Effects of Variable Ventilation on Respiratory System of Acute Respiratory Distress Syndrome (ARDS) Patients
This study is ongoing, but not recruiting participants.
Sponsor:
Policlinico Hospital
Information provided by (Responsible Party):
Davide Chiumello, Policlinico Hospital
ClinicalTrials.gov Identifier:
NCT00202098
First received: September 12, 2005
Last updated: November 30, 2011
Last verified: November 2011
| Tracking Information | |||||
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| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | November 30, 2011 | ||||
| Start Date ICMJE | March 2005 | ||||
| Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Gas exchange and respiratory mechanics [ Time Frame: within the first 60 minutes from the ventilatory change ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00202098 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of Variable Ventilation on Respiratory System of Acute Respiratory Distress Syndrome (ARDS) Patients | ||||
| Official Title ICMJE | Effects of Variable Ventilation on Respiratory System of ARDS Patients | ||||
| Brief Summary | The purpose of this study is to determine the effects of variable ventilation on respiratory system of patients affected by acute respiratory distress syndrome. |
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| Detailed Description | In this interventional study we want to evaluate the effect of Variable ventilation (1) in patients with ARDS. Patients will be mechanically ventilated with Variable Ventilation (3 step with increased level of variability) and "traditional" CMV, for a total of 4 step. Each step lasts in 60 minutes. During this period we will record the gas exchange parameters and the mechanics of the respiratory system. 1. Arold S, Mora R, Lutchen K, et al. Variable ventilation improves lung mechanics and gas exchange in a rodent model of acute lung injury. Am J Resp Crit Care Med 2000; 165: 366-71. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | ARDS | ||||
| Intervention ICMJE | Procedure: Variable ventilation
Patients will be mechanically ventilated with Variable Ventilation (3 step with increased level of variability) and "traditional" CMV, for a total of 4 step. Each step lasts in 60 minutes. During this period the investigators will record the gas exchange parameters and the mechanics of the respiratory system. |
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| Study Arm (s) | Experimental: 1
ALI/ARDS patients
Intervention: Procedure: Variable ventilation |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 16 | ||||
| Estimated Completion Date | December 2012 | ||||
| Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Italy | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00202098 | ||||
| Other Study ID Numbers ICMJE | 11 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Davide Chiumello, Policlinico Hospital | ||||
| Study Sponsor ICMJE | Policlinico Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Policlinico Hospital | ||||
| Verification Date | November 2011 | ||||
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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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