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

NCT ID: NCT00465374

Last Updated: 2007-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Brief Summary

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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

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

Conditions

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Respiratory Distress Syndrome, Adult

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Change ventilatory parameters with stress index monitoring

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Turin, Italy

OTHER

Sponsor Role lead

Principal Investigators

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V. M. Ranieri, MD

Role: STUDY_DIRECTOR

University of Turin, Italy

P. Terragni, MD

Role: PRINCIPAL_INVESTIGATOR

University of Turin, Italy

Locations

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University of Turin, Department of Anesthesia and Intensive Care Medicine

Turin, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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V. M. Ranieri, MD

Role: CONTACT

[email protected]
00390116334001

P. Terragni, MD

Role: CONTACT

[email protected]
00390116334002

Facility Contacts

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V. M. Ranieri, MD

Role: primary

[email protected]
+390116334001

P. Terragni, MD

Role: backup

[email protected]
+390116334002

References

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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.

Reference Type BACKGROUND
PMID: 11046222 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15071395 (View on PubMed)

Other Identifiers

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PRN60ANRA04

Identifier Type: -

Identifier Source: org_study_id