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Assessment of an Oral Endotracheal Subglottic Tube Holder

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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

Tracking Information
First Submitted Date  ICMJE October 16, 2017
First Posted Date  ICMJE November 1, 2017
Results First Submitted Date  ICMJE April 11, 2019
Results First Posted Date  ICMJE July 5, 2019
Last Update Posted Date July 5, 2019
Actual Study Start Date  ICMJE October 23, 2017
Actual Primary Completion Date June 8, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2019)
  • 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
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 27, 2017)
  • 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.
  • Usability of Study Product [ Time Frame: At application, during use and at product removal (maximum 29 days of patient wearing product) ]
    The usability of the study product at application, during use and at removal will be rated with a 5-point Likert scale
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of an Oral Endotracheal Subglottic Tube Holder
Official Title  ICMJE Assessment of AnchorFast Guard Subglottic ET (Endotracheal) Tube
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Intubation
Intervention  ICMJE Device: New oral endotracheal tube holder
The single arm study product is designed to hold a standard or subglottic ET tube.
Study Arms  ICMJE Experimental: New oral endotracheal tube holder
Single Study Product Arm
Intervention: Device: New oral endotracheal tube holder
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 1, 2018)
34
Original Estimated Enrollment  ICMJE
 (submitted: October 27, 2017)
30
Actual Study Completion Date  ICMJE June 15, 2018
Actual Primary Completion Date June 8, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03328182
Other Study ID Numbers  ICMJE 5855-I
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hollister Incorporated
Study Sponsor  ICMJE Hollister Incorporated
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Hollister Incorporated
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP