- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00465374
A Validation/Interventional Study on Stress Index in Predicting Mechanical Stress in ARDS Patients
April 24, 2007 updated by: University of Turin, Italy
30% of ARDS patients ventilated according to NIH protocol presents CT scan evidence of hyperinflation.
Functional analysis of pressure-time curve (Stress Index=SI) has been shown to identify this condition in experimental settings.
We tested the hypothesis that the SI is an accurate predictor of mechanical stress due to overdistention in ARDS patients.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
The study presents two parts : a preliminary validation study and a clinical study.
Study Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: V. M. Ranieri, MD
- Phone Number: 00390116334001
- Email: marco.ranieri@unito.it
Study Contact Backup
- Name: P. Terragni, MD
- Phone Number: 00390116334002
- Email: pierpaolo.terragni@unito.it
Study Locations
-
-
-
Turin, Italy
- Recruiting
- University of Turin, Department of Anesthesia and Intensive Care Medicine
-
Contact:
- V. M. Ranieri, MD
- Phone Number: +390116334001
- Email: marco.ranieri@unito.it
-
Contact:
- P. Terragni, MD
- Phone Number: +390116334002
- Email: pierpaolo.terragni@unito.it
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
reduction of pulmonary inflammatory mediators
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: V. M. Ranieri, MD, University of Turin, Italy
- Principal Investigator: P. Terragni, MD, University of Turin, Italy
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ranieri VM, Zhang H, Mascia L, Aubin M, Lin CY, Mullen JB, Grasso S, Binnie M, Volgyesi GA, Eng P, Slutsky AS. Pressure-time curve predicts minimally injurious ventilatory strategy in an isolated rat lung model. Anesthesiology. 2000 Nov;93(5):1320-8. doi: 10.1097/00000542-200011000-00027.
- Grasso S, Terragni P, Mascia L, Fanelli V, Quintel M, Herrmann P, Hedenstierna G, Slutsky AS, Ranieri VM. Airway pressure-time curve profile (stress index) detects tidal recruitment/hyperinflation in experimental acute lung injury. Crit Care Med. 2004 Apr;32(4):1018-27. doi: 10.1097/01.ccm.0000120059.94009.ad.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2002
Study Registration Dates
First Submitted
April 24, 2007
First Submitted That Met QC Criteria
April 24, 2007
First Posted (Estimate)
April 25, 2007
Study Record Updates
Last Update Posted (Estimate)
April 25, 2007
Last Update Submitted That Met QC Criteria
April 24, 2007
Last Verified
April 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRN60ANRA04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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