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This is a prospective, single-blinded, randomized study to assess the ability of taping methods used to secure intravenous (IV) catheters to resist the IV from being pulled away from the skin. Participants will have IV catheters taped on top of the skin (without insertion into the skin) using three taping methods, BCH Emergency Department (BCH ED), Chevron, and our novel method. Six measurements will be obtained per subject (3 random taping methods measuring their resistance to force in two directions, retrograde direction or towards the wrist and 90-degree angle to the arm).
Accidental removal of IV catheters delay patient care and can cause additional medical anxiety and pain that is heightened in the pediatric population. Moreover, such failed catheters create an increased burden economically and emotionally to patients, hospitals, and clinicians. To facilitate the most accurate, consistent results, a calibrated hand wheel test stand with a force gauge will be used to obtain force measurements. We will obtain the amount of force is required to remove the IV catheter form the skin of the subjects to compare the three taping measurements in two different directions. The retrograde direction will be pulling the IV distally from the IV site, towards the participant's wrist. The 90-degree angle will be pulling the IV medially away from the IV site.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrograde Directional Test | Active Comparator | Subjects during the Retrograde Directional Test will have the three taping methods placed on their left and/or right antecubital fossa region to superficially secure an IV catheter (i.e., the catheter will be placed on top of the participant's skin and not in the vein but will be taped as if the catheter was placed intravenously). Six total measurements will be obtained of which three will be using the Retrograde Directional Test (i.e., each taping method will undergo testing for each directional method). The order of placing the different taping methods and the direction testing will be randomized. |
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| 90 Degrees Directional Test | Active Comparator | Subjects during the 90 Degrees Directional Test will have the three taping methods placed on their left and right antecubital fossa region, superficially taping an IV catheter (i.e., the catheter will be placed on top of the participant's skin and not in the vein but will be taped as if the catheter was placed intravenously). Six total measurements will be obtained of which three will be using the 90 Degrees Directional Test (i.e., each taping method will undergo testing for each directional method). The order of placing the different taping methods and the direction testing will be randomized. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel Taping Method | Device | Subjects will be asked to have the novel taping method placed on their left and right antecubital fossa region, superficially taping an IV catheter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Force (Newtons) Required to Dislodge an IV Catheter Secured in the Retrograde Direction. | We will examine the maximum force the taping methods can withstand as measured by the force gauge in the retrograde direction, distally from the insertion site. | Until the tape is dislodged- approximately 15 seconds |
| The Force (Newtons) Required to Dislodge an IV Catheter Secured in a 90 Degrees Direction. | We will examine the maximum force the taping methods can withstand as measured by the force gauge in a 90 degrees direction, medially from the insertion site. | Until the tape is dislodged- approximately 15 seconds |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pete Kovatsis, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
The data is not publicly available due to patient privacy concerns. Data can be made available upon reasonable request and after ethical/data sharing agreements are met.
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| ID | Title | Description |
|---|---|---|
| FG000 | Retrograde Directional Test | Subjects during the Retrograde Directional Test will have the three taping methods placed on their left and/or right antecubital fossa region to superficially secure an IV catheter (i.e., the catheter will be placed on top of the participant's skin and not in the vein but will be taped as if the catheter was placed intravenously). Six total measurements will be obtained of which three will be using the Retrograde Directional Test (i.e., each taping method will undergo testing for each directional method). The order of placing the different taping methods and the direction testing will be randomized. |
| FG001 | 90 Degrees Directional Test | Subjects during the 90 Degrees Directional Test will have the three taping methods placed on their left and right antecubital fossa region, superficially taping an IV catheter (i.e., the catheter will be placed on top of the participant's skin and not in the vein but will be taped as if the catheter was placed intravenously). Six total measurements will be obtained of which three will be using the 90 Degrees Directional Test (i.e., each taping method will undergo testing for each directional method). The order of placing the different taping methods and the direction testing will be randomized. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Numbers represent number of participants randomized to start with retrograde directional test or 90 degrees directional test. All participants cross-overed and therefore, were subjected to both tests regardless of randomization.
