specific elastance and also, we compared the specific elastance to healthy subjects during invasive mechanical ventilation. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Placebo Control, Single Group Assignment, Safety Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Behavioral: mechanical ventilation | ||||
| Study Arms / Comparison Groups | Experimental: ALI/ARDS patients and healthy subjects | ||||
| Publications * | Chiumello D, Carlesso E, Cadringher P, Caironi P, Valenza F, Polli F, Tallarini F, Cozzi P, Cressoni M, Colombo A, Marini JJ, Gattinoni L. Lung stress and strain during mechanical ventilation for acute respiratory distress syndrome. Am J Respir Crit Care Med. 2008 Aug 15;178(4):346-55. Epub 2008 May 1. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 100 | ||||
| Completion Date | May 2008 | ||||
| Primary Completion Date | March 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 16 Years to 90 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Italy | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00143468 | ||||
| Responsible Party | Davide Chiumello, Policlinico Hospital | ||||
| Study ID Numbers ICMJE | 1160 | ||||
| Study Sponsor ICMJE | Policlinico Hospital | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Policlinico Hospital | ||||
| Verification Date | September 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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