Iwamoto Reiko, Kanou Seiya, Nakatani Eiji, Masuda Yoshiaki, Sano Rina, Asaki Motohiro, Matsunaga Mika
Department of Nursing, Fujieda Municipal General Hospital, Fujieda, JPN.
Department of Emergency Medicine and Critical Care Center, Fujieda Municipal General Hospital, Fujieda, JPN.
Cureus. 2024 Dec 4;16(12):e75082. doi: 10.7759/cureus.75082. eCollection 2024 Dec.
This study aimed to verify that the modified quick change (mQC) method of syringe exchange in critically ill patients receiving a continuous intravenous norepinephrine infusion is not inferior to the conventional double pumping (DP) method.
This non-blinded, quasi-randomized, non-inferiority trial was conducted in a single hospital from August 1, 2023 to February 29, 2024. Adult patients aged 18 years or older who were admitted to the emergency ward and received a continuous intravenous norepinephrine infusion were eligible for inclusion. This study utilized a convenience sample of all eligible patients admitted during the study period. Patients were allocated to the mQC group or the DP group based on their month of admission. The primary endpoint was defined as the difference between the minimum mean arterial pressure during the 10 minutes after norepinephrine exchange and the mean arterial pressure before exchange. Non-inferiority was established if the lower limit of the 95% confidence interval was within the prespecified margin of 10 mm Hg.
Thirteen patients in the mQC group and eight in the DP group were analyzed. The mean value of the primary endpoint was -8.92 mm Hg in the mQC group and -10.63 mm Hg in the DP group. The 95% confidence interval for the difference between the two groups ranged from 0 mm Hg to 8.50 mm Hg, which was within the prespecified margin. Therefore, the non-inferiority of the mQC method was confirmed.
The mQC method of syringe exchange was not inferior to the DP method in critically ill patients receiving a continuous intravenous norepinephrine infusion. Given its comparable safety profile and simpler procedure, the mQC method has the potential to become a standard exchange technique. However, future large-scale randomized controlled trials are required to verify our findings.
本研究旨在验证在接受持续静脉注射去甲肾上腺素的重症患者中，改良快速更换（mQC）注射器的方法不劣于传统的双泵（DP）方法。
本非盲、准随机、非劣效性试验于2023年8月1日至2024年2月29日在一家医院进行。年龄在18岁及以上、入住急诊病房并接受持续静脉注射去甲肾上腺素的成年患者符合纳入标准。本研究采用了研究期间所有符合条件患者的便利样本。根据患者的入院月份将其分配至mQC组或DP组。主要终点定义为去甲肾上腺素更换后10分钟内的最低平均动脉压与更换前平均动脉压之间的差值。如果95%置信区间的下限在预先设定的10 mmHg范围内，则认为具有非劣效性。
分析了mQC组的13例患者和DP组的8例患者。mQC组主要终点的平均值为-8.92 mmHg，DP组为-10.63 mmHg。两组差异的95%置信区间为0 mmHg至8.50 mmHg，在预先设定的范围内。因此，证实了mQC方法的非劣效性。
在接受持续静脉注射去甲肾上腺素的重症患者中，mQC注射器更换方法不劣于DP方法。鉴于其相当的安全性和更简单的操作程序，mQC方法有可能成为标准的更换技术。然而，未来需要进行大规模随机对照试验来验证我们的研究结果。
