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End-Tidal Control Versus Manual Control of Inhalational Anesthesia Delivery: A Randomized Controlled Noninferiority

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The End-tidal Control (EtC) system provides precise anesthetic delivery, matching manual control (MC) performance. EtC achieved and maintained target anesthetic and oxygen concentrations more effectively than MC.

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Area of Science:

  • Anesthesiology
  • Medical Devices
  • Clinical Trials

Background:

  • Precise anesthesia delivery is crucial for patient amnesia, analgesia, and immobility.
  • Manual adjustment of anesthetic delivery systems is conventional but can be imprecise.
  • Closed-loop systems offer automated control of anesthetic concentrations.

Purpose of the Study:

  • To evaluate the performance of the End-tidal Control (EtC) system on the Aisys CS 2 anesthesia machine.
  • To test the hypothesis that EtC anesthetic delivery is noninferior to manual control (MC).

Main Methods:

  • The MASTER Trial randomized 210 adult patients to EtC or MC anesthetic delivery.
  • Noninferiority was assessed by comparing the percentage of time EtAA and EtO2 concentrations remained within defined limits.
  • Secondary outcomes included response time, overshoot, and accuracy.

Main Results:

  • EtC maintained target EtAA concentrations within 5% of the desired value 98% of the time, compared to 45.7% for MC.
  • EtC kept EtO2 within limits 86.3% of the time versus 41% for MC.
  • EtC showed a faster median response time (75s vs. 158s) and less deviation from target EtAA.

Conclusions:

  • The EtC system achieves and maintains end-tidal anesthetic agent (EtAA) and end-tidal oxygen (EtO2) concentrations non-inferiorly to manual control.
  • EtC offers improved precision and faster response in anesthetic delivery.
  • Automated anesthetic delivery systems like EtC enhance anesthesia management.