Assessment of a Oral Endotracheal Tube Fastener on Patients Intubated With Oral Endotracheal Tubes

• Sponsor: Hollister Incorporated (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02760927
• Collaborator: (none)
• Enrollment: 4
• Locations: 3
• Arm: 1
• Duration (Months): 2
• Patients Per Site: 1.3
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Respiratory Depression; Respiratory Failure; Ventilatory Depression	Device: Endotracheal Tube Fastener	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Assessment of AnchorFast Guard Oral Endotracheal Tube Fastener on Patients Intubated With Oral Endotracheal Tubes With Subglottic Suction
• Study Start Date: Mar 1, 2016
• Actual Primary Completion Date: Apr 1, 2016
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Endotracheal Tube Fastener 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; 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.; Other Names: AnchorFast Guard Oral Endotracheal Tube Fastener

Outcome Measures

Primary Outcome Measures

1. Proportion of Participants on Which Test Product Allowed for Proper Placement of the Subglottic Suction Lumen [Typical wear time of endotracheal tube fastener up to one week]

   Assessed by the proportion of yes/no researcher responses

2. Proportion of Participants on Which the Subglottic Suction Lumen Was Easy to Place Into the Tract With the Tube Protection Sleeve [Typical wear time of endotracheal tube fastener up to one week]

   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)

3. Proportion of Participants on Which the Test Product Allowed the Subglottic Suction Lumen to Remain Within the Subglottic Suction Lumen Tract [Typical wear time of endotracheal tube fastener up to one week]

   Assessed by the proportion of yes/no researcher responses

4. Proportion of Participants on Which the Test Product Protected the Subglottic Suction Lumen [Typical wear time of endotracheal tube fastener up to one week]

   Assessed by the proportion of yes/no researcher responses

5. Proportion of Participants on Which the Test Product Allowed for Effective Subglottic Suctioning [Typical wear time of endotracheal tube fastener up to one week]

   Assessed by the proportion of yes/no researcher responses

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Legacy Mt Hood	Gresham	Oregon	United States	97030
2	Legacy Good Samaritan	Portland	Oregon	United States	97210
3	Legacy Salmon Creek Medical Center	Vancouver	Washington	United States	98686

Sponsors and Collaborators

• Hollister Incorporated

Investigators

• Study Chair: Paul Newton, JD, Legacy Research Institute IRB

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hollister Incorporated
• ClinicalTrials.gov Identifier: NCT02760927
• Other Study ID Numbers: 5799-I
• First Posted: May 4, 2016
• Last Update Posted: Sep 6, 2018
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Respiratory Insufficiency; Depression; Depressive Disorder

Study Results

Participant Flow

Arm/Group Title	Endotracheal Tube Fastener
Arm/Group 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. Endotracheal Tube Fastener: 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.
Period Title: Overall Study
STARTED	4
COMPLETED	3
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Endotracheal Tube Fastener
Arm/Group 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. Endotracheal Tube Fastener: 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.
Overall Participants	4
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47 (18)
Sex: Female, Male (Count of Participants)
Female	2 50%
Male	2 50%
Race/Ethnicity, Customized (Count of Participants)
White (not of Hispanic origin)	3 75%
Asian or Pacific Islander	1 25%
Region of Enrollment (Count of Participants)
United States	4 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Intent-to-Treat

Arm/Group Title	Endotracheal Tube Fastener
Arm/Group 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. Endotracheal Tube Fastener: 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.
Measure Participants	4
Count of Participants [Participants]	4 100%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Intent-to-Treat

Arm/Group Title	Endotracheal Tube Fastener
Arm/Group 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. Endotracheal Tube Fastener: 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.
Measure Participants	4
Strongly Agree | Agree	3 75%
Strongly Disagree | Disagree | No opinion	1 25%

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Intent-to-Treat

Arm/Group Title	Endotracheal Tube Fastener
Arm/Group 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. Endotracheal Tube Fastener: 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.
Measure Participants	4
Yes	3 75%
No (Thick secretions)	1 25%

4. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Intent-to-Treat

Arm/Group Title	Endotracheal Tube Fastener
Arm/Group 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. Endotracheal Tube Fastener: 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.
Measure Participants	4
Yes	3 75%
No (Removed with thick secretions)	1 25%

5. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Intent-to-Treat

Arm/Group Title	Endotracheal Tube Fastener
Arm/Group 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. Endotracheal Tube Fastener: 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.
Measure Participants	4
Yes	3 75%
No (Thick secretions)	1 25%

Adverse Events

Arm/Group Title	Endotracheal Tube Fastener
Arm/Group 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. Endotracheal Tube Fastener: 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.
All Cause Mortality
	Endotracheal Tube Fastener
	Affected / at Risk (%)	# Events
Total	0/4 (0%)
Serious Adverse Events
	Endotracheal Tube Fastener
	Affected / at Risk (%)	# Events
Total	0/4 (0%)
Other (Not Including Serious) Adverse Events
	Endotracheal Tube Fastener
	Affected / at Risk (%)	# Events
Total	2/4 (50%)
Product Issues
Device-associated tongue displacement	2/4 (50%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Results of the trial are the exclusive and sole property of the Sponsor, and the Sponsor has the right to publish the results of the trial. Publication of results or release by the PI of information obtained for the Sponsor requires previous written approval and authorization by the Sponsor.