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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2007 by University of Turin, Italy.
Recruitment status was:  Recruiting
Information provided by:
University of Turin, Italy Identifier:
First received: April 24, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
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 Intervention Phase
Respiratory Distress Syndrome, Adult Procedure: Change ventilatory parameters with stress index monitoring Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by University of Turin, Italy:

Primary Outcome Measures:
  • reduction of pulmonary inflammatory mediators

Study Start Date: October 2002
Detailed Description:
The study presents two parts : a preliminary validation study and a clinical study.

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00465374

Contact: V. M. Ranieri, MD 00390116334001
Contact: P. Terragni, MD 00390116334002

University of Turin, Department of Anesthesia and Intensive Care Medicine Recruiting
Turin, Italy
Contact: V. M. Ranieri, MD    +390116334001   
Contact: P. Terragni, MD    +390116334002   
Sponsors and Collaborators
University of Turin, Italy
Study Director: V. M. Ranieri, MD University of Turin, Italy
Principal Investigator: P. Terragni, MD University of Turin, Italy
  More Information

Publications: Identifier: NCT00465374     History of Changes
Other Study ID Numbers: PRN60ANRA04
Study First Received: April 24, 2007
Last Updated: April 24, 2007

Keywords provided by University of Turin, Italy:
Pressure/time curve
Stress Index

Additional relevant MeSH terms:
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 processed this record on September 25, 2017