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

U

University of Turin

Status and phase

Unknown
Phase 3

Conditions

Respiratory Distress Syndrome, Adult

Treatments

Procedure: Change ventilatory parameters with stress index monitoring

Study type

Interventional

Funder types

Other

Identifiers

NCT00465374
PRN60ANRA04

Details and patient eligibility

About

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.

Full description

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

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Central trial contact

V. M. Ranieri, MD; P. Terragni, MD

Data sourced from clinicaltrials.gov

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