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

Primary Purpose

Respiratory Distress Syndrome, Adult

Status

Unknown status

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

Change ventilatory parameters with stress index monitoring

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome, Adult focused on measuring ARDS, Pressure/time curve, Stress Index

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of Turin, Department of Anesthesia and Intensive Care MedicineRecruiting

Outcomes

Primary Outcome Measures

reduction of pulmonary inflammatory mediators

Secondary Outcome Measures

Full Information

NCT ID

NCT00465374

First Posted

April 24, 2007

Last Updated

April 24, 2007

Sponsor

University of Turin, Italy

1. Study Identification

Unique Protocol Identification Number

NCT00465374

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2007

Overall Recruitment Status

Unknown status

Study Start Date

October 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of Turin, Italy

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Distress Syndrome, Adult

Keywords

ARDS, Pressure/time curve, Stress Index

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Change ventilatory parameters with stress index monitoring

Primary Outcome Measure Information:

Title

reduction of pulmonary inflammatory mediators

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

V. M. Ranieri, MD

Phone

00390116334001

marco.ranieri@unito.it

First Name & Middle Initial & Last Name or Official Title & Degree

P. Terragni, MD

Phone

00390116334002

pierpaolo.terragni@unito.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

V. M. Ranieri, MD

Organizational Affiliation

University of Turin, Italy

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

P. Terragni, MD

Organizational Affiliation

University of Turin, Italy

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Turin, Department of Anesthesia and Intensive Care Medicine

City

Turin

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

V. M. Ranieri, MD

Phone

+390116334001

marco.ranieri@unito.it

First Name & Middle Initial & Last Name & Degree

P. Terragni, MD

Phone

+390116334002

pierpaolo.terragni@unito.it

12. IPD Sharing Statement

Citations:

PubMed Identifier

11046222

Citation

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.

Results Reference

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PubMed Identifier

15071395

Citation

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.

Results Reference

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

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