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

This study has been completed.
Sponsor:
Information provided by:
Egret Medical Products Inc.
ClinicalTrials.gov Identifier:
NCT01124578
First received: May 7, 2010
Last updated: May 14, 2010
Last verified: May 2010
  Purpose

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
Suction Catheter Bioburder Level After Patient Use.

Study Type: Observational
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

Further study details as provided by Egret Medical Products Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 200
Study Start Date: May 2008
Study Completion Date: March 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Control
Existing used daily change-out device
Egret
Extended Use Catheter w/BIOSAFE

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients admitted to Medical City who require ventilation

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01124578

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

No publications provided

Responsible Party: David Barton, BA, RRT, RCP, Medical City Dallas Hospital
ClinicalTrials.gov Identifier: NCT01124578     History of Changes
Other Study ID Numbers: RT 2008-001
Study First Received: May 7, 2010
Last Updated: May 14, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 16, 2014