Assessment of an Oral Endotracheal Subglottic Tube Holder
Completed · Not applicable
Conditions studied: Intubation
In brief
This study is designed to assess the acceptability and usability of a new Endotracheal Tube (ET) holding device for an orally intubated patient.
Key facts
- Study ID
- NCT03328182
- Run by
- Hollister Incorporated
- People needed
- 34
- Starts
- 2017-10-23
- Expected to finish
- 2018-06-15
- Last updated by the study team
- 2019-07-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Is 18 years of age or older and require oral tracheal intubation with subglottic ET tube size 6.0-8.0mm
- Requires the use of a bite block per the hospital's standard of care
- Has intact skin on and around application site, including cheeks and lips
- Oral cavity is free of open sores, ulcers, wounds, and lesions
- Subject or Legal Authorized representative (LAR) able to provide informed consent for the study
- Is qualified to participate in the opinion of the Investigator, or designee
You may not qualify if…
- Has actual or perceived loose teeth, is without teeth, or is unable to wear upper dentures
- Has facial hair that interferes with the adhesion of the skin barrier pads
- 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
- Has a medical condition, surgery or a procedure that prevents the proper application of the device, including placement of the neck strap.
- Has a known or stated allergy to adhesives
- Currently is participating in any clinical study which may affect the performance of the device
Where it is running
- Community Regional Medical Center — Fresno, California, United States
- Legacy Mount Hood Medical Center — Gresham, Oregon, United States
- Legacy Good Samaritan Medical Center — Portland, Oregon, United States
- Legacy Emanuel Hospital & Health Center — Portland, Oregon, United States
Full record on ClinicalTrials.gov
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