Intubation Clinical Trial
Official title:
Assessment of AnchorFast Guard Subglottic ET (Endotracheal) Tube
NCT number | NCT03328182 |
Other study ID # | 5855-I |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 23, 2017 |
Est. completion date | June 15, 2018 |
Verified date | April 2019 |
Source | Hollister Incorporated |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is designed to assess the acceptability and usability of a new Endotracheal Tube (ET) holding device for an orally intubated patient.
Status | Completed |
Enrollment | 34 |
Est. completion date | June 15, 2018 |
Est. primary completion date | June 8, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Community Regional Medical Center | Fresno | California |
United States | Legacy Mount Hood Medical Center | Gresham | Oregon |
United States | Legacy Emanuel Hospital & Health Center | Portland | Oregon |
United States | Legacy Good Samaritan Medical Center | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Hollister Incorporated |
United States,
Buckley JC, Brown AP, Shin JS, Rogers KM, Hoftman NN. A Comparison of the Haider Tube-Guard® Endotracheal Tube Holder Versus Adhesive Tape to Determine if This Novel Device Can Reduce Endotracheal Tube Movement and Prevent Unplanned Extubation. Anesth Analg. 2016 May;122(5):1439-43. doi: 10.1213/ANE.0000000000001222. — View Citation
Mohammed, H & Hassan, M. (2015). Endotracheal tube securements: Effectiveness of three techniques among orally intubated patients. Egyptian Journal of Chest Diseases and Tuberculosis 64:183-196
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Acceptability With Study Product | The overall acceptability relating to general experience with the study product during use will be rated with a 5-point Likert scale ranging from 1=Very Unacceptable to 5=Very Acceptable | At product removal (maximum 29 days of patient wearing product) | |
Primary | Usability of Study Product | The usability of the study product at application and at removal. | At application and product removal (maximum 29 days of patient wearing product) |
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