A Pilot Study Examining the Effect of a Novel Cannulation Knife on User Satisfaction and Common Central Venous Catheter Insertion Complications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- User satisfaction with the new cannulation knife for CVC insertion.
研究概览
简要总结
The purpose of this study is to assess user satisfaction and the frequency of common central venous catheter insertion complications when using a novel cannulation knife.
详细描述
The primary objective is to assess user satisfaction with a new cannulation knife for central venous catheter (CVC) insertion. Secondary objectives include assessing the frequency of skin incision revisions, frequency of procedures being aborted and restarted, frequency of reverting to the use of the scalpel customarily used to make the incision, frequency of bleeding around the catheter after completion of the procedure, assessment of time to final catheter placement, and the frequency of central line-associated bloodstream infections (CLABSI).
The cannulation knife will be studied in three clinical areas:
- Cardiovascular Operating Room
- Cardiovascular Surgical Intensive Care Unit
- Interventional Cardiology
A prospective cohort of 24 clinicians will be enrolled. Each clinician will be asked to perform a total of five observed cannulations, resulting in a combined 120 observed procedures.
In cases where both the clinician and patient are amenable, a video recording will be taken of the procedure to document the study variables of interest (duration of the procedure, need for revisions, the incidence of bleeding, size of the final incision, etc.) and allow for later review.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient requires a 5 French, 7 French, or 12-14 French central venous catheter.
- •Operator responsible for insertion of central venous catheter.
排除标准
- •Patient unwilling to consent.
- •Operator unwilling to complete the survey.
结局指标
主要结局
User satisfaction with the new cannulation knife for CVC insertion.
时间窗: Within one (1) hour post-procedure
Using a survey developed by the study team, Operators will rate the performance of the cannulation knife in regards to the ease of skin incision, ease of dilator insertion, device safety, and opinion on usage for central venous line (CVL) placement with ongoing cardiopulmonary resuscitation (CPR), using a Likert Scale (scores range from 1: significant benefit to 5: significant hindrance). The possible overall score ranges from four (4) to twenty (20), with a higher score indicating user dissatisfaction and hindrance.
次要结局
- Frequency of skin incision revisions.(Within one (1) hour post-procedure)
- Frequency of reverting to use of the scalpel normally used to make the incision.(Within one (1) hour post-procedure)
- Presence of a clean, dry dressing.(Within thirty-six hours (36) post-procedure)
- Frequency of procedures being aborted and restarted.(Within one (1) hour post-procedure)