- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02972892
Multi-site Anesthesia Randomized Controlled STudy of End Tidal Control Compared to Conventional Anesthesia Results
October 5, 2022 updated by: GE Healthcare
Multi-site Anesthesia Randomized Controlled STudy of End Tidal Control (Et Control) Compared to Conventional Anesthesia Results (MASTER-Anesthesia Trial)
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 Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
248
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Loma Linda, California, United States, 92354
- Loma Linda University
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University Hospital
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa Healthcare
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
|
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.
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ACTIVE_COMPARATOR: 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Duration of each steady state, an average of approximately 60 minutes
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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.
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Duration of each steady state, an average of approximately 60 minutes
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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).
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Duration of each steady state, an average of approximately 60 minutes
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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)
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Duration of each steady state, an average of approximately 60 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy Response Time EtAA Based on Extraction Algorithm (ALG)
Time Frame: Duration of each steady state, an average of approximately 60 minutes
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Response time: time to reach 90% of the desired change in EtAA steady state mean concentration.
Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).
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Duration of each steady state, an average of approximately 60 minutes
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Efficacy: Response Time for 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
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time to reach 90% of the desired change in EtAA and EtO2 steady state mean concentration.
Values based on clinicians' or Investigators' recorded values (TGT).
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Duration of each steady state, an average of approximately 60 minutes
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Efficacy Response Time for EtO2 Based on Extraction Algorithm (ALG)
Time Frame: Duration of each steady state, an average of approximately 60 minutes.
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Response time: time to reach 90% of the desired change in EtO2 steady state mean concentration.
Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).
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Duration of each steady state, an average of approximately 60 minutes.
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Efficacy: Response Time for 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
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Response time: time to reach 90% of the desired change in EtAA and EtO2 steady state mean concentration.
Values based on clinicians' or Investigators' recorded values (TGT).
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Duration of each steady state, an average of approximately 60 minutes
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Efficacy: Settling Time for EtAA Based on the Extraction Algorithm (ALG)
Time Frame: Duration of each steady state, an average of approximately 60 minutes
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Settling time: time to achieve the desired EtAA steady state mean concentration.
Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).
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Duration of each steady state, an average of approximately 60 minutes
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Efficacy: Settling Time for 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
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Settling time: time to achieve the desired EtAA steady state mean concentration.
Values based on clinicians' or Investigators' recorded values (TGT).
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Duration of each steady state, an average of approximately 60 minutes
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Efficacy: Settling Time for EtO2 Based on the Extraction Algorithm (ALG)
Time Frame: Duration of each steady state, an average of approximately 60 minutes
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Settling time: time to achieve the desired EtO2 steady state mean concentration.
Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).
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Duration of each steady state, an average of approximately 60 minutes
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Efficacy: Settling Time for EtO2 Based on 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
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time to achieve the desired EtO2 steady state mean concentration.
Values based on clinicians' or Investigators' recorded values (TGT).
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Duration of each steady state, an average of approximately 60 minutes
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Efficacy: Overshoot Amount of the Desired EtAA Based on Extraction Algorithm (ALG)
Time Frame: Duration of each steady state, an average of approximately 60 minutes
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Overshoot amount of the desired EtAA from steady state mean concentration.
Command Overshoot is defined as the maximum value beyond the desired end tidal concentration from the start of the step change until the Settling Time.
Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).
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Duration of each steady state, an average of approximately 60 minutes
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Efficacy: Overshoot Amount of the Desired EtAA Amount 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
|
Overshoot amount of the desired EtAA from steady state mean concentration.
Command Overshoot is defined as the maximum value beyond the desired end tidal concentration from the start of the step change until the Settling Time.
Values based on clinicians' or Investigators' recorded values (TGT).
|
Duration of each steady state, an average of approximately 60 minutes
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Efficacy: Overshoot Amount of Desired EtO2 Amount Based on the Extraction Algorithm (ALG)
Time Frame: Duration of each steady state, an average of approximately 60 minutes
|
Overshoot amount of the desired EtO2 from steady state mean concentration.
Command Overshoot is defined as the maximum value beyond the desired end tidal concentration from the start of the step change until the Settling Time.
Values based on the extraction algorithm described in Appendix 2 of the protocol (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)
Time Frame: Duration of each steady state, an average of approximately 60 minutes
|
Overshoot amount of the desired EtO2 from steady state mean concentration.
