N/A
N=34
Assessment of an Oral Endotracheal Subglottic Tube Holder
Intubation
Bottom Line
View on ClinicalTrials.gov: NCT03328182 ↗Enrolled (actual)
34
Serious AEs
10.0%
Results posted
Jul 2019
Primary outcome: Primary: Overall Acceptability With Study Product — 13; 15; 0; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- New oral endotracheal tube holder (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hollister Incorporated
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Acceptability With Study Product |
13; 15; 0; 2; 0 | — |
| PRIMARY Usability of Study Product |
20; 8; 1; 1; 0; 0 | — |
Summary
This study is designed to assess the acceptability and usability of a new Endotracheal Tube (ET) holding device for an orally intubated patient.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03328182). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.