Dislodged CatheterNCT05948878
An Innovative Taping Technique for Improved Intravenous (IV) Catheter Securement
A study testing Novel Taping Method, BCH Emergency Department Taping Method and Chevron Taping Method in people with Dislodged Catheter and Catheter Related Complication, run by Boston Children's Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dislodged Catheter, Catheter Related Complication
- What is being tested?
- Novel Taping Method, BCH Emergency Department Taping Method and Chevron Taping Method
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2023to 9 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Employees of Boston Children's Hospital
Who cannot join
- Individuals under the direct supervision of any study investigators
- Individuals with excessive hair in/near the antecubital fossa region on either arm
- Individuals with fragile and/or non-intact skin in/near the antecubital fossa region
- Individuals who have adhesive allergies
- Individuals who have already participated
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
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).
Read the detailed description
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.
- Conditions
- Dislodged Catheter, Catheter Related Complication
- Being tested
- Novel Taping Method, BCH Emergency Department Taping Method, Chevron Taping Method
- Keywords
- Catheter Taping Methods, Catheter securement, Catheters, Intravenous catheters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel Taping MethodDevice
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 MethodDevice
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 MethodDevice
Subjects will be asked to have the Chevron taping method placed on their left and right antecubital fossa region, superficially taping an IV catheter.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Novel Taping Method; Device: BCH Emergency Department Taping Method; Device: Chevron Taping Method |
| 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. Receives: Device: Novel Taping Method; Device: BCH Emergency Department Taping Method; Device: Chevron Taping Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Until the tape is dislodged- approximately 15 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start28 Jul 2023
- Primary completion9 Nov 2023
- Study completion9 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dislodged CatheterStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pete Kovatsis, Boston Children's Hospital
- Investigators
- Pete Kovatsis, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948878
- Sponsor's protocol ID
- IRB-P00043126
- Status last verified
- Mar 2026
- First submitted
- 28 Nov 2022
- Last updated
- 15 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Innovative Taping Technique for Improved Intravenous (IV) Catheter Securement
- ClinicalTrials.gov ID
- NCT05948878
- Acronym / sponsor ID
- IRB-P00043126
- Conditions
- Dislodged Catheter, Catheter Related Complication
- Keywords
- Catheter Taping Methods, Catheter securement, Catheters, Intravenous catheters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 28 Jul 2023 (actual)
- Primary completion
- 9 Nov 2023 (actual)
- Study completion
- 9 Nov 2023 (actual)
- First posted
- 17 Jul 2023 (actual)
- Results
- Posted 15 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrograde Directional Test | Active comparator | Device: Novel Taping Method, Device: BCH Emergency Department Taping Method, Device: Chevron Taping MethodSubjects 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. |
| 90 Degrees Directional Test | Active comparator | Device: Novel Taping Method, Device: BCH Emergency Department Taping Method, Device: Chevron Taping MethodSubjects 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Employees of Boston Children's Hospital
Key exclusion criteria (5 listed)
- Individuals under the direct supervision of any study investigators
- Individuals with excessive hair in/near the antecubital fossa region on either arm
- Individuals with fragile and/or non-intact skin in/near the antecubital fossa region
- Individuals who have adhesive allergies
- Individuals who have already participated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel Taping MethodSubjects will be asked to have the novel taping method placed on their left and right antecubital fossa region, superficially taping an IV catheter. | Device | 90 Degrees Directional Test, Retrograde Directional Test |
| BCH Emergency Department Taping MethodSubjects 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. | Device | 90 Degrees Directional Test, Retrograde Directional Test |
| Chevron Taping MethodSubjects will be asked to have the Chevron taping method placed on their left and right antecubital fossa region, superficially taping an IV catheter. | Device | 90 Degrees Directional Test, Retrograde Directional Test |
Primary outcome
The Force (Newtons) Required to Dislodge an IV Catheter Secured in the Retrograde Direction.
Time frame: Until the tape is dislodged- approximately 15 seconds
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.
The Force (Newtons) Required to Dislodge an IV Catheter Secured in a 90 Degrees Direction.
Time frame: Until the tape is dislodged- approximately 15 seconds
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pete Kovatsis, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel Taping Method, BCH Emergency Department Taping Method and Chevron Taping Method in people with Dislodged Catheter and Catheter Related Complication, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Force (Newtons) Required to Dislodge an IV Catheter Secured in the Retrograde Direction. (time frame: Until the tape is dislodged- approximately 15 seconds). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.