Assessment of the Effectiveness and Ease of Use of DirectVision- a Direct Visualization System for Urinary Catheterization: Results of a Single Center Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Degree of Difficulty
研究概览
简要总结
The Center for Disease Control and Prevention (CDC) reports that one in four patients hospitalized in the United States is catheterized to void the bladder or monitor urinary output. In the male population, Dr. Singh, an urologist estimates that about 20% of catheterizations are difficult. Driving a catheter blindly, guessing whether to push the catheter forward or manipulate it to get around a point of resistance leads to the risk of injury which increases the more the catheter is manipulated. Additional adverse events include: urosepsis, UTI and bladder perforation. The standard of care treatment for patients with difficult urinary catheterization (DUC) is to proceed with a cystoscopic catheter placement or suprapubic tube placement.
PercuVision has the only Foley catheter with a micro-endoscope for visualization and navigation of the urethra for nurses and other qualified health care professionals. Moreover, it allows urologists to place a guidewire under direct vision rather than calling for a flexible cystoscope which is considered a minor procedure.
In this study, the investigators plan on assessing the effectiveness and ease of use of the PercuVision DirectVision® System device.
详细描述
Routine placement of transurethral catheters can be challenging in some situations, such as urethral strictures, severe phimosis and false passages. Intravaginal retraction of the urethral meatus can complicate Foley placement in postmenopausal females. In men, blind urethral procedures with mechanical or metal sounds without visual guidance or guidewire assistance are now discouraged due to the increased risk of urethral trauma and false passages.
DirectVision is a new visually-guided catheterization device (VGCD) that uses a camera visual guide / microendoscope within a triple lumen flexible urinary catheter with an angled tip, essentially combining the functionality of a urinary catheter with a cystoscope. DirectVision uses fiber-optic bundle of 6,000 integrated fibers to provide illumination and transmit real-time video.
Procedures done via flexible cystoscopy or DirectVision are covered by insurance (including Medicaid/Medicare).
In this prospective study, the investigators plan on assessing the effectiveness and ease of use of DirectVision - A direct visualization system for urinary catheterization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any patient over 18 years with a standard indication for difficult urinary catheterization
排除标准
- •Any patient younger than 18 years of age, pregnant patients
研究组 & 干预措施
Cystoscopy
will have catheter placement using the cystoscopy method
干预措施: Cystoscopy (Procedure)
DirectVision
will have catheter placement using DirectVision.
干预措施: DirectVision (Device)
结局指标
主要结局
Degree of Difficulty
时间窗: duration of procedure
Degree of difficulty defined as easy versus difficult
Procedure Findings
时间窗: duration of procedure
Procedure findings * 1- Obliterated urethra * 2-High bladder neck * 3-Normal urethra * 4-Urethral stricture * 5-Bladder neck contracture
Set up Time/Total Procedure Time to Place Catheter Via DirectVision/Cystoscope
时间窗: prep and duration of procedure, up to 1 hour
Duration to set up and complete the procedure either by DirectVision or Cystoscope was observed and calculated by minutes.
Effectiveness of DirectVision-adverse Events
时间窗: 7 months
assessment will be done by reviewing the number of Participants who had adverse events that are related to the procedures.
Ancillary Tools Used
时间窗: duration of procedure
Ancillary tools used wire, SPT, etc
Presence of Pain and Hematuria
时间窗: duration of procedure
To compare DirectVision to the cystoscope we compared if patients experienced pain or hematuria
次要结局
- Cost to Use Cystoscope Versus DirectVision(7 months)
研究者
Sijo J. Parekattil, M.D.
Director of PUR clinic, Investigator
The Pur Clinic