Et Control Performance in Adult Population SurgeryNCT02972892

Multi-site Anesthesia Randomized Controlled STudy of End Tidal Control Compared to Conventional Anesthesia Results

A study testing Conventional Fresh Gas in people with Et Control Performance in Adult Population Surgery, run by GE Healthcare at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Et Control Performance in Adult Population Surgery
What is being tested?: Conventional Fresh Gas
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 248 participants
Where: 4 sitesUnited States
Study dates: 9 Jun 2017to 5 Sep 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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.

Who cannot join

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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Emory University Hospital
Atlanta, Georgia, 30322
Duke University
Durham, North Carolina, 27710
University of Iowa Healthcare
Iowa City, Iowa, 52242
Loma Linda University
Loma Linda, California, 92354

Other trials in United States

About this study

Official title: 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).

Read the 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.

Conditions: Et Control Performance in Adult Population Surgery
Being tested: Et Control Feature, Conventional Fresh Gas

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT02972892
Study group	Role	What they receive
Et Control	Experimental	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. Receives: Device: Et Control Feature
Control Arm	Active comparator	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. Receives: Device: Conventional Fresh Gas

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Duration Without Large Deviation of End-Tidal Anesthetic Agent (EtAA) Based on Extraction Algorithm (ALG)
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.
Measured: Duration of each steady state, an average of approximately 60 minutes
Percent Duration Without Large Deviation of EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)
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.
Measured: Duration of each steady state, an average of approximately 60 minutes
Percent Duration Without Large Deviation of End-Tidal Oxygen (EtO2) Based on Extraction Algorithm (ALG)
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).
Measured: Duration of each steady state, an average of approximately 60 minutes
Percent Duration Without Large Deviation of EtO2 Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)
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)
Measured: Duration of each steady state, an average of approximately 60 minutes

Secondary outcomes (16)

Efficacy Response Time EtAA Based on Extraction Algorithm (ALG)
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).
Measured: Duration of each steady state, an average of approximately 60 minutes
Efficacy: Response Time for EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)
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).
Measured: Duration of each steady state, an average of approximately 60 minutes
Efficacy Response Time for EtO2 Based on Extraction Algorithm (ALG)
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).
Measured: 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)
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).
Measured: Duration of each steady state, an average of approximately 60 minutes
Efficacy: Settling Time for EtAA Based on the Extraction Algorithm (ALG)
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).
Measured: 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)
Settling time: time to achieve the desired EtAA steady state mean concentration. Values based on clinicians' or Investigators' recorded values (TGT).
Measured: Duration of each steady state, an average of approximately 60 minutes
Efficacy: Settling Time for EtO2 Based on the Extraction Algorithm (ALG)
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).
Measured: 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)
time to achieve the desired EtO2 steady state mean concentration. Values based on clinicians' or Investigators' recorded values (TGT).
Measured: Duration of each steady state, an average of approximately 60 minutes
Efficacy: Overshoot Amount of the Desired EtAA Based on Extraction Algorithm (ALG)
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).
Measured: 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)
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).
Measured: Duration of each steady state, an average of approximately 60 minutes
Efficacy: Overshoot Amount of Desired EtO2 Amount Based on the Extraction Algorithm (ALG)
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).
Measured: 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)
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).
Measured: 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)
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).
Measured: Duration of surgery, average of 112.1 minutes (+/- 78.7 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)
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).
Measured: Duration of Surgery
Accuracy of Et Control in Maintaining EtO2 Between User Set Target and Settling End Tidal Concentrations Based on the Extraction Algorithm (ALG)
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).
Measured: 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)
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).
Measured: Duration of surgery, average of 112.1 minutes (+/- 78.7 minutes)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Jun 20175 Sep 2018

First posted25 Nov 2016 (estimated)
Study start9 Jun 2017
Primary completion5 Sep 2018
Study completion5 Sep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Et Control Performance in Adult Population SurgeryStudies of the same condition, open and under way.
More trials run by GE HealthcareThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 248 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02972892
Sponsor's protocol ID: 123.07-2015-GES-0002
Status last verified: Oct 2022
First submitted: 14 Nov 2016
Last updated: 2 Nov 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: 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.