Command Overshoot is defined as the maximum value beyond the desired end tidal concentration from the start of the step change until the Settling Time.
Values based on clinicians' or Investigators' recorded values (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 the Extraction Algorithm (ALG)
Time Frame: Duration of surgery, average of 112.1 minutes (+/- 78.7 minutes)
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Accuracy of Et Control in maintaining EtAA control between user set target and settling end tidal concentrations.
Calculated for Et Control arm only.
The accuracy measures include absolute difference between steady state and set EtAA concentrations.
The acceptable limits defined by the primary endpoint were: 0.1% of Isoflurane, 0.2% for Sevoflurane, 0.6% for Desflurane.
As a measure of Absolute Difference between Steady State and Set EtAA Concentration (%).
Values based on the extraction algorithm described in Appendix 2 of the protocol (ALG).
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Duration of surgery, average of 112.1 minutes (+/- 78.7 minutes)
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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)
Time Frame: Duration of Surgery
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Accuracy of ET Control in maintatining EtAA between user set target and settling end tidal concentrations.
Calculated for ET Control arm only.
The accuracy measures include absolute difference between steady state and set EtAA concentrations.
The acceptable limits defined by the primary endpoint were: 0.1% of Isoflurane, 0.2% for Sevoflurane, 0.6% for Desflurane.
Values based on clinicians' or Investigators' recorded values (TGT).
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Duration of Surgery
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Accuracy of Et Control in Maintaining EtO2 Between User Set Target and Settling End Tidal Concentrations Based on the Extraction Algorithm (ALG)
Time Frame: Duration of surgery, average of 112.1 minutes (+/- 78.7 minutes)
|
Accuracy of Et Control in maintaining EtO2 control between user set target and settling end tidal concentrations.
Calculated for Et Control arm only.
outcome measures the absolute difference between Steady State and Set EtO2 Concentrations.
The acceptable limit defined by the primary endpoint was < 5% v/v.
Values based on the extraction algorithm described in Appendix 2 of the protocol (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)
Time Frame: Duration of surgery, average of 112.1 minutes (+/- 78.7 minutes)
|
Accuracy of Et Control in maintaining EtO2 control between user set target and settling end tidal concentrations.
Calculated for Et Control arm only.
outcome measures the absolute difference between Steady State and Set EtO2 Concentrations.
The acceptable limit defined by the primary endpoint was < 5% v/v.
Values based on clinicians' or Investigators' recorded values (TGT).
|
Duration of surgery, average of 112.1 minutes (+/- 78.7 minutes)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inhaled Anesthetic Agent
Time Frame: Duration of Procedure
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Usage of inhaled anesthetic agent
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Duration of Procedure
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User Interactions
Time Frame: Duration of Procedure
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Number of user interactions
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Duration of Procedure
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Discharge From the Operating Room
Time Frame: End of surgery to time of last breath
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Time to discharge from the operating room
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End of surgery to time of last breath
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Melinda Seering, MD, University of Iowa Healthcare
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 9, 2017
Primary Completion (ACTUAL)
September 5, 2018
Study Completion (ACTUAL)
September 5, 2018
Study Registration Dates
First Submitted
November 14, 2016
First Submitted That Met QC Criteria
November 21, 2016
First Posted (ESTIMATE)
November 25, 2016
Study Record Updates
Last Update Posted (ACTUAL)
November 2, 2022
Last Update Submitted That Met QC Criteria
October 5, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 123.07-2015-GES-0002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data to be shared and reviewed are: adverse events listing, serious adverse event (SAE)/unanticipated adverse device effects (UADE) summary, demographics, surgical procedure, treatment allocation, early termination, critical protocol deviations, device malfunction reports, and plotted data (Et Control subjects with adverse events only).
These items are listed in the Data Safety Monitoring Board (DSMB) Charter.
IPD Sharing Time Frame
Data will be available according to the following timeline: (1) when a minimum of 20 Et Control subjects enrolled and at least 2 sites initiated and enrolling; (2) 50% enrollment; (3) 80% enrollment; and (4) 100% enrollment.
IPD Sharing Access Criteria
Members of the DSMB will have access to the data listed under the Plan Description section.
Reports will consist of tables, listings, and figures; and will be delivered electronically at least 7 calendar days prior to the date of each DSMB meeting.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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