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Endotracheal Tube Fastener

Trial

Clinical Trial Title

Endotracheal Tube Fastener

Trial Status

Open to Enrollment

Start Date

October 23, 2017

Trial Type

Emergency Medicine

Specific Condition

Patients that require oral tracheal intubation

Description

This study is designed to assess the acceptability and usability of a new Endotracheal Tube (ET) holding device for an orally intubated patient.

This is a multiple site prospective assessment of the study product in ICU settings. The study is comprised of each intubated subject wearing one study product until the device either needs to be changed or is no longer required by the subject. The study product is designed to hold a standard or subglottic ET tube and help reduce the potential for occlusion (blockage) of the tube.

Eligibility Criteria

Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria

INCLUSION CRITERIA

  1. Is 18 years of age or older and require oral tracheal intubation with subglottic ET tube size 6.0-8.0mm
  2. Requires the use of a bite block per the hospital's standard of care
  3. Has intact skin on and around application site, including cheeks and lips
  4. Oral cavity is free of open sores, ulcers, wounds, and lesions
  5. Subject or Legal Authorized representative (LAR) able to provide informed consent for the study
  6. Is qualified to participate in the opinion of the Investigator, or designee

EXCLUSION CRITERIA

  1. Has actual or perceived loose teeth, is without teeth, or is unable to wear upper dentures
  2. Has facial hair that interferes with the adhesion of the skin barrier pads
  3. Has a clinically significant skin disease or condition, or damaged skin on the application site, such as psoriasis, eczema, atopic dermatitis, active cancer, sores, sunburns, scars, moles
  4. Has a medical condition, surgery or a procedure that prevents the proper application of the device, including placement of the neck strap.
  5. Has a known or stated allergy to adhesives
  6. Currently is participating in any clinical study which may affect the performance of the device

IRB Number

10807

Principal Investigator Name

Brian Young, MD

Contact Name

Karla Kummer

Phone

503-692-8419

Contact Fax

503-413-3543

Contact E-Mail

kkummer@lhs.org

Last Updated: Friday, November 3, 2017 04:01:35 PM