NCT01651260

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

5 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

Study Start

First participant enrolled

July 1, 2012

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 27, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

October 28, 2015

Completed
Last Updated

March 23, 2016

Status Verified

February 1, 2016

Enrollment Period

7 months

First QC Date

July 16, 2012

Results QC Date

March 18, 2014

Last Update Submit

February 23, 2016

Conditions

Respiratory Insufficiency

Outcome Measures

Primary Outcomes (1)

  • Prevention of Damage and/or Occlusion of Endotracheal (ET) Tube During Use

    Number of participants with damage of ET tube and Number of participants with occlusion of ET tube

    14 days

Secondary Outcomes (1)

  • Ease of Use

    Between 1 - 14 days

Study Arms (1)

Endotracheal (ET) tube securement device

OTHER

Single arm study evaluated an experimental ET tube securement device with a bite block.

Other: Experimental ET Tube Securement Device

Interventions

Experimental ET Tube Securement DeviceOTHER

Experimental Hollister device with bite block was substituted for standard-of-care device during the study period.

Also known as: AnchorFast Guard® ET tube securement device
Endotracheal (ET) tube securement device

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; 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

St. Joseph's Hospitals

Tampa, Florida, 33607, United States

Location

Legacy Good Samaritan

Portland, Oregon, 97210, United States

Location

Legacy Salmon Creek Medical Center

Vancouver, Washington, 98686, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Limitations and Caveats

Adult subjects in respiratory insufficiency in ICU setting were intubated with only four ET tube sizes: 7.0, 7.5, 8.0 and 8.5 mm. No other sizes were represented in the sample population.

Results Point of Contact

Title
Malford Cullum
Organization
Hollister Incorporated
malford.cullum@Hollister.com
847-918-3975

Study Officials

  • Elizabeth Konz, PhD

    Hollister Incorporated

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

July 16, 2012

First Posted

July 27, 2012

Study Start

July 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

March 23, 2016

Results First Posted

October 28, 2015

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

US(5)