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

University of Turin, Italy

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Respiratory Distress Syndrome, Adult

Interventions

Change ventilatory parameters with stress index monitoringPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Turin, Department of Anesthesia and Intensive Care Medicine

Turin, Italy

RECRUITING

Outcomes

Primary Outcomes

reduction of pulmonary inflammatory mediators

Central Contacts

V. M. Ranieri, MD

CONTACT

00390116334001 marco.ranieri@unito.it

P. Terragni, MD

CONTACT

00390116334002 pierpaolo.terragni@unito.it

Data from ClinicalTrials.gov

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