Retrospective ARDS Study at Vanderbilt University - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

April 4, 2008

Last Updated Date

April 4, 2008

Start Date ^†

October 2007

Current Primary Outcome Measures ^†

ARDS [ Time Frame: data pulled from 10/2000 - 08/2007 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^†

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Retrospective ARDS Study at Vanderbilt University

Official Title ^†

Intraoperative Anesthetic Characteristics and the Development of ARDS

Brief Summary

By examining the intraoperative anesthetic characteristics of patients who developed ARDS postoperatively, we hope to identify variables which have a positive or negative association on the development of ARDS.

Detailed Description

Acute respiratory distress syndrome (ARDS) is a pulmonary disease process that affects post-surgical patients in the intensive care unit and leads to significant patient morbidity and mortality and hospital cost. Extensive research has been conducted in the diagnosis and treatment of ARDS. To date, however, very little research examining the effect of the operative course on the development of ARDS has been reported. By examining the intraoperative anesthetic characteristics of patients who developed ARDS postoperatively, we hope to identify variables which have a positive or negative association on the development of ARDS. Once identified, the variables can be confirmed by future studies and encourage change in clinical care to decrease the occurrence of ARDS in surgical patients.

Study Phase

Study Type ^†

Observational

Study Design ^†

Case Control, Retrospective

Condition ^†

ARDS

Intervention ^†

Study Arms / Comparison Groups

Control
ARDS Patients

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Estimated Enrollment ^†

300

Estimated Completion Date

November 2008

Estimated Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

ARDS
post-surgical
ventilator

Exclusion Criteria:

rib fracture
pneumonia
sepsis

Gender

Both

Ages

11 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00656071

Responsible Party

Christopher G. Hughes, Vanderbilt University Medical Center

Secondary IDs ^††

Study Sponsor ^†

Vanderbilt University

Collaborators ^††

Investigators ^†

Principal Investigator:

Christopher G Hughes, M.D.

Vanderbilt University

Information Provided By

Vanderbilt University

Verification Date

April 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.