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Assessment of an Endotracheal Tube Securement Device

Primary Purpose

Respiratory Insufficiency

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental ET Tube Securement Device
Sponsored by
Hollister Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Respiratory Insufficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hartford Hospital
  • Medstar Washington Hospital Center
  • St. Joseph's Hospitals
  • Legacy Good Samaritan
  • Legacy Salmon Creek Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Endotracheal (ET) tube securement device

Arm Description

Single arm study evaluated an experimental ET tube securement device with a bite block.

Outcomes

Primary Outcome Measures

Prevention of Damage and/or Occlusion of Endotracheal (ET) Tube During Use
Number of participants with damage of ET tube and Number of participants with occlusion of ET tube

Secondary Outcome Measures

Ease of Use
Likert scale score provided by clinician (1 very difficult, 2 difficult, 3 neither easy nor difficult, 4 easy, 5 very easy);

Full Information

First Posted
July 16, 2012
Last Updated
February 23, 2016
Sponsor
Hollister Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01651260
Brief Title
Assessment of an Endotracheal Tube Securement Device
Official Title
Assessment of the Functionality and Performance of an Endotracheal (ET) Tube Protection Device
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hollister Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endotracheal (ET) tube securement device
Arm Type
Other
Arm Description
Single arm study evaluated an experimental ET tube securement device with a bite block.
Intervention Type
Other
Intervention Name(s)
Experimental ET Tube Securement Device
Other Intervention Name(s)
AnchorFast Guard® ET tube securement device
Intervention Description
Experimental Hollister device with bite block was substituted for standard-of-care device during the study period.
Primary Outcome Measure Information:
Title
Prevention of Damage and/or Occlusion of Endotracheal (ET) Tube During Use
Description
Number of participants with damage of ET tube and Number of participants with occlusion of ET tube
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Ease of Use
Description
Likert scale score provided by clinician (1 very difficult, 2 difficult, 3 neither easy nor difficult, 4 easy, 5 very easy);
Time Frame
Between 1 - 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Konz, PhD
Organizational Affiliation
Hollister Incorporated
Official's Role
Study Chair
Facility Information:
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
Medstar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
St. Joseph's Hospitals
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Legacy Good Samaritan
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Legacy Salmon Creek Medical Center
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98686
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Assessment of an Endotracheal Tube Securement Device

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