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

NACompletedINTERVENTIONAL
Enrollment

248

Participants

Timeline

Start Date

June 9, 2017

Primary Completion Date

September 5, 2018

Study Completion Date

September 5, 2018

Conditions
Et Control Performance in Adult Population Surgery
Interventions
DEVICE

Et Control Feature

Subjects using Et Control option; the investigator will use and initiate Et Control after the airway is secured and mechanical ventilation is initiated. Machine log data is collected when the investigator initiates the start of anesthesia case on the Aisys CS2. Adjustments to the anesthesia machine settings, discontinuation of use of the investigational Et Control option, and changes to treatment are based upon clinician judgment for the wellbeing of the subject. The clinician must continuously monitor measured inspired and end tidal oxygen and anesthetic concentrations to assess individual responses and compare to the target concentrations.

DEVICE

Conventional Fresh Gas

"Subjects to undergo a surgical procedure with inhaled anesthesia meeting the American Society of Anesthesiologists status classification system 1-3. Subjects using conventional option; the investigator will use their conventional means to adjust the vaporizer and mixer, and monitor the patient gas concentrations with the legally marketed Aisys CS2 anesthesia machine without the investigational Et Control feature. Machine log data collection will end, when an end case is confirmed on the Aisys CS2 at the end of the anesthesia case."

Trial Locations (4)

27710

Duke University, Durham

30322

Emory University Hospital, Atlanta

52242

University of Iowa Healthcare, Iowa City

92354

Loma Linda University, Loma Linda

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GE Healthcare

INDUSTRY