Assessment of an Oral Endotracheal Subglottic Tube Holder

Assessment of AnchorFast Guard Subglottic ET (Endotracheal) Tube

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

Study Overview

• Status: Completed
• Conditions: Intubation
• Intervention / Treatment: Device: New oral endotracheal tube holder

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Fresno, California, United States, 93701
      • Community Regional Medical Center
  • Oregon
    • Gresham, Oregon, United States, 97030
      • Legacy Mount Hood Medical Center
    • Portland, Oregon, United States, 97210
      • Legacy Good Samaritan Medical Center
    • Portland, Oregon, United States, 97227
      • Legacy Emanuel Hospital & Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: New oral endotracheal tube holder; Single Study Product Arm	Device: New oral endotracheal tube holder; The single arm study product is designed to hold a standard or subglottic ET tube.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: Hollister Incorporated
• Investigators: Principal Investigator: Laura Vander Werff, MD, Legacy Mount Hood Medical Center; Principal Investigator: Brian Young, MD, 1. Legacy Emanuel Hospital & Health Center 2. Legacy Good Samaritan Medical Center; Principal Investigator: Arash Afshinnik, MD, Community Regional Medical Center

Publications and helpful links

General Publications

• 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.
• 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

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2017
• Primary Completion (Actual): June 8, 2018
• Study Completion (Actual): June 15, 2018

Study Registration Dates

• First Submitted: October 16, 2017
• First Submitted That Met QC Criteria: October 27, 2017
• First Posted (Actual): November 1, 2017

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 2, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 5855-I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No