Assessment of an Endotracheal Tube Securement Device

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Hollister Incorporated
Sponsor:
Information provided by (Responsible Party):
Hollister Incorporated
ClinicalTrials.gov Identifier:
NCT01651260
First received: July 16, 2012
Last updated: February 12, 2013
Last verified: February 2013
  Purpose

Endotracheal intubation is the translaryngeal placement of a tube into the trachea via the nose or mouth. Endotracheal tubes must be securely fixed to prevent movement, which may result in accidental slippage of the tube into a mainstream bronchus or into the pharynx. Hollister Incorporated is assessing the functionality and performance of an endotracheal tube securement device.


Condition Intervention
Endotracheal Intubation
Endotracheal Tube
Device: Hollister endotracheal tube securement device

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Assessment of the Functionality and Performance of an ET Tube Protection Device

Further study details as provided by Hollister Incorporated:

Primary Outcome Measures:
  • Assess devices ability to protect the endotracheal tube [ Time Frame: Between 1-14 days ] [ Designated as safety issue: Yes ]
    Number of participants who experienced damage to the endotracheal tube. Number of participants who experienced occlusion of endotracheal tube.


Secondary Outcome Measures:
  • Assess acceptability of use through clinician assessment of device characteristics [ Time Frame: Between 1 - 14 days ] [ Designated as safety issue: No ]
    Ease of application, removal, and maintaining, and overall acceptability to clinicians using a Likert scale


Estimated Enrollment: 68
Study Start Date: July 2012
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hollister ET tube securement device Device: Hollister endotracheal tube securement device
Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Is 18 years of age or older; male or female and requiring oral tracheal intubation.
  • Has intact skin on application site.
  • Willingly signs or their authorized representative willingly signs the Informed Consent.
  • Is qualified to participate in the opinion of the Investigator.

Exclusion Criteria:

  • Has an existing neck injury.
  • Has protruding upper teeth, without teeth or is unable to wear upper dentures.
  • Has facial hair.
  • Has clinically significant skin diseases on the application site which may contraindicate participation, including psoriasis, eczema, atopic dermatitis, active cancer.
  • Has damaged skin or conditions on the application site which includes sunburn, scars, moles or other disfiguration of the test site.
  • Has a known or stated allergy to adhesive bandages, or any of the product types being tested.
  • Uses of topical drugs on the application site.
  • Uses lotions, creams or oils on the application site.
  • Currently is participating in any clinical testing which may affect performance of this device.
  • Has been previously intubated with skin irritation or pressure sores surrounding the mouth.
  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: NCT01651260

Contacts
Contact: Elizabeth Konz, PhD 847-918-7680 Elizabeth.Konz@Hollister.com

Locations
United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States
Contact: Devin Chambers, RT         
United States, District of Columbia
Medstar Washington Hospital Center Active, not recruiting
Washington, District of Columbia, United States
United States, Florida
St. Joseph's Hospitals Recruiting
Tampa, Florida, United States
Contact: Daniel C. Ayers, RRT-NPS         
United States, Oregon
Legacy Good Samaritan Recruiting
Portland, Oregon, United States
Contact: Brian Young, MD         
United States, Washington
Legacy Salmon Creek Medical Center Recruiting
Vancouver, Washington, United States, 98686
Contact: Todd W Gienapp, DO    360-253-3293    TGienapp@tvc.org   
Contact: Michelle Russell-Payne, RRT, MBA    360-487-3260    mrussell@lhs.org   
Sponsors and Collaborators
Hollister Incorporated
Investigators
Study Chair: Elizabeth Konz, PhD Hollister Incorporated
  More Information

No publications provided

Responsible Party: Hollister Incorporated
ClinicalTrials.gov Identifier: NCT01651260     History of Changes
Other Study ID Numbers: 5156-I
Study First Received: July 16, 2012
Last Updated: February 12, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 22, 2014