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Closed-loop control better than open-loop control of profofol TCI guided by BIS: a randomized, controlled, multicenter clinical trial to evaluate the CONCERT-CL closed-loop system.

Liu Y, Li M, Yang D, Zhang X, Wu A, Yao S, Xue Z, Yue Y - PLoS ONE (2015)

Bottom Line: GS in the closed-loop groups (22.21±8.50) were lower than that in the opened-loop group (27.19±15.26) (p=0.009).No significant differences in propofol dose and time of tracheal extubation were observed.ChiCTR ChiCTR-OOR-14005551.

View Article: PubMed Central - PubMed

Affiliation: Department of Anesthesiology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, People's Republic of China.

ABSTRACT

Background: The CONCERT-CL closed-loop infusion system designed by VERYARK Technology Co., Ltd. (Guangxi, China) is an innovation using TCI combined with closed-loop controlled intravenous anesthesia under the guide of BIS. In this study we performed a randomized, controlled, multicenter study to compare closed-loop control and open-loop control of propofol by using the CONCERT-CL closed-loop infusion system.

Methods: 180 surgical patients from three medical centers undergone TCI intravenous anesthesia with propofol and remifentanil were randomly assigned to propofol closed-loop group and propofol opened-loop groups. Primary outcome was global score (GS, GS = (MDAPE+Wobble)/% of time of bispectral index (BIS) 40-60). Secondary outcomes were doses of the anesthetics and emergence time from anesthesia, such as, time to tracheal extubation.

Results: There were 89 and 86 patients in the closed-loop and opened-loop groups, respectively. GS in the closed-loop groups (22.21±8.50) were lower than that in the opened-loop group (27.19±15.26) (p=0.009). The higher proportion of time of BIS between 40 and 60 was also observed in the closed-loop group (84.11±9.50%), while that was 79.92±13.17% in the opened-loop group, (p=0.016). No significant differences in propofol dose and time of tracheal extubation were observed. The frequency of propofol regulation in the closed-loop group (31.55±9.46 times/hr) was obverse higher than that in the opened-loop group (6.84±6.21 times/hr) (p=0.000).

Conclusion: The CONCERT-CL closed-loop infusion system can automatically regulate the TCI of propofol, maintain the BIS value in an adequate range and reduce the workload of anesthesiologists better than open-loop system.

Trial registration: ChiCTR ChiCTR-OOR-14005551.

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Patients’ flowchart.Of the 180 included patients, 1 and 3 patients were excluded from the closed-loop and opened-loop group, respectively, due to artifact of BIS, too short maintenance duration, or operation error. Thus, 89 and 86 patients were available for analysis in the two groups, respectively.
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pone.0123862.g001: Patients’ flowchart.Of the 180 included patients, 1 and 3 patients were excluded from the closed-loop and opened-loop group, respectively, due to artifact of BIS, too short maintenance duration, or operation error. Thus, 89 and 86 patients were available for analysis in the two groups, respectively.

Mentions: From 2012-12-13 to 2013-6-13 we had recruited 180 patients into the trial. Of the 180 included patients, 1 and 3 patients were excluded from the closed-loop group and opened-loop group, respectively, due to artifact of BIS, too short maintenance duration, or operation error (Fig 1). Thus, 89 and 86 patients were available for analysis in the two groups, respectively.


Closed-loop control better than open-loop control of profofol TCI guided by BIS: a randomized, controlled, multicenter clinical trial to evaluate the CONCERT-CL closed-loop system.

Liu Y, Li M, Yang D, Zhang X, Wu A, Yao S, Xue Z, Yue Y - PLoS ONE (2015)

Patients’ flowchart.Of the 180 included patients, 1 and 3 patients were excluded from the closed-loop and opened-loop group, respectively, due to artifact of BIS, too short maintenance duration, or operation error. Thus, 89 and 86 patients were available for analysis in the two groups, respectively.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4401751&req=5

pone.0123862.g001: Patients’ flowchart.Of the 180 included patients, 1 and 3 patients were excluded from the closed-loop and opened-loop group, respectively, due to artifact of BIS, too short maintenance duration, or operation error. Thus, 89 and 86 patients were available for analysis in the two groups, respectively.
Mentions: From 2012-12-13 to 2013-6-13 we had recruited 180 patients into the trial. Of the 180 included patients, 1 and 3 patients were excluded from the closed-loop group and opened-loop group, respectively, due to artifact of BIS, too short maintenance duration, or operation error (Fig 1). Thus, 89 and 86 patients were available for analysis in the two groups, respectively.

Bottom Line: GS in the closed-loop groups (22.21±8.50) were lower than that in the opened-loop group (27.19±15.26) (p=0.009).No significant differences in propofol dose and time of tracheal extubation were observed.ChiCTR ChiCTR-OOR-14005551.

View Article: PubMed Central - PubMed

Affiliation: Department of Anesthesiology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, People's Republic of China.

ABSTRACT

Background: The CONCERT-CL closed-loop infusion system designed by VERYARK Technology Co., Ltd. (Guangxi, China) is an innovation using TCI combined with closed-loop controlled intravenous anesthesia under the guide of BIS. In this study we performed a randomized, controlled, multicenter study to compare closed-loop control and open-loop control of propofol by using the CONCERT-CL closed-loop infusion system.

Methods: 180 surgical patients from three medical centers undergone TCI intravenous anesthesia with propofol and remifentanil were randomly assigned to propofol closed-loop group and propofol opened-loop groups. Primary outcome was global score (GS, GS = (MDAPE+Wobble)/% of time of bispectral index (BIS) 40-60). Secondary outcomes were doses of the anesthetics and emergence time from anesthesia, such as, time to tracheal extubation.

Results: There were 89 and 86 patients in the closed-loop and opened-loop groups, respectively. GS in the closed-loop groups (22.21±8.50) were lower than that in the opened-loop group (27.19±15.26) (p=0.009). The higher proportion of time of BIS between 40 and 60 was also observed in the closed-loop group (84.11±9.50%), while that was 79.92±13.17% in the opened-loop group, (p=0.016). No significant differences in propofol dose and time of tracheal extubation were observed. The frequency of propofol regulation in the closed-loop group (31.55±9.46 times/hr) was obverse higher than that in the opened-loop group (6.84±6.21 times/hr) (p=0.000).

Conclusion: The CONCERT-CL closed-loop infusion system can automatically regulate the TCI of propofol, maintain the BIS value in an adequate range and reduce the workload of anesthesiologists better than open-loop system.

Trial registration: ChiCTR ChiCTR-OOR-14005551.

Show MeSH
Related in: MedlinePlus