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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03328182
Other study ID # 5855-I
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 23, 2017
Est. completion date June 15, 2018

Study information

Verified date April 2019
Source Hollister Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date June 15, 2018
Est. primary completion date June 8, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
New oral endotracheal tube holder
The single arm study product is designed to hold a standard or subglottic ET tube.

Locations

Country Name City State
United States Community Regional Medical Center Fresno California
United States Legacy Mount Hood Medical Center Gresham Oregon
United States Legacy Emanuel Hospital & Health Center Portland Oregon
United States Legacy Good Samaritan Medical Center Portland Oregon

Sponsors (1)

Lead Sponsor Collaborator
Hollister Incorporated

Country where clinical trial is conducted

United States, 

References & Publications (2)

Buckley JC, Brown AP, Shin JS, Rogers KM, Hoftman NN. A Comparison of the Haider Tube-Guard® Endotracheal Tube Holder Versus Adhesive Tape to Determine if This Novel Device Can Reduce Endotracheal Tube Movement and Prevent Unplanned Extubation. Anesth Analg. 2016 May;122(5):1439-43. doi: 10.1213/ANE.0000000000001222. — View Citation

Mohammed, H & Hassan, M. (2015). Endotracheal tube securements: Effectiveness of three techniques among orally intubated patients. Egyptian Journal of Chest Diseases and Tuberculosis 64:183-196

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Acceptability With Study 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 At product removal (maximum 29 days of patient wearing product)
Primary Usability of Study Product The usability of the study product at application and at removal. At application and product removal (maximum 29 days of patient wearing product)
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