Clinical trial NCT03328182: Assessment of an Oral Endotracheal Subglottic Tube Holder
Official title: Assessment of AnchorFast Guard Subglottic ET (Endotracheal) Tube
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation
Lead sponsor: Hollister Incorporated
Sponsor class: INDUSTRY
First posted: 2017-11-01
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 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: 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

Primary outcomes:
measure: Overall Acceptability With Study Product
timeFrame: At product removal (maximum 29 days of patient wearing product)
measure: Usability of Study Product
timeFrame: At application and product removal (maximum 29 days of patient wearing product)
Secondary outcomes:
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Community Regional Medical Center
state: California
city: Gresham
country: United States
facility: Legacy Mount Hood Medical Center
state: Oregon
city: Portland
country: United States
facility: Legacy Good Samaritan Medical Center
state: Oregon
city: Portland
country: United States
facility: Legacy Emanuel Hospital & Health Center
state: Oregon
Study officials:
affiliation: Legacy Mount Hood Medical Center
name: Laura Vander Werff, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 1. Legacy Emanuel Hospital & Health Center 2. Legacy Good Samaritan Medical Center
name: Brian Young, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Community Regional Medical Center
name: Arash Afshinnik, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buckley JC, Brown AP, Shin JS, Rogers KM, Hoftman NN. A Comparison of the Haider Tube-Guard(R) 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.
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