Assessment of an Endotracheal Tube Securement Device

• ClinicalTrials.gov Identifier: NCT01651260
• Recruitment Status: Completed
• First Posted: July 27, 2012
• Results First Posted: October 28, 2015
• Last Update Posted: March 23, 2016
• Sponsor: Hollister Incorporated
• Information provided by (Responsible Party): Hollister Incorporated

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Respiratory Insufficiency	Other: Experimental ET Tube Securement Device	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 65 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Assessment of the Functionality and Performance of an Endotracheal (ET) Tube Protection Device
• Study Start Date: July 2012
• Actual Primary Completion Date: February 2013
• Actual Study Completion Date: February 2013

Arms and Interventions

Arm	Intervention/treatment
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 Name: AnchorFast Guard® ET tube securement device

Outcome Measures

Primary Outcome Measures :

1. Prevention of Damage and/or Occlusion of Endotracheal (ET) Tube During Use [ Time Frame: 14 days ]
   Number of participants with damage of ET tube and Number of participants with occlusion of ET tube

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, Connecticut

Hartford Hospital

Hartford, Connecticut, United States, 06102

United States, District of Columbia

Medstar Washington Hospital Center

Washington, District of Columbia, United States, 20010

United States, Florida

St. Joseph's Hospitals

Tampa, Florida, United States, 33607

United States, Oregon

Legacy Good Samaritan

Portland, Oregon, United States, 97210

United States, Washington

Legacy Salmon Creek Medical Center

Vancouver, Washington, United States, 98686

Sponsors and Collaborators

Hollister Incorporated

Investigators

• Study Chair: Elizabeth Konz, PhD; Hollister Incorporated

More Information

• Responsible Party: Hollister Incorporated
• ClinicalTrials.gov Identifier: NCT01651260
• Other Study ID Numbers: 5156-I
• First Posted: July 27, 2012
• Results First Posted: October 28, 2015
• Last Update Posted: March 23, 2016
• Last Verified: February 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Respiratory Insufficiency; Pulmonary Valve Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases