Back to resultsAssessment of a Oral Endotracheal Tube Fastener on Patients Intubated With Oral Endotracheal Tubes
Primary Purpose
Respiratory Depression, Respiratory Failure, Ventilatory Depression
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Endotracheal Tube Fastener
Sponsored by
About this trial
This is an interventional supportive care trial for Respiratory Depression
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Legacy Mt Hood
- Legacy Good Samaritan
- Legacy Salmon Creek Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Endotracheal Tube Fastener
Arm Description
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.
Outcomes
Primary Outcome Measures
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
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)
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
Proportion of Participants on Which the Test Product Protected the Subglottic Suction Lumen
Assessed by the proportion of yes/no researcher responses
Proportion of Participants on Which the Test Product Allowed for Effective Subglottic Suctioning
Assessed by the proportion of yes/no researcher responses
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02760927
Brief Title
Assessment of a Oral Endotracheal Tube Fastener on Patients Intubated With Oral Endotracheal Tubes
Official Title
Assessment of AnchorFast Guard Oral Endotracheal Tube Fastener on Patients Intubated With Oral Endotracheal Tubes With Subglottic Suction
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
Study product will not be commercialized.
Study Start Date
March 2016 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hollister Incorporated
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Assessment of AnchorFast Guard Oral Endotracheal Tube Fastener on Patients Intubated with Oral Endotracheal Tubes with Subglottic Suction
Detailed Description
Endotracheal intubation is the trans laryngeal placement of a tube into the trachea via the nose or mouth. Subglottic suctioning, during endotracheal tube securement, is important for mechanically-ventilated patients to allow for the clearance of secretions that may accumulate during intubation. This protocol examines an enhancement to the current AnchorFast Guard device in order for the device to hold a subglottic suctioning lumen in addition to the intubation tube.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Depression, Respiratory Failure, Ventilatory Depression
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endotracheal Tube Fastener
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Endotracheal Tube Fastener
Other Intervention Name(s)
AnchorFast Guard Oral Endotracheal Tube Fastener
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of Participants on Which Test Product Allowed for Proper Placement of the Subglottic Suction Lumen
Description
Assessed by the proportion of yes/no researcher responses
Time Frame
Typical wear time of endotracheal tube fastener up to one week
Title
Proportion of Participants on Which the Subglottic Suction Lumen Was Easy to Place Into the Tract With the Tube Protection Sleeve
Description
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)
Time Frame
Typical wear time of endotracheal tube fastener up to one week
Title
Proportion of Participants on Which the Test Product Allowed the Subglottic Suction Lumen to Remain Within the Subglottic Suction Lumen Tract
Description
Assessed by the proportion of yes/no researcher responses
Time Frame
Typical wear time of endotracheal tube fastener up to one week
Title
Proportion of Participants on Which the Test Product Protected the Subglottic Suction Lumen
Description
Assessed by the proportion of yes/no researcher responses
Time Frame
Typical wear time of endotracheal tube fastener up to one week
Title
Proportion of Participants on Which the Test Product Allowed for Effective Subglottic Suctioning
Description
Assessed by the proportion of yes/no researcher responses
Time Frame
Typical wear time of endotracheal tube fastener up to one week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Newton, JD
Organizational Affiliation
Legacy Research Institute IRB
Official's Role
Study Chair
Facility Information:
Facility Name
Legacy Mt Hood
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
Legacy Good Samaritan
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Legacy Salmon Creek Medical Center
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98686
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessment of a Oral Endotracheal Tube Fastener on Patients Intubated With Oral Endotracheal Tubes
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