Multi-site Anesthesia Randomized Controlled STudy of End Tidal Control Compared to Conventional Anesthesia Results

Multi-site Anesthesia Randomized Controlled STudy of End Tidal Control (Et Control) Compared to Conventional Anesthesia Results (MASTER-Anesthesia Trial)

This is a clinical, single blind, randomized, prospective research study. The purpose of this pivotal study is to collect and analyze data on the investigational End tidal Control (Et Control) option feature. To demonstrate that End tidal Control (Et Control) performance is non-inferior to conventional anesthesia practice in an adult surgery population by comparing the performance of the Et Control Arm (investigational arm) to the Control Arm (fresh gas mode).

The purpose of this pivotal study is to demonstrate that End tidal Control performance is non-inferior to conventional anesthesia practice in an adult surgery population, and support a marketing application in the U.S. for clearance of this feature.

Inclusion Criteria:

1. Male or female 18 years old or greater.

2. Scheduled to undergo general inhaled anesthesia that can be safely exposed to 100% oxygen for up to 2 minutes during general anesthesia.

3. Expected to have airway secured with laryngeal mask airway (LMA) or endotracheal tube.

4. Undergoing a surgical procedure that is anticipated by the investigator to take greater than or equal to 1 hour (operative time measured from induction to cessation of general inhalation anesthetic).

5. American Society of Anesthesiologists (ASA) status classification system I through III:

   1. ASA Physical Status 1 = a normal healthy patient
   2. ASA Physical Status 2 = a patient with mild systemic disease
   3. ASA Physical Status 3 = a patient with severe systemic disease

6. Undergoing intravenous induction.

7. Ability to provide written informed consent.

Exclusion Criteria:

1. Have emergency medical condition requiring surgery.
2. Are female subjects, who are pregnant or lactating.
3. Any subject undergoing cardiac bypass surgery.
4. Any subject undergoing open chest surgery.