Expired Study
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Nashville, Tennessee 37212


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - ARDS - post-surgical - ventilator Exclusion Criteria: - rib fracture - pneumonia - sepsis


Study is Available At:


Original ID:

CHughes-PGY2


NCT ID:

NCT00656071


Secondary ID:


Study Acronym:


Brief Title:

Retrospective Postoperative ARDS Study at Vanderbilt University


Official Title:

Intraoperative Anesthetic Characteristics and the Development of ARDS


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

11 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Vanderbilt University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case Control, Time Perspecti


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

89


Enrollment Type:

Actual


Overall Contact Information

Official Name:Christopher G Hughes, M.D.
Principal Investigator
Vanderbilt University

Study Dates

Start Date:October 2007
Completion Date:August 2008
Completion Type:Actual
Primary Completion Date:August 2008
Primary Completion Type:Actual
Verification Date:September 2012
Last Changed Date:September 5, 2012
First Received Date:April 4, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:ARDS
Time Frame:data pulled from 10/2000 - 08/2007
Safety Issues:True

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:2
Description:Cases -- postoperative mechanical ventilation patients with ARDS
Study Arm Type:Other
Arm Name:1
Description:Control -- postoperative mechanical ventilation patients without ARDS

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Vanderbilt University

Samples and Retentions

Study Population: The surgical and post-op patients at VUMC. The collection dates will be from October 1, 2001 until August 31, 2007.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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