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Study product will not be commercialized.
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Assessment of AnchorFast Guard Oral Endotracheal Tube Fastener on Patients Intubated with Oral Endotracheal Tubes with Subglottic Suction
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endotracheal Tube Fastener | Device | 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 | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Newton, JD | Legacy Research Institute IRB | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Legacy Mt Hood | Gresham | Oregon | 97030 | United States | ||
| Legacy Good Samaritan |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Intent-to-Treat principles followed. All four subjects were included in the analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Intent-to-Treat | Posted | Count of Participants | Participants | Typical wear time of endotracheal tube fastener up to one week |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device-associated tongue displacement | Product Issues | Systematic Assessment | Device-associated tongue displacement |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stacy Haddad, Director Global Clinical Affairs | Hollister Incorporated | +1.847.680.2837 | stacy.haddad@hollister.com |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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|
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| Portland |
| Oregon |
| 97210 |
| United States |
| Legacy Salmon Creek Medical Center | Vancouver | Washington | 98686 | United States |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Primary | 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) | Intent-to-Treat | Posted | Count of Participants | Participants | Typical wear time of endotracheal tube fastener up to one week |
|
|
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| Primary | 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 | Intent-to-Treat | Posted | Count of Participants | Participants | Typical wear time of endotracheal tube fastener up to one week |
|
|
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| Primary | Proportion of Participants on Which the Test Product Protected the Subglottic Suction Lumen | Assessed by the proportion of yes/no researcher responses | Intent-to-Treat | Posted | Count of Participants | Participants | Typical wear time of endotracheal tube fastener up to one week |
|
|
|
| Primary | Proportion of Participants on Which the Test Product Allowed for Effective Subglottic Suctioning | Assessed by the proportion of yes/no researcher responses | Intent-to-Treat | Posted | Count of Participants | Participants | Typical wear time of endotracheal tube fastener up to one week |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 2 |
| 4 |
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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.