導尿管固定裝置的創新研發與實證

The Innovative Study and Validation of the Urine Catheter Fixation Device

背景：長期留置導尿管易造成病人感染、滑脫、和皮膚受損等問題，感染嚴重可能導致敗血症，甚至死亡，目前臨床固定留置尿管方式主要以3M紙膠，或透氣膠帶黏貼固定為主，但移除紙膠時，除了會造成病人不適感，也會因移除紙膠而造成管路不當的拉扯，而增加感染問題。目的：本研究目的乃研發一個創新導尿管的固定裝置，並驗證其成效。方法：研究團隊依據文獻所提導尿管固定裝置的確實固定性、最少管路接觸面、避免壓迫病人的皮膚，及舒適度等指標，作為設計本創新導尿管固定裝置的依據，再邀請三位護理專家，依據安全性、可行性、實用性等指標，以1-5評分進行審查；此外，自2019年5至7月間，研究團隊針對85位護理人員和85位病人，調查原3M固定和創新導尿管固定裝置使用後的滿意度及成效。結果：三位護理專家於創新導尿管固定裝置的安全性、可行性、及實用性審查高達4.7分，接近非常滿意程度。此外，85位護理人員表示創新固定方式滿意度4.51，而原3M固定滿意度僅1.85，達顯著差異（p<.05）。再者，91.8%潛在皮膚完整性受損的病人（N=78），於改用創新導尿管固定裝置後，病人潛在皮膚完整性的受損率降至0%，亦達顯著差異（p<.05）。最後，78位病人對採用創新導尿管固定裝置後的舒適滿意度4.39，但原3M固定滿意度僅1.89，又達顯著差異（p<.05）。結論：透過創新導尿管固定裝置的研發，加上專家審查、原案和新案的測試、市場的分析、護理人員和病人使用的滿意度調查，及病人使用後之成效等結果，都已證實創新導尿管固定裝置的成效，故此創新產品值得被開發和推廣。

Background: Long-term indwelling catheters can easily cause problems such as infection, slippage, and skin damage that severe infections may lead to sepsis and even death. Currently the clinical fixation of indwelling catheters is mainly based on 3M paper or breathable tape. When removing the paper, it not only makes discomfort to the patient, but it also leads improper pulling of the pipeline due to the removal of the paper, which will increase the infection problem. Objective: The purpose of this study was to study the innovative urinary catheter fixation device and validate its effectiveness. Method: Research team designed the innovative urinary catheter fixation device by following the literature indicators including the accurate fixation, least touching surface of the tube, avoid pressuring the patients’ skin, and comfort about the urinary catheter. The innovative urinary catheter fixation device was reviewed by three nursing experts with a score of 1-5 by the indicators of the safety, feasibility, and practicality; additionally, from May to July 2019, the research team investigated the use of the original 3M fixation and the innovative catheter fixation device among 85 nurses and 85 patients regarding to their satisfactions and outcomes. Result: Three nursing experts reviewed the innovative urinary catheter fixation device by the safety, feasibility, and practicality approaching at 4.7 highly score which is close to very satisfied level. Additionally, 85 nursing staffs reported the satisfaction about the way of innovative fixation was 4.51, while the satisfaction of the original 3M fixation was 1.85, that has achieved in the significant difference (p<.05). Furthermore, 91.8% patients with potential skin integrity impaired (N=78) and the rate was reduced to 0% after switching to the innovative urinary catheter fixation device that has also achieved in the significant difference (p<.05). Finally, 78 patients responded the comfort satisfaction was 4.39 after using the innovative urinary catheter fixation device, but the satisfaction for the original 3M fixation was 1.89 that has again achieved in the significant difference (p<.05). Conclusion: Through studying the innovative urinary catheter fixation device, the outcomes included the experts’ review, testing of original and new products, market analysis, surveys of satisfaction from the nursing staffs and patients, and patients’ effectiveness after using the innovative product that all have validated the effectiveness of the innovative urinary catheter fixation device; therefore, this innovative product is worthful to be developed and promoted.