Assessment of an Oral Endotracheal Subglottic Tube Holder

Intubation Clinical Trial

Official title:

Assessment of AnchorFast Guard Subglottic ET (Endotracheal) Tube

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03328182
• Other study ID #: 5855-I
• Status: Completed
• Phase: N/A
• Start date: October 23, 2017
• Est. completion date: June 15, 2018

Study information

• Verified date: April 2019
• Source: Hollister Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to assess the acceptability and usability of a new Endotracheal Tube (ET) holding device for an orally intubated patient.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Intubation

Intervention

Device:
• New oral endotracheal tube holder
The single arm study product is designed to hold a standard or subglottic ET tube.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Hollister Incorporated

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

Outcome

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)