Catheter Related Complication, Dislodged Catheter
Conditions
Keywords
Catheter Taping Methods, Catheter securement, Catheters, Intravenous catheters
Brief 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. 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.
Interventions
DEVICENovel 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.
DEVICEBCH 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.
DEVICEChevron 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.
Sponsors
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Employees of Boston Children's Hospital
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Force (Newtons) Required to Dislodge an IV Catheter Secured in the Retrograde Direction. | 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. | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPete Kovatsis, MD
Boston Children's Hospital
Baseline characteristics
| Characteristic | — |
|---|---|
| Acceptable Skin State | 14 Participants |
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment United States | 16 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 |
Outcome results
None listed