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

Respiratory Distress Syndrome, Adult Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00465374
• Other study ID #: PRN60ANRA04
• Status: Recruiting
• Phase: Phase 3
• First received: April 24, 2007
• Last updated: April 24, 2007
• Start date: October 2002

Study information

• Verified date: April 2007
• Source: University of Turin, Italy
• Contact: V. M. Ranieri, MD
• Phone: 00390116334001
• Email: marco.ranieri[@]unito.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Procedure:
• Change ventilatory parameters with stress index monitoring

Locations

Country	Name	City	State
Italy	University of Turin, Department of Anesthesia and Intensive Care Medicine	Turin

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction of pulmonary inflammatory mediators