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Clinical Evaluation of a Safety-device to Prevent Urinary Catheter Inflation Related Injuries

机译：一种安全装置的临床评价，防止尿道导管通胀相关损伤

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ObjectiveTo evaluate the feasibility of a novel “safety-valve” device for preventing catheter related urethral trauma during urethral catheterization (UC). To assess the opinions of clinicians on the performance of the safety-valve device. Materials and MethodsA validated prototype “safety-valve” device for preventing catheter balloon inflation related urethral injuries was prospectively piloted in male patients requiring UC in a tertiary referral teaching hospital (n?=?100). The device allows fluid in the catheter system to decant through an activated safety threshold pressure valve if the catheter anchoring balloon is misplaced. Users evaluated the “safety-valve” with an anonymous questionnaire. The primary outcome measurement was prevention of anchoring balloon inflation in the urethra. Secondary outcome measurement was successful inflation of urinary catheter anchoring balloon in the bladder. ResultsPatient age was 76?±?12 years and American Society of Anaesthesiologists grade was 3?±?1.4. The “safety-valve” was utilized by 34 clinicians and activated in 7% (n?=?7/100) patients during attempted UC, indicating that the catheter anchoring balloon was incorrectly positioned in the patient's urethra. In these 7 cases, the catheter was successfully manipulated into the urinary bladder and inflated. 31 of 34 (91%) clinicians completed the questionnaire. Ten percent (n?=?3/31) of respondents had previously inflated a urinary catheter anchoring balloon in the urethra and 100% (n?=?31) felt that a safety mechanism for preventing balloon inflation in the urethra should be compulsory for all UCs. ConclusionThe safety-valve device piloted in this clinical study offers an effective solution for preventing catheter balloon inflation related urethral injuries.
机译：ObjectiveTo评估了一种新型“安全阀”装置，用于防止导管相关尿道创伤在尿道导管（UC）中的可行性。评估临床医生对安全阀装置性能的意见。用于预防导管球囊通胀相关尿道损伤的材料和方法验证的原型“安全阀”装置在第三节推荐医院中需要UC的男性患者前瞻性地试行（N？=？100）。如果导管锚固球囊被放置，则该装置允许导管系统中的流体倾覆通过激活的安全阈值压力阀。用户使用匿名问卷评估“安全阀”。主要结果测量是预防尿道中的锚固球囊膨胀。二次结果测量是膀胱中尿道导管锚定球囊的成功膨胀。结果为76岁？±12岁和美国麻醉学家等级为3？±1.4。 “安全阀”在34名临床医生中使用，并在尝试的UC期间以7％（n？= 7/100）患者激活，表明导管锚固气囊在患者的尿道中被错误地定位。在这7例中，将导管成功操纵到尿膀胱并充气。 31个共31个（91％）临床医生完成了调查问卷。受访者的百分之十（n？= 3/31）先前夸大了尿道中的尿道导管锚球气囊，100％（n？=？31）认为，用于预防尿道中的气球通胀的安全机制应该​​是强制性的所有UCS。结论该临床研究中驾驶的安全阀装置提供了防止导管球囊通胀相关尿道损伤的有效解决方案。

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  • 来源
    《Urology》 |2018年第2018期|共5页
  • 作者

    Niall F. Davis; Eoghan M. Cunnane; Rory OC Mooney; James C. Forde; Michael T. Walsh;

  • 作者单位

    Department of Urology and Transplant Surgery Beaumont Hospital;

    Centre for Applied Biomedical Engineering Research School of Engineering Bernal Institute and the;

    Centre for Applied Biomedical Engineering Research School of Engineering Bernal Institute and the;

    Department of Urology and Transplant Surgery Beaumont Hospital;

    Centre for Applied Biomedical Engineering Research School of Engineering Bernal Institute and the;

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  • 正文语种 eng
  • 中图分类 泌尿科学（泌尿生殖系疾病）;
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