Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Assessment of an Endotracheal Tube Securement Device

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hollister Incorporated
ClinicalTrials.gov Identifier:
NCT01651260
First received: July 16, 2012
Last updated: February 23, 2016
Last verified: February 2016
  Purpose
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.

Condition Intervention
Respiratory Insufficiency
Other: Experimental ET Tube Securement Device

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Assessment of the Functionality and Performance of an Endotracheal (ET) Tube Protection Device

Further study details as provided by Hollister Incorporated:

Primary Outcome Measures:
  • Prevention of Damage and/or Occlusion of Endotracheal (ET) Tube During Use [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Number of participants with damage of ET tube and Number of participants with occlusion of ET tube


Secondary Outcome Measures:
  • Ease of Use [ Time Frame: Between 1 - 14 days ] [ Designated as safety issue: No ]
    Likert scale score provided by clinician (1 very difficult, 2 difficult, 3 neither easy nor difficult, 4 easy, 5 very easy);


Enrollment: 65
Study Start Date: July 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Endotracheal (ET) tube securement device
Single arm study evaluated an experimental ET tube securement device with a bite block.
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01651260

Locations
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
United States, District of Columbia
Medstar Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
St. Joseph's Hospitals
Tampa, Florida, United States, 33607
United States, Oregon
Legacy Good Samaritan
Portland, Oregon, United States, 97210
United States, Washington
Legacy Salmon Creek Medical Center
Vancouver, Washington, United States, 98686
Sponsors and Collaborators
Hollister Incorporated
Investigators
Study Chair: Elizabeth Konz, PhD Hollister Incorporated
  More Information

Responsible Party: Hollister Incorporated
ClinicalTrials.gov Identifier: NCT01651260     History of Changes
Other Study ID Numbers: 5156-I 
Study First Received: July 16, 2012
Results First Received: March 18, 2014
Last Updated: February 23, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 28, 2016