A Validation/Interventional Study on Stress Index in Pred... | NCT00465374

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

NCT00465374

Sponsor

University of Turin, Italy

Status

Unknown status

Last Update Posted

Apr 25, 2007Estimated

Enrollment

Not provided

Phase

Phase 3

Conditions

Respiratory Distress Syndrome, Adult

Interventions

Change ventilatory parameters with stress index monitoring

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2002

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Apr 24, 2007

First Submission Date that Met QC Criteria

Apr 24, 2007

First Posted Date

Apr 25, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2007

Last Update Posted Date

Apr 25, 2007Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Change ventilatory parameters with stress index monitoring	Procedure

Measure	Description	Time Frame
reduction of pulmonary inflammatory mediators

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
V. M. Ranieri, MD	Contact	00390116334001		marco.ranieri@unito.it
P. Terragni, MD	Contact	00390116334002		pierpaolo.terragni@unito.it

Overall Officials

Name	Affiliation	Role
V. M. Ranieri, MD	University of Turin, Italy	Study Director
P. Terragni, MD	University of Turin, Italy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Turin, Department of Anesthesia and Intensive Care Medicine	Recruiting	Turin			Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11046222	Background	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.
15071395	Background

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders