Multi-site Anesthesia Randomized Controlled STudy of End Tidal Control (Et Control) Compared to Conventional Anesthesia Results (MASTER-Anesthesia Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 248
- 试验地点
- 4
- 主要终点
- Percent Duration Without Large Deviation of End-Tidal Oxygen (EtO2) Based on Extraction Algorithm (ALG)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Et Control
Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using the investigational Et Control option intervention. For Subjects under the 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 well being of the subject.
干预措施: Et Control Feature (Device)
Control Arm
Subjects, meeting the American Society of Anesthesiologists status classification system 1-3, to undergo a surgical procedure with inhaled anesthesia using conventional fresh gas intervention. For subjects under the 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.
干预措施: Conventional Fresh Gas (Device)
结局指标
主要结局
Percent Duration Without Large Deviation of End-Tidal Oxygen (EtO2) Based on Extraction Algorithm (ALG)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
次要结局
- 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))