Retrospective Postoperative ARDS Study at Vanderbilt Univ... | NCT00656071

Studies
Retrospective Postoperative ARDS Study at Vanderbilt University

NCT00656071

Sponsor

Vanderbilt University

Status

Completed

Last Update Posted

Sep 7, 2012Estimated

Enrollment

89Actual

Phase

Not provided

Conditions

ARDS

Interventions

Not provided

Countries

United States

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

Sep 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Aug 2008Actual

Completion Date

Aug 2008Actual

First Submitted Date

Apr 4, 2008

First Submission Date that Met QC Criteria

Apr 4, 2008

First Posted Date

Apr 10, 2008Estimated

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

Sep 5, 2012

Last Update Posted Date

Sep 7, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

89Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Control -- postoperative mechanical ventilation patients without ARDS
2		Cases -- postoperative mechanical ventilation patients with ARDS

Interventions

Not provided

Measure	Description	Time Frame
ARDS		data pulled from 10/2000 - 08/2007

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ARDS
post-surgical
ventilator

Exclusion Criteria:

rib fracture
pneumonia
sepsis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

11 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The surgical and post-op patients at VUMC. The collection dates will be from October 1, 2001 until August 31, 2007.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christopher G Hughes, M.D.	Vanderbilt University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt University Medical Center		Nashville	Tennessee	37212	United States

Label	URL
Vanderbilt Department of Anesthesiology	View source

Condition Browse Module

MeSH Terms

ID	Term
D012128	Respiratory Distress Syndrome
D004417	Dyspnea

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders
D012818	Signs and Symptoms, Respiratory

Browse Leaves

Not provided

Browse Branches

Not provided