Assessment of an Endotracheal Tube Securement Device

Completed · Not applicable

Conditions studied: Respiratory Insufficiency

In brief

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.

Key facts

Study ID

NCT01651260

Run by

Hollister Incorporated

People needed

65

Starts

2012-07-01

Expected to finish

2013-02-01

Last updated by the study team

2016-03-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Hartford Hospital — Hartford, Connecticut, United States
• Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States
• St. Joseph's Hospitals — Tampa, Florida, United States
• Legacy Good Samaritan — Portland, Oregon, United States
• Legacy Salmon Creek Medical Center — Vancouver, Washington, United States

Full record on ClinicalTrials.gov

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