Status:
COMPLETED
Assessment of an Oral Endotracheal Subglottic Tube Holder
Lead Sponsor:
Hollister Incorporated
Conditions:
Intubation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is designed to assess the acceptability and usability of a new Endotracheal Tube (ET) holding device for an orally intubated patient.
Detailed Description
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 chan...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- 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
- EXCLUSION CRITERIA
- 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
Exclusion
Key Trial Info
Start Date :
October 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2018
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03328182
Start Date
October 23 2017
End Date
June 15 2018
Last Update
July 5 2019
Active Locations (4)
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1
Community Regional Medical Center
Fresno, California, United States, 93701
2
Legacy Mount Hood Medical Center
Gresham, Oregon, United States, 97030
3
Legacy Good Samaritan Medical Center
Portland, Oregon, United States, 97210
4
Legacy Emanuel Hospital & Health Center
Portland, Oregon, United States, 97227