NCT02760927

Brief Summary

Assessment of AnchorFast Guard Oral Endotracheal Tube Fastener on Patients Intubated with Oral Endotracheal Tubes with Subglottic Suction

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
terminated

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

March 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2016

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 4, 2016

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

September 6, 2018

Completed
Last Updated

September 6, 2018

Status Verified

August 1, 2018

Enrollment Period

1 month

First QC Date

April 18, 2016

Results QC Date

August 9, 2018

Last Update Submit

August 9, 2018

Conditions

Respiratory DepressionRespiratory FailureVentilatory Depression

Outcome Measures

Primary Outcomes (5)

  • Proportion of Participants on Which Test Product Allowed for Proper Placement of the Subglottic Suction Lumen

    Assessed by the proportion of yes/no researcher responses

    Typical wear time of endotracheal tube fastener up to one week

  • Proportion of Participants on Which the Subglottic Suction Lumen Was Easy to Place Into the Tract With the Tube Protection Sleeve

    Assessed by the proportion of researcher responses that equal agree (4) plus strongly agree (5) on a five point scale that includes strongly disagree (1) disagree (2) and no opinion (3)

    Typical wear time of endotracheal tube fastener up to one week

  • Proportion of Participants on Which the Test Product Allowed the Subglottic Suction Lumen to Remain Within the Subglottic Suction Lumen Tract

    Assessed by the proportion of yes/no researcher responses

    Typical wear time of endotracheal tube fastener up to one week

  • Proportion of Participants on Which the Test Product Protected the Subglottic Suction Lumen

    Assessed by the proportion of yes/no researcher responses

    Typical wear time of endotracheal tube fastener up to one week

  • Proportion of Participants on Which the Test Product Allowed for Effective Subglottic Suctioning

    Assessed by the proportion of yes/no researcher responses

    Typical wear time of endotracheal tube fastener up to one week

Study Arms (1)

Endotracheal Tube Fastener

EXPERIMENTAL

The intervention administered is a revised commercially available endotracheal tube holder with a tract to accommodate a subglottic suction lumen of an oral endotracheal tube.

Device: Endotracheal Tube Fastener

Interventions

Endotracheal Tube FastenerDEVICE

The AnchorFast Guard oral endotracheal tube fastener provides a convenient means to hold an oral endotracheal tube securely in place without the use of adhesive tape. The oral endotracheal tube fastener allows repositioning of the tube in either direction along the track without removal of the device.

Also known as: AnchorFast Guard Oral Endotracheal Tube Fastener
Endotracheal Tube Fastener

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 requires oral tracheal intubation
  • Has intact skin on application site
  • Is qualified to participate in the opinion of the Investigator including the requirement for endotracheal tube with subglottic suction

You may not qualify if:

  • Has an existing neck injury
  • Has protruding upper teeth, is without teeth or is unable to wear upper dentures
  • Has facial hair
  • Has clinically significant skin damage, condition or disease on the application site which may contraindicate participation
  • Has a known or stated allergy to adhesive bandages, or any of the product types being tested
  • Uses of topical drugs, lotions, creams or oils on the application site
  • Is participating in any clinical testing which may affect performance of this device
  • AnchorFast Guard Oral Endotracheal Tube Fastener does not fit subject's face

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Legacy Mt Hood

Gresham, Oregon, 97030, 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

Results Point of Contact

Title
Stacy Haddad, Director Global Clinical Affairs
Organization
Hollister Incorporated
stacy.haddad@hollister.com
+1.847.680.2837

Study Officials

  • Paul Newton, JD

    Legacy Research Institute IRB

    STUDY CHAIR

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
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2016

First Posted

May 4, 2016

Study Start

March 1, 2016

Primary Completion

April 1, 2016

Study Completion

May 1, 2016

Last Updated

September 6, 2018

Results First Posted

September 6, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

US(3)