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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

July 16, 2012
July 27, 2012
March 18, 2014
October 28, 2015
March 23, 2016
July 2012
February 2013   (Final data collection date for primary outcome measure)
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
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.
Complete list of historical versions of study NCT01651260 on ClinicalTrials.gov Archive Site
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);
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
Not Provided
Not Provided
 
Assessment of an Endotracheal Tube Securement Device
Assessment of the Functionality and Performance of an Endotracheal (ET) Tube Protection Device
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.
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.
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Respiratory Insufficiency
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
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
68
February 2013
February 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01651260
5156-I
No
Not Provided
Plan to Share IPD: No
Hollister Incorporated
Hollister Incorporated
Not Provided
Study Chair: Elizabeth Konz, PhD Hollister Incorporated
Hollister Incorporated
February 2016

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