Assessment of an Endotracheal Tube Securement Device

Endotracheal Intubation Clinical Trial

Official title:

Assessment of the Functionality and Performance of an ET Tube Protection Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01651260
• Other study ID #: 5156-I
• Status: Completed
• Phase: N/A
• First received: July 16, 2012
• Last updated: September 22, 2015
• Start date: July 2012
• Est. completion date: February 2013

Study information

• Verified date: September 2015
• Source: Hollister Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Endotracheal Intubation
• Endotracheal Tube

Intervention

Device:
• Hollister endotracheal tube securement device
Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject.

Locations

Country	Name	City	State
United States	Hartford Hospital	Hartford	Connecticut
United States	Legacy Good Samaritan	Portland	Oregon
United States	St. Joseph's Hospitals	Tampa	Florida
United States	Legacy Salmon Creek Medical Center	Vancouver	Washington
United States	Medstar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Hollister Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevention of Damage and/or Occlusion of ET Tube During Use	Number of participants with damage of ET tube and Number of participants with occlusion of ET tube	14 days	Yes
Secondary	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	No