Skip to content

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00465374
Enrollment
Unknown
Registered
2007-04-25
Start date
2002-10-31
Completion date
Unknown
Last updated
2007-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome, Adult

Keywords

ARDS, Pressure/time curve, Stress Index

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.

Detailed description

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

Interventions

PROCEDUREChange ventilatory parameters with stress index monitoring

Sponsors

University of Turin, Italy
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
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

Design outcomes

Primary

MeasureTime frame
reduction of pulmonary inflammatory mediators

Countries

Italy

Contacts

Primary ContactV. M. Ranieri, MD
marco.ranieri@unito.it00390116334001
Backup ContactP. Terragni, MD
pierpaolo.terragni@unito.it00390116334002

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026