Assessment of a Oral Endotracheal Tube Fastener on Patients Intubated With Oral Endotracheal Tubes

August 9, 2018 updated by: Hollister Incorporated

Assessment of AnchorFast Guard Oral Endotracheal Tube Fastener on Patients Intubated With Oral Endotracheal Tubes With Subglottic Suction

Assessment of AnchorFast Guard Oral Endotracheal Tube Fastener on Patients Intubated with Oral Endotracheal Tubes with Subglottic Suction

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Endotracheal intubation is the trans laryngeal placement of a tube into the trachea via the nose or mouth. Subglottic suctioning, during endotracheal tube securement, is important for mechanically-ventilated patients to allow for the clearance of secretions that may accumulate during intubation. This protocol examines an enhancement to the current AnchorFast Guard device in order for the device to hold a subglottic suctioning lumen in addition to the intubation tube.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Gresham, Oregon, United States, 97030
        • Legacy Mt Hood
      • Portland, Oregon, United States, 97210
        • Legacy Good Samaritan
    • Washington
      • Vancouver, Washington, United States, 98686
        • Legacy Salmon Creek Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Is 18 years of age or older and requires oral tracheal intubation
  • Has intact skin on application site
  • Is qualified to participate in the opinion of the Investigator including the requirement for endotracheal tube with subglottic suction

Exclusion Criteria:

  • Has an existing neck injury
  • Has protruding upper teeth, is without teeth or is unable to wear upper dentures
  • Has facial hair
  • Has clinically significant skin damage, condition or disease on the application site which may contraindicate participation
  • Has a known or stated allergy to adhesive bandages, or any of the product types being tested
  • Uses of topical drugs, lotions, creams or oils on the application site
  • Is participating in any clinical testing which may affect performance of this device
  • AnchorFast Guard Oral Endotracheal Tube Fastener does not fit subject's face

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endotracheal Tube Fastener
The intervention administered is a revised commercially available endotracheal tube holder with a tract to accommodate a subglottic suction lumen of an oral endotracheal tube.
Device: Endotracheal Tube Fastener
The AnchorFast Guard oral endotracheal tube fastener provides a convenient means to hold an oral endotracheal tube securely in place without the use of adhesive tape. The oral endotracheal tube fastener allows repositioning of the tube in either direction along the track without removal of the device.
Other Names:
  • AnchorFast Guard Oral Endotracheal Tube Fastener

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants on Which Test Product Allowed for Proper Placement of the Subglottic Suction Lumen
Time Frame: Typical wear time of endotracheal tube fastener up to one week
Assessed by the proportion of yes/no researcher responses
Typical wear time of endotracheal tube fastener up to one week
Proportion of Participants on Which the Subglottic Suction Lumen Was Easy to Place Into the Tract With the Tube Protection Sleeve
Time Frame: Typical wear time of endotracheal tube fastener up to one week
Assessed by the proportion of researcher responses that equal agree (4) plus strongly agree (5) on a five point scale that includes strongly disagree (1) disagree (2) and no opinion (3)
Typical wear time of endotracheal tube fastener up to one week
Proportion of Participants on Which the Test Product Allowed the Subglottic Suction Lumen to Remain Within the Subglottic Suction Lumen Tract
Time Frame: Typical wear time of endotracheal tube fastener up to one week
Assessed by the proportion of yes/no researcher responses
Typical wear time of endotracheal tube fastener up to one week
Proportion of Participants on Which the Test Product Protected the Subglottic Suction Lumen
Time Frame: Typical wear time of endotracheal tube fastener up to one week
Assessed by the proportion of yes/no researcher responses
Typical wear time of endotracheal tube fastener up to one week
Proportion of Participants on Which the Test Product Allowed for Effective Subglottic Suctioning
Time Frame: Typical wear time of endotracheal tube fastener up to one week
Assessed by the proportion of yes/no researcher responses
Typical wear time of endotracheal tube fastener up to one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hollister Incorporated

Investigators

  • Study Chair: Paul Newton, JD, Legacy Research Institute IRB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

April 18, 2016

First Submitted That Met QC Criteria

May 2, 2016

First Posted (Estimate)

May 4, 2016

Study Record Updates

Last Update Posted (Actual)

September 6, 2018

Last Update Submitted That Met QC Criteria

August 9, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5799-I

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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