Multi-site Anesthesia Randomized Controlled STudy of End Tidal Control (Et Control) Compared to Conventional Anesthesia Results (MASTER-Anesthesia Trial)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Et Control Performance in Adult Population Surgery
- Sponsor
- GE Healthcare
- Enrollment
- 248
- Locations
- 4
- Primary Endpoint
- Percent Duration Without Large Deviation of End-Tidal Oxygen (EtO2) Based on Extraction Algorithm (ALG)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female 18 years old or greater.
- •Scheduled to undergo general inhaled anesthesia that can be safely exposed to 100% oxygen for up to 2 minutes during general anesthesia.
- •Expected to have airway secured with laryngeal mask airway (LMA) or endotracheal tube.
- •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).
- •American Society of Anesthesiologists (ASA) status classification system I through III:
- •ASA Physical Status 1 = a normal healthy patient
- •ASA Physical Status 2 = a patient with mild systemic disease
- •ASA Physical Status 3 = a patient with severe systemic disease
- •Undergoing intravenous induction.
- •Ability to provide written informed consent.
Exclusion Criteria
- •Have emergency medical condition requiring surgery.
- •Are female subjects, who are pregnant or lactating.
- •Any subject undergoing cardiac bypass surgery.
- •Any subject undergoing open chest surgery.
Outcomes
Primary Outcomes
Percent Duration Without Large Deviation of End-Tidal Oxygen (EtO2) Based on Extraction Algorithm (ALG)
Time Frame: Duration of each steady state, an average of approximately 60 minutes
Percent duration of EtAA concentration during steady state maintained within the acceptable limit, which is defined as the greater of 5% of the steady state inhaled anesthetic agent concentration and 0.6% v/v for Desflurane (Des), 0.2% v/v for Sevoflurane (Sev), or 0.1% v/v for Isoflurane (Iso). The percent duration is the weighted average of all steady states for a subject, using the duration of steady state as the weight. Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).
Percent Duration Without Large Deviation of End-Tidal Anesthetic Agent (EtAA) Based on Extraction Algorithm (ALG)
Time Frame: Duration of each steady state, an average of approximately 60 minutes
Percent duration of EtAA concentration during steady state maintained within the acceptable limit, which is defined as the greater of 5% of the steady state inhaled anesthetic agent concentration and 0.6% v/v for Desflurane (Des), 0.2% v/v for Sevoflurane (Sev), or 0.1% v/v for Isoflurane (Iso). The percent duration is the weighted average of all steady states for a subject, using the duration of steady state as the weight. Steady state concentration is based on an extraction algorithm described in Appendix 2 of the protocol.
Percent Duration Without Large Deviation of EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)
Time Frame: Duration of each steady state, an average of approximately 60 minutes
Percent duration of EtAA concentration during steady state maintained within the acceptable limit, which is defined as the greater of 5% of the steady state inhaled anesthetic agent concentration and 0.6% v/v for Desflurane (Des), 0.2% v/v for Sevoflurane (Sev), or 0.1% v/v for Isoflurane (Iso). The percent duration is the weighted average of all steady states for a subject, using the duration of steady state as the weight. Data obtained using the clinicians' or Investigators' recorded target (TGT) values of anesthetic agent and oxygen for the Control Arm and using the set target values for the Et Control Arm.
Percent Duration Without Large Deviation of EtO2 Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)
Time Frame: Duration of each steady state, an average of approximately 60 minutes
Percent duration of EtAA concentration during steady state maintained within the acceptable limit, which is defined as the greater of 5% of the steady state inhaled anesthetic agent concentration and 0.6% v/v for Desflurane (Des), 0.2% v/v for Sevoflurane (Sev), or 0.1% v/v for Isoflurane (Iso). The percent duration is the weighted average of all steady states for a subject, using the duration of steady state as the weight. Values based on clinicians' or Investigators' recorded target values (TGT)
Secondary Outcomes
- Efficacy Response Time EtAA Based on Extraction Algorithm (ALG)(Duration of each steady state, an average of approximately 60 minutes)
- Efficacy: Settling Time for EtO2 Based on the Extraction Algorithm (ALG)(Duration of each steady state, an average of approximately 60 minutes)
- Efficacy: Overshoot Amount of Desired EtO2 Amount Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)(Duration of each steady state, an average of approximately 60 minutes)
- 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)(Duration of Surgery)
- Efficacy: Response Time for EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)(Duration of each steady state, an average of approximately 60 minutes)
- Efficacy Response Time for EtO2 Based on Extraction Algorithm (ALG)(Duration of each steady state, an average of approximately 60 minutes.)
- Efficacy: Response Time for EtO2 Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)(Duration of each steady state, an average of approximately 60 minutes)
- Efficacy: Settling Time for EtAA Based on the Extraction Algorithm (ALG)(Duration of each steady state, an average of approximately 60 minutes)
- Efficacy: Settling Time for EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)(Duration of each steady state, an average of approximately 60 minutes)
- Efficacy: Settling Time for EtO2 Based on Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)(Duration of each steady state, an average of approximately 60 minutes)
- Efficacy: Overshoot Amount of the Desired EtAA Amount Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)(Duration of each steady state, an average of approximately 60 minutes)
- Efficacy: Overshoot Amount of Desired EtO2 Amount Based on the Extraction Algorithm (ALG)(Duration of each steady state, an average of approximately 60 minutes)
- Efficacy: Overshoot Amount of the Desired EtAA Based on Extraction Algorithm (ALG)(Duration of each steady state, an average of approximately 60 minutes)
- Accuracy of Et Control in Maintaining EtAA Control Between User Set Target and Settling End Tidal Concentrations Based on the Extraction Algorithm (ALG)(Duration of surgery, average of 112.1 minutes (+/- 78.7 minutes))
- Accuracy of Et Control in Maintaining EtO2 Between User Set Target and Settling End Tidal Concentrations Based on the Extraction Algorithm (ALG)(Duration of surgery, average of 112.1 minutes (+/- 78.7 minutes))
- 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)(Duration of surgery, average of 112.1 minutes (+/- 78.7 minutes))