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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 because the information has not been verified recently.
Verified April 2007 by University of Turin, Italy.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT00465374
First received: April 24, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00465374

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

Locations
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
Study Director: V. M. Ranieri, MD University of Turin
Principal Investigator: P. Terragni, MD University of Turin
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00465374     History of Changes
Other Study ID Numbers: PRN60ANRA04
Study First Received: April 24, 2007
Last Updated: April 24, 2007
Health Authority: Italy: Ministry of Health

Keywords provided by University of Turin, Italy:
ARDS
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

ClinicalTrials.gov processed this record on May 19, 2013