Clinical trial NCT02972892: Multi-site Anesthesia Randomized Controlled STudy of End Tidal Control Compared to Conventional Anesthesia Results
Official title: Multi-site Anesthesia Randomized Controlled STudy of End Tidal Control (Et Control) Compared to Conventional Anesthesia Results (MASTER-Anesthesia Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Et Control Performance in Adult Population Surgery
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2016-11-25
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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).

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percent Duration Without Large Deviation of End-Tidal Anesthetic Agent (EtAA) Based on Extraction Algorithm (ALG)
timeFrame: Duration of each steady state, an average of approximately 60 minutes
measure: Percent Duration Without Large Deviation of EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)
timeFrame: Duration of each steady state, an average of approximately 60 minutes
measure: Percent Duration Without Large Deviation of End-Tidal Oxygen (EtO2) Based on Extraction Algorithm (ALG)
timeFrame: Duration of each steady state, an average of approximately 60 minutes
measure: Percent Duration Without Large Deviation of EtO2 Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)
timeFrame: Duration of each steady state, an average of approximately 60 minutes
Secondary outcomes:
measure: Efficacy Response Time EtAA Based on Extraction Algorithm (ALG)
timeFrame: Duration of each steady state, an average of approximately 60 minutes
measure: Efficacy: Response Time for EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)
timeFrame: Duration of each steady state, an average of approximately 60 minutes
measure: Efficacy Response Time for EtO2 Based on Extraction Algorithm (ALG)
timeFrame: Duration of each steady state, an average of approximately 60 minutes.
measure: Efficacy: Response Time for EtO2 Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)
timeFrame: Duration of each steady state, an average of approximately 60 minutes
measure: Efficacy: Settling Time for EtAA Based on the Extraction Algorithm (ALG)
timeFrame: Duration of each steady state, an average of approximately 60 minutes
measure: Efficacy: Settling Time for EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)
timeFrame: Duration of each steady state, an average of approximately 60 minutes
measure: Efficacy: Settling Time for EtO2 Based on the Extraction Algorithm (ALG)
timeFrame: Duration of each steady state, an average of approximately 60 minutes
measure: Efficacy: Settling Time for EtO2 Based on Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)
timeFrame: Duration of each steady state, an average of approximately 60 minutes
measure: Efficacy: Overshoot Amount of the Desired EtAA Based on Extraction Algorithm (ALG)
timeFrame: Duration of each steady state, an average of approximately 60 minutes
measure: Efficacy: Overshoot Amount of the Desired EtAA Amount Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)
timeFrame: Duration of each steady state, an average of approximately 60 minutes
measure: Efficacy: Overshoot Amount of Desired EtO2 Amount Based on the Extraction Algorithm (ALG)
timeFrame: Duration of each steady state, an average of approximately 60 minutes
measure: Efficacy: Overshoot Amount of Desired EtO2 Amount Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)
timeFrame: Duration of each steady state, an average of approximately 60 minutes
measure: Accuracy of Et Control in Maintaining EtAA Control Between User Set Target and Settling End Tidal Concentrations Based on the Extraction Algorithm (ALG)
timeFrame: Duration of surgery, average of 112.1 minutes (+/- 78.7 minutes)
measure: Accuracy of ET Control in Maintaining EtAA Control Between User Set Target and Settling End Tidal Concentrations Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)
timeFrame: Duration of Surgery
measure: Accuracy of Et Control in Maintaining EtO2 Between User Set Target and Settling End Tidal Concentrations Based on the Extraction Algorithm (ALG)
timeFrame: Duration of surgery, average of 112.1 minutes (+/- 78.7 minutes)
measure: Accuracy of Et Control in Maintaining EtO2 Between User Set Target and Settling End Tidal Concentrations Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)
timeFrame: Duration of surgery, average of 112.1 minutes (+/- 78.7 minutes)
Other outcomes:
measure: Inhaled Anesthetic Agent
timeFrame: Duration of Procedure
measure: User Interactions
timeFrame: Duration of Procedure
measure: Discharge From the Operating Room
timeFrame: End of surgery to time of last breath
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Iowa City
country: United States
facility: University of Iowa Healthcare
state: Iowa
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: University of Iowa Healthcare
name: Melinda Seering, MD
role: PRINCIPAL_INVESTIGATOR
References: