title: Closed-Loop Feedback Computer-Controlled Phenylephrine for Maintenance of Blood Pressure During Spinal Anesthesia for Cesarean Delivery: A Randomized Trial Comparing Automated Boluses Versus Infusion.
abstract: We previously described the use of closed-loop feedback computer-controlled infusion of phenylephrine for maintaining blood pressure (BP) during spinal anesthesia for cesarean delivery. In this study, we report a modified system in which phenylephrine is delivered by intermittent boluses rather than infusion. We hypothesized that the use of computer-controlled boluses would result in more precise control of BP compared with infusions.
  
  
  
  Two hundred fourteen healthy patients having spinal anesthesia for elective cesarean delivery were randomized to have their systolic BP maintained by phenylephrine administered by computer-controlled continuous infusion or computer-controlled intermittent boluses. From induction of anesthesia until the time of uterine incision, a noninvasive BP monitor was set to cycle at 1-minute intervals. In the infusion group, the infusion rate was automatically adjusted after each BP measurement using a previously described algorithm. In the bolus group, the algorithm was modified so that the mass of drug that would have been delivered over 1 minute was instead injected as a rapid intravenous bolus after each BP measurement. The precision of BP control was assessed using performance error calculations and compared between groups, with the primary outcome defined as median absolute performance error, and the latter being a measure of inaccuracy showing an average of the magnitudes of the differences of measured BP values above or below the target values.
  
  
  
  The precision of BP control was greater, as shown by smaller values for median absolute performance error, in the bolus group (median 4.38 [quartiles 3.22, 6.25] %) versus the infusion group (5.39 [4.12, 7.04] %, P = .008). In the bolus group, phenylephrine consumption was smaller; this was associated with smaller values for median performance error compared with the continuous infusion group (P < .001), which indicates that values for systolic BP, averaged over time, were slightly lower in the bolus group. There were no differences in cardiac output, nausea or vomiting, or neonatal outcome between groups.
  
  
  
  We confirmed the hypothesis that BP control was more precise when computer-controlled phenylephrine was delivered using intermittent boluses rather than continuous infusion. However, the difference between groups was small and was not associated with any difference in clinical outcomes. In the infusion group, greater doses of phenylephrine were delivered, which was related to the time taken for the noninvasive BP monitor to complete measurements. The use of intermittent boluses may be a useful alternative in the design of closed-loop vasopressor systems.
authors.affiliation: From the *Department of Anaesthesia and Intensive Care, the Chinese University of Hong Kong, China; and †Department of Health Technology and Informatics, the Hong Kong Polytechnic University, Hung Hom, Hong Kong.
authors.forename: Warwick D
authors.initials: WD
authors.lastname: Ngan Kee
authors.forename: Yuk-Ho
authors.initials: YH
authors.lastname: Tam
authors.forename: Kim S
authors.initials: KS
authors.lastname: Khaw
authors.forename: Floria F
authors.initials: FF
authors.lastname: Ng
authors.forename: Shara W Y
authors.initials: SWY
authors.lastname: Lee
mesh_terms: D000328:Adult; D000758:Anesthesia; D000773:Anesthesia, Obstetrical / Q000379:methods*; D000775:Anesthesia, Spinal / Q000379:methods*; D001794:Blood Pressure / Q000187:drug effects*; D001795:Blood Pressure Determination; D002302:Cardiac Output / Q000187:drug effects; D002585:Cesarean Section; D003201:Computers; D004311:Double-Blind Method; D016503:Drug Delivery Systems / Q000295:instrumentation; D004360:Drug Therapy, Computer-Assisted; D005246:Feedback; D005260:Female; D006439:Hemodynamics; D006801:Humans; D007022:Hypotension / Q000188:drug therapy; D007262:Infusions, Intravenous; D010656:Phenylephrine / Q000008:administration & dosage*; D011247:Pregnancy; D015203:Reproducibility of Results; D016037:Single-Blind Method; D013997:Time Factors; D014662:Vasoconstrictor Agents / Q000008:administration & dosage
chemical_list: D014662:Vasoconstrictor Agents; D010656:Phenylephrine