Are anesthesiologists on the verge of being replaced by a new robot? In a word, “No.” The new device being discussed is the iControl-RP anesthesia robot.
THE iCONTROL-RP ANESTHESIA ROBOT
On May 15, 2015, the Washington Post published a story titled, “We Are Convinced the Machine Can Do Better Than Human Anesthesiologists.”
In recent years there have been significant advances in the automated delivery of the intravenous anesthetic drugs propofol and remifentanil. (Orliaguet GA, Feasibility of closed-loop titration of propofol and remifentanil guided by the bispectral monitor in pediatric and adolescent patients: a prospective randomized study, Anesthesiology 2015 Apr;122(4):759-67). Propofol is an ultra-short-acting hypnotic drug that causes sleep. Remifentanil is an ultra-short-acting narcotic that relieves pain. Administered together, these drugs induce what is referred to as Total Intravenous Anesthesia, or TIVA. Total Intravenous Anesthesia is a technique anesthesiologists use when they choose to avoid using inhaled gases such as sevoflurane and nitrous oxide. Anesthesiologists administer TIVA by adjusting the flow rates on two separate infusion pumps, one infusion pump containing each drug.
A closed-loop system is a machine that infuses these drugs automatically. These systems include several essential items: The first is a processed electroencephalogram (EEG) such as a bi-spectral monitor (BIS monitor) attached to the patient’s forehead which records a neurologic measure of how asleep the patient is. The BIS monitor calculates a score between 0 and 100 for the patient’s level of unconsciousness, with a score of 100 corresponding to wide awake and 0 corresponding to a flat EEG. A score of 40 – 60 is considered an optimal amount of anesthesia depth. The second and third essential items of a closed-loop automated system are two automated infusion pumps containing propofol and remifentanil. A computer controls the infusion rate of a higher or lower amount of these drugs, depending on whether the measured BIS score is higher or lower than the 40- 60 range.
Researchers in Canada have expanded this technology into a device they call the iControl-RP, which is in clinical trials at the University of British Columbia. The iControl-RP is a closed-loop system which makes its own decisions. The initials RP stand for the two drugs being titrated: remifentanil and propofol. In addition to monitoring the patient’s EEG level of consciousness (via a BIS monitor device called NeuroSENSE), this new device monitors traditional vital signs such as blood oxygen levels, heart rate, respiratory rate, and blood pressure, to determine how much anesthesia to deliver.
Per published information on their research protocol, the iControl-RP allows either remifentanil or propofol to be operated in any of three modes: (1) closed-loop control based on feedback from the EEG as measured by the NeuroSENSE; (2) target-controlled infusion (TCI), based on previously-described pharmacokinetic and pharmacodynamic models; and (3) conventional manual infusion, which requires a weight-based dose setting. (Reference: Closed-loop Control of Anesthesia: Controlled Delivery of Remifentanil and Propofol Dates, Status, Enrollment Verified by: Fraser Health, August 2014, First Received: January 15, 2013, Last Updated: March 5, 2015, Phase: N/A, Start Date: February 2013, Overall Status: Recruiting, Estimated Enrollment: 150).
In Phase 1 of the iControl-RP testing involving 50 study subjects, propofol will be administered in closed-loop mode and a remifentanil infusion will be administered based on a target-controlled infusion. In phase 2 involving 100 study subjects, both propofol and remifentanil will be administered in closed-loop mode. The investigators aim to demonstrate that closed-loop control of anesthesia and analgesia based on EEG feedback is clinically feasible.
In both phases, an anesthesiologist will monitor the patient as per routine practice and have the ability to modify the anesthetic or analgesic drugs being administered. That is, he or she will be able to adjust the target depth of hypnosis, adjust the target effect site concentration for remifentanil, immediately switch to manual control of either infusion, administer a bolus dose, or immediately stop the infusion of either drug. iControl-RP is connected to the NeuroSENSE EEG monitor, the two infusion pumps for separately controlled propofol and remifentanil administration, and the operating room patient vital signs monitor. A user interface allows the anesthesiologist to set the target EEG depth level, switch between modes of operation (manual, target-controlled infusion, or closed-loop), and set manual infusion rates or target effect-site concentrations for either drug as required.
Per the article in the Washington Post. (Todd C. Frankel, Washington Post, May 15, 2015), one of the machine’s co-developers Mark Ansermino, MD said, “We are convinced the machine can do better than human anesthesiologists.” The iControl-RP has been used to induce deep sedation in adults and children undergoing general surgery. The device had been used on 250 patients so far.
Why is this robotic device only a small step toward replacing anesthesiologists?
A critical realization is that anesthetizing patients requires far more skill than merely titrating two drug levels. Every patient requires (1) preoperative assessment of all medical problems from the history, physical exam, and laboratory evaluation of each individual patient, so that the anesthesiologist can plan and prescribe the appropriate anesthesia type; (2) placement of an intravenous line through which the TIVA drugs may be administered; (3) mask ventilation of an unconscious patient (in most cases), followed by placement of an airway tube to control the delivery of oxygen and ventilation in and out of the patient’s lungs; (4) observation of all vital monitors during surgery, with the aim of directing the diagnosis and treatment of any complication that occurs as a result of anesthesia or the surgical procedure; (5) removal of the airway tube at the conclusion of most surgeries, and (6) the diagnosis and treatment of any complication in the newly awake patient following the anesthetic.
In the future, closed-loop titration of drugs may lessen an anesthesiologist’s workload and free him or her for other activities. In the distant future, closed-loop titration of drugs may free a solitary anesthesiologist to initiate and monitor multiple anesthetics simultaneously from a control booth via multiple video screens and interface displays. But the handling of all tasks (1) – (6) by an automated robotic device is still the stuff of science fiction. The Washington Post article said an early role for the machine could be in war zones or remote areas where an anesthesiologist is unavailable. One could conjecture that a closed-loop anesthesia system may be used to facilitate surgery in outer space some day as well.
In either case, an anesthesiologist or some other highly-trained medical professional will still be required on site to achieve tasks (1) – (6).
The iControl-RP has not been approved by the U.S. Food and Drug Administration.
The iControl-RP team has struggled to find a corporate backer for its project. Dr. Ansermino, the anesthesiologist inventor in Vancouver, told the Washington Post, “Most big companies view this as too risky,” but he believed a device like this was inevitable. “I think eventually this will happen,” Ansermino told the Washington Post, “whether we like it or not.”
That may be, but I suspect companies are risk averse regarding the iControl-RP because investment is guided by analysts and physicians who must consider the practical applications and risks of any new medical device. The issues of leaving (1) – (6) up to a robotic device are impractical at best, and dangerous to the patient at worse.
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