CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 248 enrolled
Drug / intervention
Et Control Feature +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02972892
NCT02972892N/ACompleted

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

GE Healthcare·interventional·Posted Nov 25, 2016·Updated Nov 2, 2022

In Brief

A clinical study evaluating Et Control Feature and Conventional Fresh Gas for Et Control Performance in Adult Population Surgery. Completed, enrolled 248 participants across 4 sites.

Detailed Summary

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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedNov 25, 2016
Enrollment StartJun 9, 2017
Primary CompletionSep 5, 2018
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 9.6 years ago

Interventions

Et Control Featuredevice

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.

Conventional Fresh Gasdevice

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.