Study the Average Aerobic Bioburden Levels on Catheters After Use With Egret Catheter and the Predicate Device
PURPOSE OF EVALUATION: This study will verify & validate the acceptability of Egret's extended use product as compared to the existing daily change-out product. Based on an extensive in-vitro study, Egret's product confirmed significant kill for both positive and negative gram bacteria. In addition to meeting all of the current product requirements, total aerobic bio-burden on the catheters will be tested at various intervals for up to 10 days of use. The current used product will be used as a control group that is to be changed out daily as per current policy. The control group will be tested for total aerobic bacteria counts on the last day of use.
Suction Catheter Bioburder Level After Patient Use.
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||Validate the Acceptability of Egret's Extended Use Product as Compared to the Existing Daily Change-out Product|
- Measure total aerobic bioburden levels after patient use [ Time Frame: 1 to 10 days ] [ Designated as safety issue: No ]Compare the average aerobic bio-burden level on the extended use Egret catheter to the existing used one day product after clinical use. The Egret catheter was used continuously for up to 10 days.
- No unexpected adverse events [ Time Frame: 1-10 days ] [ Designated as safety issue: Yes ]Verify that there were no unexpected adverse events associated with the Egret extended use catheter.
- Design Ease of Use [ Time Frame: 1-10 days ] [ Designated as safety issue: No ]Obtain feedback from the respiratory care practitioners regarding comparative ease-of-use and design feature preferences between the Egret catheter and the Ballard catheter.
|Study Start Date:||May 2008|
|Study Completion Date:||March 2010|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Existing used daily change-out device
Extended Use Catheter w/BIOSAFE
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01124578
|United States, Texas|
|Medical City Dallas Hospital|
|Dallas, Texas, United States, 75230|
|Principal Investigator:||David Barton, BA, RRT, RCP||Medical City Hospital, Dallas, TX|