A Multicenter Evaluation of a Closed-Loop Anesthesia Delivery System: A Randomized Controlled Trial
| Autor: | Satinder Gombar, Jayashree Sood, Aveek Jayant, Amitabh Dutta, P. L. Gautam, Goverdhan Dutt Puri, T. S. Punia, Inderjeet Arora, Morup Tsering, Sanjeev Palta, Preethy J Mathew, Gurjit Singh, Indranil Biswas, Vishal Bajaj |
|---|---|
| Rok vydání: | 2015 |
| Předmět: |
Adult
Male Time Factors Consciousness Intraoperative Neurophysiological Monitoring Operative Time India Clinical settings Anesthesia General Drug Administration Schedule law.invention 03 medical and health sciences Automation 0302 clinical medicine Consciousness Monitors Drug Delivery Systems Randomized controlled trial 030202 anesthesiology law Heart Rate Predictive Value of Tests Medicine Humans Arterial Pressure Single-Blind Method Infusions Intravenous Propofol business.industry 030208 emergency & critical care medicine Equipment Design Middle Aged Anesthesiology and Pain Medicine Treatment Outcome Multicenter study Bispectral index Anesthesia Anesthesia Intravenous Operative time Feasibility Studies Female Delivery system business Closed loop Anesthetics Intravenous medicine.drug |
| Zdroj: | Anesthesia and analgesia. 122(1) |
| ISSN: | 1526-7598 |
| Popis: | Closed-loop systems for anesthesia delivery have been shown to outperform traditional manual control in different clinical settings. The present trial was aimed at evaluating the feasibility and efficacy of Bispectral Index (BIS)-guided closed-loop anesthesia delivery system (CLADS) in comparison with manual control across multiple centers in India.Adult patients scheduled for major surgical procedures of an expected duration of 1 to 3 hours were randomized across 6 sites into 2 groups: a CLADS group and a manual group. In the manual control group, propofol infusion was titrated manually by the attending anesthesiologist to a BIS of 50 during induction and maintenance. Analgesia was maintained with fentanyl infusion and nitrous oxide in both groups. In the CLADS group, both induction and maintenance of anesthesia were performed automatically using CLADS. The primary outcome measure was the performance of the system as assessed by the percentage of total anesthesia time BIS remained ±10 of target BIS. The secondary outcome measures were a percentage of anesthesia-time heart rate and mean arterial pressure within 25% of the baseline, median absolute performance error, wobble, and global score. Wobble indicates intraindividual variability in the control of BIS, and global score reflects the overall performance; lower values indicate superior performance for both parameters. The performance parameters of the system also were compared among the participating sites.Two hundred forty-two patients were randomized. BIS was maintained within ±10 of target for significantly longer time in the CLADS group (81.4% ± 8.9 % of anesthesia duration) than in the manual group (55.34% ± 25%, P0.0001). The indices that assess performance were significantly better in the CLADS group than the manual group as follows: median absolute performance error was 10 (10, 12) (median [interquartile range]) in the CLADS group versus 18 (14, 24) in the manual group, P0.0001; wobble was 9 (8, 10) in CLADS group versus 10 (8, 14) in the manual group, P = 0.0009; and Global score, which reflects overall performance, was 24 (19, 30) in the CLADS group versus 51 (31, 99) in the manual group, P0.0001. The percentage of time heart rate was within 25% of the baseline was significantly greater in the CLADS group (heart rate of 95 [87, 99], median [interquartile range], in the CLADS group versus 90 [75, 98] in the manual group P = 0.0031). On comparison of data between the centers, the performance parameters did not differ significantly among the centers in the CLADS group (P = 0.94), but the parameters differed significantly among the centers in the manual group (P0.001).Our study in a multicenter setting proves the consistently better performance of automated anesthesia drug delivery compared with conventional manual control. This highlights an important advantage of an automated system for delivering standardized anesthesia, thereby overcoming differences in practices among anesthesiologists. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|