Publications

McCabe MD, Dear GL, Klopman MA, Garg K, Seering MS. End-Tidal Control Versus Manual Control of Inhalational Anesthesia Delivery: A Randomized Controlled Noninferiority Trial. Anesth Analg. 2024 Oct 1;139(4):812-820. doi: 10.1213/ANE.0000000000007132. Epub 2024 Jul 19.
PubMed 39028663

Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multi-site Anesthesia Randomized Controlled STudy of End Tidal Control (Et Control) Compared to Conventional Anesthesia Results (MASTER-Anesthesia Trial)
ClinicalTrials.gov ID: NCT02972892
Acronym / sponsor ID: 123.07-2015-GES-0002
Conditions: Et Control Performance in Adult Population Surgery
Study type: Interventional
Recruitment status: Completed
Enrolment: 248 participants (actual)
Lead sponsor: GE HealthcareIndustry (pharma, biotech, devices)
Study start: 9 Jun 2017 (actual)
Primary completion: 5 Sep 2018 (actual)
Study completion: 5 Sep 2018 (actual)
First posted: 25 Nov 2016 (estimated)
Results: Posted 2 Nov 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Et Control	Experimental	Device: Et Control FeatureSubjects, 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.
Control Arm	Active comparator	Device: Conventional Fresh GasSubjects, 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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:

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Et Control FeatureSubjects 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.	Device	Et Control
Conventional Fresh GasSubjects 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.	Device	Control Arm

Primary outcome

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 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 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)

16 secondary outcomes

Efficacy Response Time EtAA Based on Extraction Algorithm (ALG)
Time frame: Duration of each steady state, an average of approximately 60 minutes
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
Efficacy Response Time for EtO2 Based on Extraction Algorithm (ALG)
Time frame: 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)
Time frame: Duration of each steady state, an average of approximately 60 minutes
Efficacy: Settling Time for EtAA Based on the Extraction Algorithm (ALG)
Time frame: 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)
Time frame: Duration of each steady state, an average of approximately 60 minutes
Efficacy: Settling Time for EtO2 Based on the Extraction Algorithm (ALG)
Time frame: 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)
Time frame: Duration of each steady state, an average of approximately 60 minutes
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
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
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
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
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)
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
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 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)

Results and safety

Results posted to the registry on 2 Nov 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Et Control	110	101
Control Arm	118	116

Primary outcome: 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. Mean (Standard Deviation). Unit: percent duration

Measure	Et Control n = 110	Control Arm n = 118
Value	91.7 (10.82)	80.8 (17.93)

Et Control vs Control Arm: Mean Difference (Net): 10.9 (95% CI 6.89 to 15.01), p <.001, t-test, 2 sided

Population analysed: Intent-to-treat population includes all randomized subjects

Primary outcome: 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. Mean (Standard Deviation). Unit: percent duration

Measure	Et Control n = 110	Control Arm n = 118
Value	98.0 (2.05)	45.9 (31.45)

Et Control vs Control Arm: Mean Difference (Net): 52.1 (95% CI 46.25 to 57.95), p <.001, t-test, 2 sided

Population analysed: Intent-to-treat population includes all randomized subjects

Primary outcome: 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. Mean (Standard Deviation). Unit: percent duration

Measure	Et Control n = 110	Control Arm n = 118
Value	98.1 (2.76)	92.8 (14.38)

Et Control vs Control Arm: Mean Difference (Net): 5.3 (95% CI 2.64 to 8.04), p <.001, t-test, 2 sided

Population analysed: Intent-to-treat population includes all randomized subjects

Primary outcome: 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. Mean (Standard Deviation). Unit: percent duration

Measure	Et Control n = 110	Control Arm n = 118
Value	98.8 (1.49)	41.0 (40.65)

Et Control vs Control Arm: Mean Difference (Net): 44.5 (95% CI 35.56 to 53.41), p <.001, t-test, 2 sided

Population analysed: Intent-to-treat population includes all randomized subjects

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse even assessment was conducted from the time the subject provided consent to the end of the subject's participation in the study. Approximately 30 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Et Control	1 of 104 (1%)	36 of 104 (34.6%)	0 of 104
Control Arm	1 of 116 (0.9%)	43 of 116 (37.1%)	0 of 116

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39028663McCabe MD, Dear GL, Klopman MA, Garg K, Seering MS. End-Tidal Control Versus Manual Control of Inhalational Anesthesia Delivery: A Randomized Controlled Noninferiority Trial. Anesth Analg. 2024 Oct 1;139(4):812-820. doi: 10.1213/ANE.0000000000007132. Epub 2024 Jul 19.
Individual participant dataSharing planned: Yes. 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Melinda Seering, MD principal investigator

University of Iowa Healthcare

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Conventional Fresh Gas in people with Et Control Performance in Adult Population Surgery, run by GE Healthcare at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02972892, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.