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Completed

NCT Number: NCT03328182

Assessment of an Oral Endotracheal Subglottic Tube Holder

This study is designed to assess the acceptability and usability of a new Endotracheal Tube (ET) holding device for an orally intubated patient.

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Key information

Conditions

Intubation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Community Regional Medical Center, Fresno, California, United States

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About this study

This is a multiple site prospective assessment of the study product in ICU settings. The study is comprised of each intubated subject wearing one study product until the device either needs to be changed or is no longer required by the subject. The study product is designed to hold a standard or subglottic ET tube and help reduce the potential for occlusion (blockage) of the tube.

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 and require oral tracheal intubation with subglottic ET tube size 6.0-8.0mm
  • Requires the use of a bite block per the hospital's standard of care
  • Has intact skin on and around application site, including cheeks and lips
  • Oral cavity is free of open sores, ulcers, wounds, and lesions
  • Subject or Legal Authorized representative (LAR) able to provide informed consent for the study
  • Is qualified to participate in the opinion of the Investigator, or designee

Exclusion criteria

  • Has actual or perceived loose teeth, is without teeth, or is unable to wear upper dentures
  • Has facial hair that interferes with the adhesion of the skin barrier pads
  • Has a clinically significant skin disease or condition, or damaged skin on the application site, such as psoriasis, eczema, atopic dermatitis, active cancer, sores, sunburns, scars, moles
  • Has a medical condition, surgery or a procedure that prevents the proper application of the device, including placement of the neck strap.
  • Has a known or stated allergy to adhesives
  • Currently is participating in any clinical study which may affect the performance of the device

Treatment and study plan

New oral endotracheal tube holder

Device

The single arm study product is designed to hold a standard or subglottic ET tube.

Primary outcomes

  1. Overall Acceptability With Study Product

    Time frame: At product removal (maximum 29 days of patient wearing product)

    The overall acceptability relating to general experience with the study product during use will be rated with a 5-point Likert scale ranging from 1=Very Unacceptable to 5=Very Acceptable

  2. Usability of Study Product

    Time frame: At application and product removal (maximum 29 days of patient wearing product)

    The usability of the study product at application and at removal.

Sponsors and collaborators

Lead sponsor

Hollister Incorporated

Industry

Registry information

Official study title

Assessment of AnchorFast Guard Subglottic ET (Endotracheal) Tube

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 1, 2017
Registry last updated
Jul 5, 2019

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.

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