Trial Outcomes & Findings for Assessment of a Oral Endotracheal Tube Fastener on Patients Intubated With Oral Endotracheal Tubes (NCT NCT02760927)
NCT ID: NCT02760927
Last Updated: 2018-09-06
Results Overview
Assessed by the proportion of yes/no researcher responses
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
4 participants
Primary outcome timeframe
Typical wear time of endotracheal tube fastener up to one week
Results posted on
2018-09-06
Participant Flow
Participant milestones
| Measure |
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.
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.
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|---|---|
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Overall Study
STARTED
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4
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Overall Study
COMPLETED
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3
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
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.
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.
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|---|---|
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Overall Study
Tube Slippage from Device
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1
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Baseline Characteristics
Assessment of a Oral Endotracheal Tube Fastener on Patients Intubated With Oral Endotracheal Tubes
Baseline characteristics by cohort
| Measure |
Endotracheal Tube Fastener
n=4 Participants
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.
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|---|---|
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Age, Continuous
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47 years
STANDARD_DEVIATION 18 • n=99 Participants
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Sex: Female, Male
Female
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2 Participants
n=99 Participants
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Sex: Female, Male
Male
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2 Participants
n=99 Participants
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Race/Ethnicity, Customized
Race/Ethic Heritage · White (not of Hispanic origin)
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3 Participants
n=99 Participants
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Race/Ethnicity, Customized
Race/Ethic Heritage · Asian or Pacific Islander
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1 Participants
n=99 Participants
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Region of Enrollment
United States
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4 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: Typical wear time of endotracheal tube fastener up to one weekPopulation: Intent-to-Treat
Assessed by the proportion of yes/no researcher responses
Outcome measures
| Measure |
Endotracheal Tube Fastener
n=4 Participants
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.
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|---|---|
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Proportion of Participants on Which Test Product Allowed for Proper Placement of the Subglottic Suction Lumen
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4 Participants
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PRIMARY outcome
Timeframe: Typical wear time of endotracheal tube fastener up to one weekPopulation: Intent-to-Treat
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)
Outcome measures
| Measure |
Endotracheal Tube Fastener
n=4 Participants
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.
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|---|---|
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Proportion of Participants on Which the Subglottic Suction Lumen Was Easy to Place Into the Tract With the Tube Protection Sleeve
Strongly Agree | Agree
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3 Participants
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Proportion of Participants on Which the Subglottic Suction Lumen Was Easy to Place Into the Tract With the Tube Protection Sleeve
Strongly Disagree | Disagree | No opinion
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1 Participants
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PRIMARY outcome
Timeframe: Typical wear time of endotracheal tube fastener up to one weekPopulation: Intent-to-Treat
Assessed by the proportion of yes/no researcher responses
Outcome measures
| Measure |
Endotracheal Tube Fastener
n=4 Participants
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.
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|---|---|
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Proportion of Participants on Which the Test Product Allowed the Subglottic Suction Lumen to Remain Within the Subglottic Suction Lumen Tract
Yes
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3 Participants
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Proportion of Participants on Which the Test Product Allowed the Subglottic Suction Lumen to Remain Within the Subglottic Suction Lumen Tract
No (Thick secretions)
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1 Participants
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PRIMARY outcome
Timeframe: Typical wear time of endotracheal tube fastener up to one weekPopulation: Intent-to-Treat
Assessed by the proportion of yes/no researcher responses
Outcome measures
| Measure |
Endotracheal Tube Fastener
n=4 Participants
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.
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|---|---|
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Proportion of Participants on Which the Test Product Protected the Subglottic Suction Lumen
Yes
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3 Participants
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Proportion of Participants on Which the Test Product Protected the Subglottic Suction Lumen
No (Removed with thick secretions)
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1 Participants
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PRIMARY outcome
Timeframe: Typical wear time of endotracheal tube fastener up to one weekPopulation: Intent-to-Treat
Assessed by the proportion of yes/no researcher responses
Outcome measures
| Measure |
Endotracheal Tube Fastener
n=4 Participants
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.
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|---|---|
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Proportion of Participants on Which the Test Product Allowed for Effective Subglottic Suctioning
Yes
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3 Participants
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Proportion of Participants on Which the Test Product Allowed for Effective Subglottic Suctioning
No (Thick secretions)
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1 Participants
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Adverse Events
Endotracheal Tube Fastener
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Endotracheal Tube Fastener
n=4 participants at risk
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.
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|---|---|
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Product Issues
Device-associated tongue displacement
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50.0%
2/4 • Number of events 2
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Additional Information
Stacy Haddad, Director Global Clinical Affairs
Hollister Incorporated
Phone: +1.847.680.2837
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER