Davis Niall F, Cunnane Eoghan M, Mooney Rory O'C, Forde James C, Walsh Michael T
Department of Urology and Transplant Surgery, Beaumont Hospital, Dublin, Ireland.
Centre for Applied Biomedical Engineering Research, School of Engineering, Bernal Institute and the Health Research Institute, University of Limerick, Limerick, Ireland.
Urology. 2018 May;115:179-183. doi: 10.1016/j.urology.2018.02.026. Epub 2018 Mar 1.
To 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.
A 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.
Patient 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.
The safety-valve device piloted in this clinical study offers an effective solution for preventing catheter balloon inflation related urethral injuries.
评估一种新型“安全阀”装置在尿道插管（UC）过程中预防导管相关尿道创伤的可行性。评估临床医生对安全阀装置性能的看法。
在一家三级转诊教学医院，对100例需要进行UC的男性患者前瞻性试用一种经验证的预防导管球囊充气相关尿道损伤的“安全阀”装置原型。如果导管固定球囊位置不当，该装置可使导管系统中的液体通过激活的安全阈值压力阀排出。使用者通过匿名问卷对“安全阀”进行评估。主要观察指标是预防尿道内固定球囊充气。次要观察指标是导尿管固定球囊在膀胱内成功充气。
患者年龄为76±12岁，美国麻醉医师协会分级为3±1.4。34名临床医生使用了“安全阀”，在尝试UC期间，7%（n = 7/100）的患者激活了该装置，表明导管固定球囊在患者尿道中位置不正确。在这7例中，导管成功插入膀胱并充气。34名临床医生中有31名（91%）完成了问卷。10%（n = 3/31）的受访者曾在尿道中给导尿管固定球囊充气，100%（n = 31）的受访者认为预防尿道球囊充气的安全机制对所有UC都应是强制性的。
本临床研究中试用的安全阀装置为预防导管球囊充气相关尿道损伤提供了一种有效解决方案。
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