NCT00465374

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 25, 2007

Completed
Last Updated

April 25, 2007

Status Verified

April 1, 2007

First QC Date

April 24, 2007

Last Update Submit

April 24, 2007

Conditions

Respiratory Distress Syndrome, Adult

Keywords

ARDSPressure/time curveStress Index

Outcome Measures

Primary Outcomes (1)

  • reduction of pulmonary inflammatory mediators

Interventions

Change ventilatory parameters with stress index monitoringPROCEDURE

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Diagnosis of ARDS based on American-European Consensus Conference criteria

You may not qualify if:

  • \>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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Turin, Department of Anesthesia and Intensive Care Medicine

Turin, Italy

RECRUITING

Related Publications (2)

  • 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. doi: 10.1097/00000542-200011000-00027.

    PMID: 11046222BACKGROUND

  • 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. doi: 10.1097/01.ccm.0000120059.94009.ad.

    PMID: 15071395BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • V. M. Ranieri, MD

    University of Turin, Italy

    STUDY DIRECTOR

  • P. Terragni, MD

    University of Turin, Italy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

V. M. Ranieri, MD

CONTACT

00390116334001marco.ranieri@unito.it

P. Terragni, MD

CONTACT

00390116334002pierpaolo.terragni@unito.it

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 24, 2007

First Posted

April 25, 2007

Study Start

October 1, 2002

Last Updated

April 25, 2007

Record last verified: 2007-04

Locations

IT(1)