| Objective:This study aims to compare the superiority of subcutaneous tunneling technology in improving PICC dwelling,and further optimizing the tunneled PICC based on the Zone Insertion MethodTM(ZIMTM),which will further contribute to reducing catheter-related complications,enhancing patient comfort,and encouraging the use of subcutaneous tunneling technology for PICC placement.Method:The first part:From July 2021 to December 2021,a prospective,multicenter,randomized controlled trial was conducted in which all eligible subjects were 1:1 randomized into either the experimental group(with tunneled PICC)or the control group(with non-tunneled PICC).We collected data during placement,24 hours after catheter placement,7±3 days later,and every 30±7 days during the indwelling period,as well as after the catheter was removed when the patients returned to the hospital or during telephone or WeChat follow-up.The primary outcome was the incidence of catheter-related complications,and the secondary outcomes included the amount of bleeding after 24 hours,self-reported pain,self-reported comfort,one-time total catheter placement success rate,the incidence of unplanned extubation,the incidence of difficult extubation,catheter insertion time and catheter duration time.A variety of statistical analysis methods are available,including descriptive statistics,independent sample t-tests,Mann-Whitney U tests,chisquare tests,log-rank tests,and multivariate Cox regressions.The second part:Patients with a tunneled PICC were divided into three subgroups based on the ZIMTM principle,namely the green-red group,the green-green group,and the yellow-green group.Based on the first part’s results,we further explored the effect of different catheterization areas on the main superiority outcome after tunneled PICC catheterization.Statistical analysis methods include descriptive analysis,(corrected)ANOVA test,chi-square test,univariate Cox regression,and(corrected)multivariate Cox regression.Results:The first part:from July 2021 to December 2021,a total of 775 patients with PICC were included in this study.A total of 23 patients dropped out during follow-up,resulting in a drop-out rate of 2.97%.(1)Primary outcome:The incidence of PICC-related complications in the experimental group was 26.9%,while the incidence of PICC-related complications in the control group was 35.6%,with a statistically significant difference(P<0.05).Further analysis indicated that subcutaneous tunneling was effective in reducing catheter-related thrombosis(CRT)and catheter-related infection(CRI)(P<0.05).However,it was ineffective in reducing hematomas,nerve injuries,subcutaneous congestion,puncture site exudate,medical adhesive-related skin injuries(MARSI),catheter malposition,phlebitis,catheter injuries,and catheter blockages(P>0.05).(2)Secondary outcome:①A subcutaneous tunnel can effectively reduce the amount of 24 hours oozing blood at the exit site and improve the comfort of the arm on the side where the PICC is placed(P<0.05).②The effect of the subcutaneous tunnel technique on the onetime catheter placement success rate was not significant(P>0.05),but there was a statistical difference in the success rate of one-time puncture between the two groups(P<0.05).③It takes an additional 5 minutes to create a subcutaneous tunnel(P<0.05).There was no statistical difference between the two groups in self-pain score,the incidence of unplanned extubation,the incidence of difficult extubation,and catheter duration time(P>0.05).(3)Time change descriptive analysis:①Complication rates in both groups showed three stages after catheterization:a short peak period,a low plateau period,and a long peak period.②The exposed length of the catheter increased with time after catheterization in both groups,but the increase was more obvious in the control group.(4)Multivariate Cox regression analysis:①Group,history of thrombus,history of catheterization,D-dimer,catheter to vein ratio(C/V),and frequency of physical exercise were related to the occurrence of CRT(P<0.05).②The group,history of diabetes,white blood cell count(WBC),and the insertion arm were associated with the occurrence of CRI(P<0.05).In the second part:a total of 374 patients with tunneled PICCs were included,including the green-red group(n=114),green-green group(n=131),and yellow-green group(n=129).(1)CRT regression analysis results:In comparison with the green-red group,the green-green group showed no significant statistical difference in reducing the incidence of CRT(P>0.05);The yellow-green group had a statistically significant difference in reducing CRT(P<0.05).(2)CRI regression analysis results:In comparison with the green-red group,the greengreen group and yellow-green group showed no significant statistical difference in reducing the incidence of CRI(P>0.05).Conclusion:(1)After PICC placement,catheter-related complications occurred at a relatively high rate,and with time,they showed a pattern of "more at both ends and less in the middle".(2)In comparison to non-tunneled PICC,the tunneled PICC reduced catheter-related complications,particularly CRT and CRI,reduce 24-hour blood oozing and improve the success rate of one-time punctures.(3)For patients with a high risk of CRT who have a history of thrombus and catheterization,D-dimer≥0.5mg/L,C/V≥ 45%,and lower frequency of physical exercise,as well as patients with a high risk of CRI who have a history of diabetes,abnormal WBC,and the insertion arm is the left upper limb,they are the key promotion population of the tunneled PICC.(4)According to the ZIMTM theory,puncture from the yellow area and exit from the green area is the most ideal placement approach for tunneled PICC;however,to protect patients’ rights to achieve maximum comfort and safety,prospective,large-sample randomized controlled studies are still required in the future. |
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