Clinical trial NCT01651260: Assessment of an Endotracheal Tube Securement Device
Official title: Assessment of the Functionality and Performance of an Endotracheal (ET) Tube Protection Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Insufficiency
Lead sponsor: Hollister Incorporated
Sponsor class: INDUSTRY
First posted: 2012-07-27
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Prevention of Damage and/or Occlusion of Endotracheal (ET) Tube During Use
timeFrame: 14 days
Secondary outcomes:
measure: Ease of Use
timeFrame: Between 1 - 14 days
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Washington
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
city: Tampa
country: United States
facility: St. Joseph's Hospitals
state: Florida
city: Portland
country: United States
facility: Legacy Good Samaritan
state: Oregon
city: Vancouver
country: United States
facility: Legacy Salmon Creek Medical Center
state: Washington
Study officials:
affiliation: Hollister Incorporated
name: Elizabeth Konz, PhD
role: STUDY_CHAIR
References: