NCT03328182

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

October 23, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2018

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 5, 2019

Completed
Last Updated

July 5, 2019

Status Verified

April 1, 2019

Enrollment Period

8 months

First QC Date

October 16, 2017

Results QC Date

April 11, 2019

Last Update Submit

July 2, 2019

Conditions

Intubation

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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)

Study Arms (1)

New oral endotracheal tube holder

EXPERIMENTAL

Single Study Product Arm

Device: New oral endotracheal tube holder

Interventions

New oral endotracheal tube holderDEVICE

The single arm study product is designed to hold a standard or subglottic ET tube.

New oral endotracheal tube holder

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Is 18 years of age or older and require oral tracheal intubation with subglottic ET tube size 6.0-8.0mm
  • Requires the use of a bite block per the hospital's standard of care
  • Has intact skin on and around application site, including cheeks and lips
  • Oral cavity is free of open sores, ulcers, wounds, and lesions
  • Subject or Legal Authorized representative (LAR) able to provide informed consent for the study
  • Is qualified to participate in the opinion of the Investigator, or designee

You may not qualify if:

  • Has actual or perceived loose teeth, is without teeth, or is unable to wear upper dentures
  • Has facial hair that interferes with the adhesion of the skin barrier pads
  • 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
  • Has a medical condition, surgery or a procedure that prevents the proper application of the device, including placement of the neck strap.
  • Has a known or stated allergy to adhesives
  • Currently is participating in any clinical study which may affect the performance of the device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Community Regional Medical Center

Fresno, California, 93701, United States

Location

Legacy Mount Hood Medical Center

Gresham, Oregon, 97030, United States

Location

Legacy Good Samaritan Medical Center

Portland, Oregon, 97210, United States

Location

Legacy Emanuel Hospital & Health Center

Portland, Oregon, 97227, United States

Location

Related Publications (2)

  • Buckley JC, Brown AP, Shin JS, Rogers KM, Hoftman NN. A Comparison of the Haider Tube-Guard(R) 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.

    PMID: 26983051BACKGROUND

  • 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

    BACKGROUND

Results Point of Contact

Title
Director Global Clinical Affairs
Organization
Hollister Incorporated
stacy.haddad@hollister.com
8476802837

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2017

First Posted

November 1, 2017

Study Start

October 23, 2017

Primary Completion

June 8, 2018

Study Completion

June 15, 2018

Last Updated

July 5, 2019

Results First Posted

July 5, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(4)