Use of a decision support system improves the management of hemodynamic and respiratory events in orthopedic patients under propofol sedation and spinal analgesia: a randomized trial.

Decision support systems (DSSs) have been successfully implemented into clinical practice offering clinical suggestions and treatment options with excellent results in various clinical settings. Although their results appeared promising, showing that DSSs can increase anesthesiologists' vigilance and patient safety during surgery, DSSs have never been used before to help anesthesiologists in identifying critical events in patients under spinal analgesia with sedation. We have developed and clinically evaluated a DSS for this specific task. The DSS was developed with the ability to indicate respiratory and hemodynamic critical events via audio-visual alarms and give decisional aid. Critical respiratory events were defined as SpO2 <92 % and/or respiratory rate <8/min. Critical hemodynamic events were defined as mean arterial pressure (MAP) <60 mmHg and/or heart rate <40 bpm. The objective of this trial was to determine the duration to detect and treat these critical events with the help of the DSS (DSS Group) compared with a standard Control Group where the system was not in place. One hundred and fifty orthopedic patients undergoing spinal analgesia with propofol sedation were enrolled in this randomized control trial, 75 each group. All respiratory and hemodynamic critical events were detected in the DSS Group, while in the Control Group 26 % of the events were not detected.The delay to detect and treat critical events was significantly shorter (P < 0.0001) in the DSS Group at 9.1 ± 3.6 s, whereas 27.5 ± 18.9 s were necessary to identify them in the Control Group. There were no significant differences in physiological parameters in the two groups during surgery. The number of critical events/h occurring and the duration of surgery were similar in both groups. The number of hypoxemia episodes was significantly less (P = 0.036) in the DSS group (0.7 ± 1.0 vs. 1.4 ± 2.2 for the Control Group). The DSS tested in this trial could help the clinician to detect and treat critical events more efficiently and in a shorter length of time.

Relaxofon: a neuromuscular blockade monitor for patients under general anesthesia.

Anesthesia consists of three components: unconsciousness, analgesia and neuromuscular blockade (NMB). A specific drug is administered by the anesthesiologist to control these different components. In this paper we propose a new system for monitoring the neuromuscular blockade in anesthesized patients during surgery. Neuromuscular blockade drugs are used routinely by clinicians to induce muscle relaxation in patients. However, the use of these drugs has some risks, so an adequate monitoring of the effects of these drugs is essential. This paper describes the Relaxofon, a NMB monitoring device based on phonomyography. The Relaxofon is composed of a hardware subsystem that records muscle sounds using microphones and a special circuit to filter out the noise and amplify the signal, and a software subsystem that analyses the acquired signal. We tested the ability of the system to record phonomyographic signals from the adductor pollicis and the corrugator supercilii muscles. We then performed the Bland-Altman test to compare the manual Train-of-Four ratio (a measure of the depth of muscle relaxation) calculation against the one performed by the Relaxofon. Finally, we calculated the Pearson correlation coefficient to measure the linear dependence between the two methods. Automatic Train-of-Four ratio calculations using this system showed very good agreement with manual calculations. Results from this work may ultimately lead to integration of NMB monitoring to an automated closed-loop anesthesia system.

A randomized controlled trial demonstrates that a novel closed-loop propofol system performs better hypnosis control than manual administration.

PURPOSE: The purpose of this randomized control trial was to determine the performance of a novel rule-based adaptive closed-loop system for propofol administration using the bispectral index (BIS(R)) and to compare the system's performance with manual administration. The effectiveness of the closed-loop system to maintain BIS close to a target of 45 was determined and compared with manual administration. METHODS: After Institutional Review Board approval and written consent, 40 patients undergoing major surgery in a tertiary university hospital were allocated to two groups using computer-generated block randomization. In the Closed-loop group (n = 20), closed-loop control was used to maintain anesthesia at a target BIS of 45, and in the Control group (n = 20), propofol was administered manually to maintain the same BIS target. To evaluate each technique's performance in maintaining a steady level of hypnosis, the BIS values obtained during the surgical procedure were stratified into four clinical performance categories relative to the target BIS: < or = 10%, 11-20%, 21-30%, or > 30% defined as excellent, good, poor, or inadequate control of hypnosis, respectively. The controller performance was compared using Varvel's controller performance indices. Data were compared using Fisher's exact test and the Mann-Whitney U test, P < 0.05 showing statistical significance. RESULTS: In the Closed-loop group, four females and 16 males (aged 54 +/- 20 yr; weight 79 +/- 7 kg) underwent anesthesia lasting 143 +/- 57 min. During 55%, 29%, 9%, and 7% of the total anesthesia time, the system showed excellent, good, poor, and inadequate control, respectively. In the Control group, five females and 15 males (aged 59 +/- 16 yr; weight 75 +/- 13 kg) underwent anesthesia lasting 157 +/- 81 min. Excellent, good, poor, and inadequate control were noted during 33%, 33%, 15%, and 19% of the total anesthesia time, respectively. In the Closed-loop group, excellent control of anesthesia occurred significantly more often (P < 0.0001), and poor and inadequate control occurred less often than in the Control group (P < 0.01). The median performance error and the median absolute performance error were significantly lower in the Closed-loop group compared with the Control group (-1.1 +/- 5.3% vs -10.7 +/- 13.1%; P = 0.004 and 9.1 +/- 1.9% vs 15.7 +/- 7.4%; P < 0.0001, respectively). CONCLUSION: The closed-loop system for propofol administration showed better clinical and control system performance than manual administration of propofol. (Clinical Trials gov. NCT 01019746).