Assessment of an Endotracheal Tube Securement Device

Assessment of the Functionality and Performance of an Endotracheal (ET) Tube Protection Device

Endotracheal intubation is the translaryngeal placement of a tube into the trachea via the nose or mouth. Endotracheal tubes must be securely fixed to prevent movement, which may result in accidental slippage of the tube into a mainstream bronchus or into the pharynx. Hollister Incorporated is assessing the functionality and performance of an endotracheal tube securement device.

Study Overview

• Status: Completed
• Conditions: Respiratory Insufficiency
• Intervention / Treatment: Other: Experimental ET Tube Securement Device

Detailed Description

This was a multiple site assessment of the Anchor Fast with enhanced tube protection. Subjects already intubated who required a change of tube-securing device or subjects requiring intubation for greater than 24 hours who meet the inclusion and exclusion criteria were eligible to enroll into the study.The study was open to adult subjects without an existing neck injury who required oral tracheal intubation for greater than 24 hours. Subjects were required to have intact skin on the application site and to be free of facial hair, damaged skin or conditions on the application site (e.g. sunburn, scars, moles or other disfigurations), and significant skin diseases on the application site (e.g. psoriasis, eczema, atopic dermatitis, active cancer) which may have contraindicated participation.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Medstar Washington Hospital Center
  • Florida
    • Tampa, Florida, United States, 33607
      • St. Joseph's Hospitals
  • Oregon
    • Portland, Oregon, United States, 97210
      • Legacy Good Samaritan
  • Washington
    • Vancouver, Washington, United States, 98686
      • Legacy Salmon Creek Medical 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:

• Is 18 years of age or older; male or female and requiring oral tracheal intubation.
• Has intact skin on application site.
• Willingly signs or their authorized representative willingly signs the Informed Consent.
• Is qualified to participate in the opinion of the Investigator.

Exclusion Criteria:

• Has an existing neck injury.
• Has protruding upper teeth, without teeth or is unable to wear upper dentures.
• Has facial hair.
• Has clinically significant skin diseases on the application site which may contraindicate participation, including psoriasis, eczema, atopic dermatitis, active cancer.
• Has damaged skin or conditions on the application site which includes sunburn, scars, moles or other disfiguration of the test site.
• Has a known or stated allergy to adhesive bandages, or any of the product types being tested.
• Uses of topical drugs on the application site.
• Uses lotions, creams or oils on the application site.
• Currently is participating in any clinical testing which may affect performance of this device.
• Has been previously intubated with skin irritation or pressure sores surrounding the mouth.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Endotracheal (ET) tube securement device; Single arm study evaluated an experimental ET tube securement device with a bite block.	Other: Experimental ET Tube Securement Device; Experimental Hollister device with bite block was substituted for standard-of-care device during the study period.; Other Names: AnchorFast Guard® ET tube securement device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevention of Damage and/or Occlusion of Endotracheal (ET) Tube During Use	Number of participants with damage of ET tube and Number of participants with occlusion of ET tube	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of Use	Likert scale score provided by clinician (1 very difficult, 2 difficult, 3 neither easy nor difficult, 4 easy, 5 very easy);	Between 1 - 14 days

Collaborators and Investigators

• Sponsor: Hollister Incorporated
• Investigators: Study Chair: Elizabeth Konz, PhD, Hollister Incorporated

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: July 16, 2012
• First Submitted That Met QC Criteria: July 24, 2012
• First Posted (Estimate): July 27, 2012

Study Record Updates

• Last Update Posted (Estimate): March 23, 2016
• Last Update Submitted That Met QC Criteria: February 23, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 5156-I

Plan for Individual participant data (IPD)

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