An Innovative Taping Technique for Improved Intravenous (IV) Catheter Securement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- The Force (Newtons) Required to Dislodge an IV Catheter Secured by the Chevron, BCH ED, and Novel Taping Methods Using a Force Gauge in the retrograde direction.
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Employees of Boston Children's Hospital
排除标准
- •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
研究组 & 干预措施
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.
干预措施: BCH Emergency Department Taping Method (Device)
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.
干预措施: Novel Taping Method (Device)
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.
干预措施: BCH Emergency Department Taping Method (Device)
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.
干预措施: Chevron Taping Method (Device)
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.
干预措施: Novel Taping Method (Device)
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.
干预措施: Chevron Taping Method (Device)
结局指标
主要结局
The Force (Newtons) Required to Dislodge an IV Catheter Secured by the Chevron, BCH ED, and Novel Taping Methods Using a Force Gauge in the retrograde direction.
时间窗: Until the tape is dislodged- approximately 15 seconds
We will examine the maximum force the Chevron, BCH ED, and Novel 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 by the Chevron, BCH ED, and Novel Taping Methods Using a Force Gauge in a 90 degrees direction.
时间窗: Until the tape is dislodged- approximately 15 seconds
We will examine the maximum force the Chevron, BCH ED, and Novel taping methods can withstand as measured by the force gauge in a 90 degrees direction, medially from the insertion site.
The Force (Newtons) Required to Dislodge an IV Catheter Secured in the Retrograde Direction.
时间窗: 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.
时间窗: 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.
次要结局
未报告次要终点
研究者
Pete Kovatsis
Principle Investigator
Boston Children's Hospital