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創新呼吸器管路緊密度檢測工具與呼吸器自我緊密度檢測方式的可靠性比較

Reliability comparison between the innovative tightness detection instrument for ventilator circuits and ventilator self-tightness detection

摘要


為預防病人發生呼吸器相關肺炎 (ventilator-associated pneumonia, VAP),呼吸器管路需定期更換、清潔與消毒。管路與集水瓶經多次以及長時間的清潔、消毒、烘乾等流程,容易造成呼吸管路材質脆化、龜裂、破損,影響集水瓶密封效果而造成漏氣。本研究目的,在探討創新緊密度檢測工具與兩款可執行自我緊密度檢測呼吸器之差異性比較以及可靠性驗證。本研究於實驗室內進行測試,非為人體或動物試驗研究。研究步驟一為差異性比較,由創新檢測工具分別複測通過呼吸器A 和B 緊密度測試的100 條管路和50 個集水瓶。研究步驟二為可靠性驗證,由呼吸器A 和B 複測通過創新檢測工具緊密度測試的100 條管路和50 個集水瓶。研究結果包括:差異性比較結果發現通過呼吸器A 和B 的緊密度測試,仍有相當比例的呼吸管路和集水瓶被創新工具檢測出漏氣 (與呼吸器A 比較, p 值分別為0.0131 和0.0001; 與呼吸器B 比較, p值分別為0.0040 和<0.0001)。可靠性驗證結果發現,通過創新工具緊密度測試的呼吸管路和集水瓶,通過呼吸器A 和B 的緊密度測試的比例是100%。結論:本研究證實使用呼吸器A 和B內建的緊密度測試是無法確保呼吸器管路系統沒有漏氣。而通過創新工具測試的呼吸管路和集水瓶確實都能通過呼吸器A 和B 內建的緊密度測試,證實創新工具的可靠性。

並列摘要


In order to prevent ventilator-associated pneumonia (VAP), the ventilator circuits should be cleaned and disinfected regularly. After several times of cleaning, disinfection, drying and other processes, ventilator tubes and water traps likely have brittle cracks or damage in the ventilator tubes or the impairment of the sealing effect due to leakage of water traps. This study aimed to investigate the difference on the proportion of the leakage of ventilator tubing and water traps between the innovative tightness detection instrument and two executable self-tightness test ventilators for reliability comparison and validation. Experiment design was in-laboratory and based on non-human or animal subject research. The first step of this study is to make the comparison between 100 tubes and 50 water traps which was passed the ventilator A and B built-in tightness test by innovative testing instrument. Then the second step is retesting it by ventilator A and B again to verify the reliability of innovative instrument tightness test. The results showed that there is a part of tubes and water traps are leak-detected by the innovative instrument (versus A, p values were 0.0131 and 0.0001, respectively; versus B, p values were 0.0040 and <0.0001, respectively), even though they are passed from ventilator A and B built-intightness test. Reliability verification results revealed that the breathing tubes and water traps which passed the innovative instrument tightness test could certainly passed the ventilator A and B built-in tightness test. Therefore, the conclusion shows that it can’t totally prevent leakage from only built-in tightness test of ventilator A and B. However, with breathing tubes and water traps that passed the innovative instrument tightness test could sure passed thebuilt-in tightness test of ventilator A and B, which and confirm the reliability of this new tool.

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