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A Validation/Interventional Study on Stress Index in Predicting Mechanical Stress in ARDS Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00465374
Recruitment Status : Unknown
Verified April 2007 by University of Turin, Italy.
Recruitment status was:  Recruiting
First Posted : April 25, 2007
Last Update Posted : April 25, 2007
Sponsor:
Information provided by:
University of Turin, Italy

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome, Adult Procedure: Change ventilatory parameters with stress index monitoring Phase 3

Detailed Description:
The study presents two parts : a preliminary validation study and a clinical study.

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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2002





Primary Outcome Measures :
  1. reduction of pulmonary inflammatory mediators


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT00465374


Contacts
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Contact: V. M. Ranieri, MD 00390116334001 marco.ranieri@unito.it
Contact: P. Terragni, MD 00390116334002 pierpaolo.terragni@unito.it

Locations
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Italy
University of Turin, Department of Anesthesia and Intensive Care Medicine Recruiting
Turin, Italy
Contact: V. M. Ranieri, MD    +390116334001    marco.ranieri@unito.it   
Contact: P. Terragni, MD    +390116334002    pierpaolo.terragni@unito.it   
Sponsors and Collaborators
University of Turin, Italy
Investigators
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Study Director: V. M. Ranieri, MD University of Turin, Italy
Principal Investigator: P. Terragni, MD University of Turin, Italy
Publications:
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ClinicalTrials.gov Identifier: NCT00465374    
Other Study ID Numbers: PRN60ANRA04
First Posted: April 25, 2007    Key Record Dates
Last Update Posted: April 25, 2007
Last Verified: April 2007
Keywords provided by University of Turin, Italy:
ARDS
Pressure/time curve
Stress Index
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury