Study the Average Aerobic Bioburden Levels on Catheters After Use With Egret Catheter and the Predicate Device
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|ClinicalTrials.gov Identifier: NCT01124578|
Recruitment Status : Completed
First Posted : May 17, 2010
Last Update Posted : May 17, 2010
|Condition or disease|
|Suction Catheter Bioburder Level After Patient Use.|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||200 participants|
|Observational Model:||Case Control|
|Official Title:||Validate the Acceptability of Egret's Extended Use Product as Compared to the Existing Daily Change-out Product|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||March 2010|
Existing used daily change-out device
Extended Use Catheter w/BIOSAFE
- Measure total aerobic bioburden levels after patient use [ Time Frame: 1 to 10 days ]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 ]Verify that there were no unexpected adverse events associated with the Egret extended use catheter.
- Design Ease of Use [ Time Frame: 1-10 days ]Obtain feedback from the respiratory care practitioners regarding comparative ease-of-use and design feature preferences between the Egret catheter and the Ballard catheter.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|