Study the Average Aerobic Bioburden Levels on Catheters After Use With Egret Catheter and the Predicate Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01124578
Recruitment Status : Completed
First Posted : May 17, 2010
Last Update Posted : May 17, 2010
Information provided by:
Egret Medical Products Inc.

Brief Summary:
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.

Condition or disease
Suction Catheter Bioburder Level After Patient Use.

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 200 participants
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
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. No unexpected adverse events [ Time Frame: 1-10 days ]
    Verify that there were no unexpected adverse events associated with the Egret extended use catheter.

  2. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients admitted to Medical City who require ventilation

Inclusion Criteria:

  • Patients who agree to consent.

Exclusion Criteria:

  • Patients who do not agree to consent or with confirmed Ventilator-associated Pneumonia (VAP)are to be excluded from this study.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01124578

United States, Texas
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Sponsors and Collaborators
Egret Medical Products Inc.
Principal Investigator: David Barton, BA, RRT, RCP Medical City Hospital, Dallas, TX

1.Medical City Dallas Hospital, Policies and Procedures, Policy No. RSCC12 - Endotracheal Suctioning 2.MicroChem Labs - A Study to Measure the Total Aerobic Bacteria on Ballard Suction Catheters During 24 Hours Use with Respiratory Care Patients. This study was conducted to establish a baseline bio-burden count of catheter tips after use. 3.Nelson Laboratories - Bacterial Filtration Efficacy, Report No. 413451. This test was preformed to determine the bacterial filtration efficacy of the filter as per ASTM F2101. 4.Micro-Chem Labs - Evaluation of the Antimicrobial Properties of Sterilized and Non-Sterilized Egret Catheters Versus a Non-Treated Control Catheter During Extended Exposure to S. aureus, P. aeruginosa, and K. pneumoniae.

Responsible Party: David Barton, BA, RRT, RCP, Medical City Dallas Hospital Identifier: NCT01124578     History of Changes
Other Study ID Numbers: RT 2008-001
First Posted: May 17, 2010    Key Record Dates
Last Update Posted: May 17, 2010
Last Verified: May 2010

Keywords provided by Egret Medical Products Inc.:
Ventilators, Mechanical