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Assessment of an Oral Endotracheal Subglottic Tube Holder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03328182
Recruitment Status : Completed
First Posted : November 1, 2017
Results First Posted : July 5, 2019
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
Hollister Incorporated

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

Condition or disease Intervention/treatment Phase
Intubation Device: New oral endotracheal tube holder Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Assessment of AnchorFast Guard Subglottic ET (Endotracheal) Tube
Actual Study Start Date : October 23, 2017
Actual Primary Completion Date : June 8, 2018
Actual Study Completion Date : June 15, 2018

Arm Intervention/treatment
Experimental: New oral endotracheal tube holder
Single Study Product Arm
Device: New oral endotracheal tube holder
The single arm study product is designed to hold a standard or subglottic ET tube.




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

  1. Is 18 years of age or older and require oral tracheal intubation with subglottic ET tube size 6.0-8.0mm
  2. Requires the use of a bite block per the hospital's standard of care
  3. Has intact skin on and around application site, including cheeks and lips
  4. Oral cavity is free of open sores, ulcers, wounds, and lesions
  5. Subject or Legal Authorized representative (LAR) able to provide informed consent for the study
  6. Is qualified to participate in the opinion of the Investigator, or designee

EXCLUSION CRITERIA

  1. Has actual or perceived loose teeth, is without teeth, or is unable to wear upper dentures
  2. Has facial hair that interferes with the adhesion of the skin barrier pads
  3. 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
  4. Has a medical condition, surgery or a procedure that prevents the proper application of the device, including placement of the neck strap.
  5. Has a known or stated allergy to adhesives
  6. Currently is participating in any clinical study which may affect the performance of the device

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03328182


Locations
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United States, California
Community Regional Medical Center
Fresno, California, United States, 93701
United States, Oregon
Legacy Mount Hood Medical Center
Gresham, Oregon, United States, 97030
Legacy Good Samaritan Medical Center
Portland, Oregon, United States, 97210
Legacy Emanuel Hospital & Health Center
Portland, Oregon, United States, 97227
Sponsors and Collaborators
Hollister Incorporated
Investigators
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Principal Investigator: Laura Vander Werff, MD Legacy Mount Hood Medical Center
Principal Investigator: Brian Young, MD 1. Legacy Emanuel Hospital & Health Center 2. Legacy Good Samaritan Medical Center
Principal Investigator: Arash Afshinnik, MD Community Regional Medical Center
  Study Documents (Full-Text)

Documents provided by Hollister Incorporated:
Publications:
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Responsible Party: Hollister Incorporated
ClinicalTrials.gov Identifier: NCT03328182    
Other Study ID Numbers: 5855-I
First Posted: November 1, 2017    Key Record Dates
Results First Posted: July 5, 2019
Last Update Posted: July 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No