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Assessment of an Endotracheal Tube Securement Device

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ClinicalTrials.gov Identifier: NCT01651260
Recruitment Status : Completed
First Posted : July 27, 2012
Results First Posted : October 28, 2015
Last Update Posted : March 23, 2016
Sponsor:
Information provided by (Responsible Party):
Hollister Incorporated

Tracking Information
First Submitted Date  ICMJE July 16, 2012
First Posted Date  ICMJE July 27, 2012
Results First Submitted Date  ICMJE March 18, 2014
Results First Posted Date  ICMJE October 28, 2015
Last Update Posted Date March 23, 2016
Study Start Date  ICMJE July 2012
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2016)
Prevention of Damage and/or Occlusion of Endotracheal (ET) Tube During Use [ Time Frame: 14 days ]
Number of participants with damage of ET tube and Number of participants with occlusion of ET tube
Original Primary Outcome Measures  ICMJE
 (submitted: July 24, 2012)
Assess devices ability to protect the endotracheal tube [ Time Frame: Between 1-14 days ]
Number of participants who experienced damage to the endotracheal tube. Number of participants who experienced occlusion of endotracheal tube.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2015)
Ease of Use [ Time Frame: Between 1 - 14 days ]
Likert scale score provided by clinician (1 very difficult, 2 difficult, 3 neither easy nor difficult, 4 easy, 5 very easy);
Original Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2012)
Assess acceptability of use through clinician assessment of device characteristics [ Time Frame: Between 1 - 14 days ]
Ease of application, removal, and maintaining, and overall acceptability to clinicians using a Likert scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of an Endotracheal Tube Securement Device
Official Title  ICMJE Assessment of the Functionality and Performance of an Endotracheal (ET) Tube Protection Device
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.
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: Supportive Care
Condition  ICMJE Respiratory Insufficiency
Intervention  ICMJE Other: Experimental ET Tube Securement Device
Experimental Hollister device with bite block was substituted for standard-of-care device during the study period.
Other Name: AnchorFast Guard® ET tube securement device
Study Arms  ICMJE Endotracheal (ET) tube securement device
Single arm study evaluated an experimental ET tube securement device with a bite block.
Intervention: Other: Experimental ET Tube Securement Device
Publications * Not Provided

*   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: September 22, 2015)
65
Original Estimated Enrollment  ICMJE
 (submitted: July 24, 2012)
68
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
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 NCT01651260
Other Study ID Numbers  ICMJE 5156-I
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hollister Incorporated
Study Sponsor  ICMJE Hollister Incorporated
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Elizabeth Konz, PhD Hollister Incorporated
PRS Account Hollister Incorporated
Verification Date February 2016

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