Skip to main content
OpenTrials
Completed

NCT Number: NCT01651260

Assessment of an Endotracheal Tube Securement Device

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Respiratory Insufficiency Respiration Disorders Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hartford Hospital, Hartford, Connecticut, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Experimental ET Tube Securement Device

Other

Experimental Hollister device with bite block was substituted for standard-of-care device during the study period.

Other names: AnchorFast Guard® ET tube securement device

Primary outcomes

  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 outcomes

  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);

Sponsors and collaborators

Lead sponsor

Hollister Incorporated

Industry

Registry information

Official study title

Assessment of the Functionality and Performance of an Endotracheal (ET) Tube Protection Device

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 27, 2012
Registry last updated
Mar 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.