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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00465374 |
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Date of registration:
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24/04/2007 |
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Primary sponsor: |
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Public title:
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A Validation/Interventional Study on Stress Index in Predicting Mechanical Stress in ARDS Patients
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Scientific title:
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Date of first enrolment:
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October 2002 |
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Target sample size:
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00465374 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Italy
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Contacts
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Name:
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V. M. Ranieri, MD |
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Address:
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Telephone:
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+390116334001 |
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Email:
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marco.ranieri@unito.it |
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Affiliation:
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Name:
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V. M. Ranieri, MD |
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Address:
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Telephone:
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00390116334001 |
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Email:
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marco.ranieri@unito.it |
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Affiliation:
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Name:
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P. Terragni, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Turin |
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Name:
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V. M. Ranieri, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Turin |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age = 18 years
- Diagnosis of ARDS based on American-European Consensus Conference criteria
Exclusion Criteria:
- >3 days since ARDS criteria were met and mechanical ventilation was started
- History of ventricular fibrillation or tachyarrhythmia, unstable angina or
myocardial infarction within preceding month
- Pre-existing chronic obstructive pulmonary disease
- Major chest wall abnormalities
- Chest tube with persistent air leak
- Abdominal distension
- Body mass index >30
- Pregnancy
- Known intracranial abnormality
- Enrollment in another interventional study
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Respiratory Distress Syndrome, Adult
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Intervention(s)
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Procedure: Change ventilatory parameters with stress index monitoring
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Primary Outcome(s)
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reduction of pulmonary inflammatory mediators
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Secondary ID(s)
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PRN60ANRA04
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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