18 and older, any sex, with Et Control Performance in Adult Population Surgery. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percent Duration Without Large Deviation of End-Tidal Anesthetic Agent (EtAA) Based on Extraction Algorithm (ALG)Primary· 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.
Group
Value
95% CI
Et Control
91.7
± 10.82
Control Arm
80.8
± 17.93
Percent Duration Without Large Deviation of EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)Primary· 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 th
Group
Value
95% CI
Et Control
98.0
± 2.05
Control Arm
45.9
± 31.45
Percent Duration Without Large Deviation of End-Tidal Oxygen (EtO2) Based on Extraction Algorithm (ALG)Primary· 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).
Group
Value
95% CI
Et Control
98.1
± 2.76
Control Arm
92.8
± 14.38
Percent Duration Without Large Deviation of EtO2 Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)Primary· 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)
Group
Value
95% CI
Et Control
98.8
± 1.49
Control Arm
41.0
± 40.65
Efficacy Response Time EtAA Based on Extraction Algorithm (ALG)Secondary· Duration of each steady state, an average of approximately 60 minutes
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).
Group
Value
95% CI
Et Control
73
± 174.1
Control Arm
196
± 378.3
Efficacy: Response Time for EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)Secondary· Duration of each steady state, an average of approximately 60 minutes
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).
Group
Value
95% CI
Et Control
23
± 40.9
Control Arm
196
± 455.0
Efficacy Response Time for EtO2 Based on Extraction Algorithm (ALG)Secondary· Duration of each steady state, an average of approximately 60 minutes.
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).
Group
Value
95% CI
Et Control
93
± 77.3
Control Arm
246
± 346.8
Efficacy: Response Time for EtO2 Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)Secondary· Duration of each steady state, an average of approximately 60 minutes
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).
Group
Value
95% CI
Et Control
129
± 451.7
Control Arm
406
± 727.8
Efficacy: Settling Time for EtAA Based on the Extraction Algorithm (ALG)Secondary· Duration of each steady state, an average of approximately 60 minutes
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).
Group
Value
95% CI
Et Control
105
± 181.9
Control Arm
165
± 186.4
Efficacy: Settling Time for EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)Secondary· Duration of each steady state, an average of approximately 60 minutes
Settling time: time to achieve the desired EtAA steady state mean concentration. Values based on clinicians' or Investigators' recorded values (TGT).
Group
Value
95% CI
Et Control
23
± 40.9
Control Arm
196
± 455.0
Efficacy: Settling Time for EtO2 Based on the Extraction Algorithm (ALG)Secondary· Duration of each steady state, an average of approximately 60 minutes
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).
Group
Value
95% CI
Et Control
123
± 117.5
Control Arm
235
± 213.2
Efficacy: Settling Time for EtO2 Based on Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT)Secondary· Duration of each steady state, an average of approximately 60 minutes
time to achieve the desired EtO2 steady state mean concentration. Values based on clinicians' or Investigators' recorded values (TGT).
Group
Value
95% CI
Et Control
167
± 121.1
Control Arm
815
± 1327.2
Adverse events — posted to ClinicalTrials.gov
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.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Et Control
Serious: 1/104 (1%)
Deaths: 0/104
Control Arm
Serious: 1/116 (1%)
Deaths: 0/116
Serious adverse events (2 terms)
Reaction
System
Et Control
Control Arm
Bile Leak
Hepatobiliary disorders
—
—
Vision Loss
Eye disorders
—
—
Other adverse events (40 terms — click to expand)
Reaction
System
Et Control
Control Arm
NIBP SBP>160 mmHg for >5 min
Vascular disorders
—
—
HR >110bpm more than 5 min
Cardiac disorders
—
—
NIBP MAP >120 mmHg for > 5 min
Vascular disorders
—
—
Nausea
Gastrointestinal disorders
—
—
Pain 8 of 10
Surgical and medical procedures
—
—
Hypotension (general)
Vascular disorders
—
—
NIPB MAP <55 mmHg for >5 min
Vascular disorders
—
—
Pain 7 out of 10
Surgical and medical procedures
—
—
HR <45bpm more than 5 min
Cardiac disorders
—
—
SpO2 < 90% for more than 5 min
Respiratory, thoracic and mediastinal disorders
—
—
NIBP SBP <70 mmHg for >5 min
Vascular disorders
—
—
Confusion
Nervous system disorders
—
—
Abdominal Cramps
Gastrointestinal disorders
—
—
Bladder Spasms
Renal and urinary disorders
—
—
Post-Operative Pain
Surgical and medical procedures
—
—
Inadvertent Cystotomy and Repair
Surgical and medical procedures
—
—
Post Operative Pain of 10
Surgical and medical procedures
—
—
Intraoperative Bleeding
Surgical and medical procedures
—
—
Intractable Pain
Surgical and medical procedures
—
—
Elevated Heart Rate and Breathing
Surgical and medical procedures
—
—
Bladder Wall Damage
Renal and urinary disorders
—
—
Left Thigh Weakness
Musculoskeletal and connective tissue disorders
—
—
Agitation
Psychiatric disorders
—
—
Emergence Delay
Surgical and medical procedures
—
—
Throat Pain
General disorders
—
—
Oral Pain
Surgical and medical procedures
—
—
Pain 9 of 10
Surgical and medical procedures
—
—
Intermittent Pain
Surgical and medical procedures
—
—
Vomiting
Gastrointestinal disorders
—
—
Dizziness
General disorders
—
—
Dizziness, photophobia, and delay in discharge from PACU
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).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GE Healthcare
Last refreshed: 2 November 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02972892.