N/A
N=228
Multi-site Anesthesia Randomized Controlled STudy of End Tidal Control Compared to Conventional Anesthesia Results
Et Control Performance in Adult Population Surgery
Bottom Line
View on ClinicalTrials.gov: NCT02972892 ↗Enrolled (actual)
228
Serious AEs
0.9%
Results posted
Nov 2022
Primary outcome: Primary: Percent Duration Without Large Deviation of End-Tidal Anesthetic Agent (EtAA) Based on Extraction Algorithm (ALG) — 91.7; 80.8 percent duration — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Et Control Feature (Device); Conventional Fresh Gas (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GE Healthcare
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Duration Without Large Deviation of End-Tidal Anesthetic Agent (EtAA) Based on Extraction Algorithm (ALG) |
91.7; 80.8 | <.001 sig |
| PRIMARY Percent Duration Without Large Deviation of EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) |
98.0; 45.9 | <.001 sig |
| PRIMARY Percent Duration Without Large Deviation of End-Tidal Oxygen (EtO2) Based on Extraction Algorithm (ALG) |
98.1; 92.8 | <.001 sig |
| PRIMARY Percent Duration Without Large Deviation of EtO2 Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) |
98.8; 41.0 | <.001 sig |
| SECONDARY Efficacy Response Time EtAA Based on Extraction Algorithm (ALG) |
73; 196 | — |
| SECONDARY Efficacy: Response Time for EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) |
23; 196 | — |
| SECONDARY Efficacy Response Time for EtO2 Based on Extraction Algorithm (ALG) |
93; 246 | — |
| SECONDARY Efficacy: Response Time for EtO2 Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) |
129; 406 | — |
| SECONDARY Efficacy: Settling Time for EtAA Based on the Extraction Algorithm (ALG) |
105; 165 | — |
| SECONDARY Efficacy: Settling Time for EtAA Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) |
23; 196 | — |
| SECONDARY Efficacy: Settling Time for EtO2 Based on the Extraction Algorithm (ALG) |
123; 235 | — |
| SECONDARY Efficacy: Settling Time for EtO2 Based on Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) |
167; 815 | — |
| SECONDARY Efficacy: Overshoot Amount of the Desired EtAA Based on Extraction Algorithm (ALG) |
8.85; 6.54 | — |
| SECONDARY Efficacy: Overshoot Amount of the Desired EtAA Amount Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) |
5.28; 12.09 | — |
| SECONDARY Efficacy: Overshoot Amount of Desired EtO2 Amount Based on the Extraction Algorithm (ALG) |
3.47; 2.80 | — |
| SECONDARY Efficacy: Overshoot Amount of Desired EtO2 Amount Based on Clinician's or Investigators' Recorded Target Values of Anesthetic Agent and Oxygen (TGT) |
2.14; 11.13 | — |
| SECONDARY Accuracy of Et Control in Maintaining EtAA Control Between User Set Target and Settling End Tidal Concentrations Based on the Extraction Algorithm (ALG) |
0.11; 0.04; 0.04; 0.05 | — |
| SECONDARY 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) |
0.10; 0.03; 0.04; 0.05 | — |
| SECONDARY Accuracy of Et Control in Maintaining EtO2 Between User Set Target and Settling End Tidal Concentrations Based on the Extraction Algorithm (ALG) |
0.57; 0.62; 0.64; 0.62 | — |
| SECONDARY 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) |
0.62; 0.61; 0.64; 0.63 | — |
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).
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.
Data sourced from ClinicalTrials.gov (NCT02972892). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.