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| ID | Title | Description |
|---|---|---|
| BG000 | Retrograde Directional Test | Subjects during the Retrograde Directional Test will have the three taping methods placed on their left and/or right antecubital fossa region to superficially secure an IV catheter (i.e., the catheter will be placed on top of the participant's skin and not in the vein but will be taped as if the catheter was placed intravenously). Six total measurements will be obtained of which three will be using the Retrograde Directional Test (i.e., each taping method will undergo testing for each directional method). The order of placing the different taping methods and the direction testing will be randomized. Novel Taping Method: Subjects will be asked to have the novel taping method placed on their left and right antecubital fossa region, superficially taping an IV catheter. BCH Emergency Department Taping Method: Subjects will be asked to have the BCH emergency department taping method placed on their left and right antecubital fossa region, superficially taping an IV catheter. Chevron Taping Method: Subjects will be asked to have the Chevron taping method placed on their left and right antecubital fossa region, superficially taping an IV catheter. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Numbers represent number of participants randomized to start with retrograde directional test or 90 degrees directional test. All participants cross-overed and therefore, were subjected to both tests regardless of randomization. |
| 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 | The Force (Newtons) Required to Dislodge an IV Catheter Secured in the Retrograde Direction. | We will examine the maximum force the taping methods can withstand as measured by the force gauge in the retrograde direction, distally from the insertion site. | Posted | Mean | Standard Deviation | Newtons | Until the tape is dislodged- approximately 15 seconds |
|
Through study completion, 1 day
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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 | Retrograde Directional Test: Novel Taping | The novel taping method will be employed to measure the maximum force (Newtons) required to dislodge an IV catheter (without puncturing of skin) secured in the retrograde direction, distally from the insertion site. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pete Kovatsis | Boston Children's Hospital | 617-355-6225 | pete.kovatsis@childrens.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 21, 2023 | Jan 5, 2026 | Prot_SAP_000.pdf |
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The research team member placing the tape was blinded from the measurements obtained, and the research team member obtaining the measurements was blinded from the tape that was placed.
| BCH Emergency Department Taping Method | Device | Subjects will be asked to have the BCH emergency department taping method placed on their left and right antecubital fossa region, superficially taping an IV catheter. |
|
| Chevron Taping Method | Device | Subjects will be asked to have the Chevron taping method placed on their left and right antecubital fossa region, superficially taping an IV catheter. |
|
| BG001 | 90 Degrees Directional Test | Subjects during the 90 Degrees Directional Test will have the three taping methods placed on their left and right antecubital fossa region, superficially taping an IV catheter (i.e., the catheter will be placed on top of the participant's skin and not in the vein but will be taped as if the catheter was placed intravenously). Six total measurements will be obtained of which three will be using the 90 Degrees Directional Test (i.e., each taping method will undergo testing for each directional method). The order of placing the different taping methods and the direction testing will be randomized. Novel Taping Method: Subjects will be asked to have the novel taping method placed on their left and right antecubital fossa region, superficially taping an IV catheter. BCH Emergency Department Taping Method: Subjects will be asked to have the BCH emergency department taping method placed on their left and right antecubital fossa region, superficially taping an IV catheter. Chevron Taping Method: Subjects will be asked to have the Chevron taping method placed on their left and right antecubital fossa region, superficially taping an IV catheter. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
| No |
|
| Sex: Female, Male | Numbers represent number of participants randomized to start with retrograde directional test or 90 degrees directional test. All participants cross-overed and therefore, were subjected to both tests regardless of randomization. | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | 2 participants were withdrawn due to equipment error. | Count of Participants | Participants | No |
|
| Acceptable Skin State | Individuals with fragile and/or non-intact skin were not included for recruitment | Count of Participants | Participants |
|
| OG002 | ED Taping | The ED taping method will be employed to measure the maximum force (Newtons) required to dislodge an IV catheter (without puncturing of skin) secured in the retrograde direction, distally from the insertion site. |
|
|
| Primary | The Force (Newtons) Required to Dislodge an IV Catheter Secured in a 90 Degrees Direction. | We will examine the maximum force the taping methods can withstand as measured by the force gauge in a 90 degrees direction, medially from the insertion site. | Numbers represent number of participants randomized to start with retrograde directional test or 90 degrees directional test. All participants cross-overed and therefore, were subjected to both tests regardless of randomization. | Posted | Mean | Standard Deviation | Newtons | Until the tape is dislodged- approximately 15 seconds |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Retrograde Directional Test: Chevron Taping | The Chevron taping method will be employed to measure the maximum force (Newtons) required to dislodge an IV catheter (without puncturing of skin) secured in the retrograde direction, distally from the insertion site. | 0 | 30 | 0 | 30 | 0 | 30 |
| EG002 | Retrograde Directional Test: ED Taping | The ED taping method will be employed to measure the maximum force (Newtons) required to dislodge an IV catheter (without puncturing of skin) secured in the retrograde direction, distally from the insertion site. | 0 | 30 | 0 | 30 | 0 | 30 |
| EG003 | 90 Degrees Directional Test: Novel Taping | The novel taping method will be employed to measure the maximum force (Newtons) required to dislodge an IV catheter (without puncturing of skin) secured in the 90-degrees direction, medially from the insertion site. | 0 | 30 | 0 | 30 | 0 | 30 |
| EG004 | 90 Degrees Directional Test: Chevron Taping | The Chevron taping method will be employed to measure the maximum force (Newtons) required to dislodge an IV catheter (without puncturing of skin) secured in the 90-degrees direction, medially from the insertion site. | 0 | 30 | 0 | 30 | 0 | 30 |
| EG005 | 90 Degrees Directional Test: ED Taping | The ED taping method will be employed to measure the maximum force (Newtons) required to dislodge an IV catheter (without puncturing of skin) secured in the 90-degrees direction, medially from the insertion site. | 0 | 30 | 0 | 30 | 0 | 30 |
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