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

Tracking Information

• First Submitted Date: July 16, 2012
• First Posted Date: July 27, 2012
• Results First Submitted Date: March 18, 2014
• Results First Posted Date: October 28, 2015
• Last Update Posted Date: March 23, 2016
• Study Start Date: July 2012
• Actual Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 23, 2016)

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

Original Primary Outcome Measures (submitted: July 24, 2012)

Assess devices ability to protect the endotracheal tube [ Time Frame: Between 1-14 days ]

Number of participants who experienced damage to the endotracheal tube. Number of participants who experienced occlusion of endotracheal tube.

Current Secondary Outcome Measures (submitted: September 22, 2015)

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);

Original Secondary Outcome Measures (submitted: July 24, 2012)

Assess acceptability of use through clinician assessment of device characteristics [ Time Frame: Between 1 - 14 days ]

Ease of application, removal, and maintaining, and overall acceptability to clinicians using a Likert scale

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Assessment of an Endotracheal Tube Securement Device
• Official Title: Assessment of the Functionality and Performance of an Endotracheal (ET) Tube Protection Device
• 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.
• 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
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Respiratory Insufficiency

Intervention

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

Study Arms

Endotracheal (ET) tube securement device

Single arm study evaluated an experimental ET tube securement device with a bite block.

Intervention: Other: Experimental ET Tube Securement Device

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 22, 2015): 65
• Original Estimated Enrollment (submitted: July 24, 2012): 68
• Actual Study Completion Date: February 2013
• Actual Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01651260
• Other Study ID Numbers: 5156-I
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Hollister Incorporated
• Study Sponsor: Hollister Incorporated
• Collaborators: Not Provided

Investigators

• Study Chair: Elizabeth Konz, PhD; Hollister Incorporated

• PRS Account: Hollister Incorporated
• Verification Date: February 2016