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Comparison of Different Ventilator and Vaporizer Technologies to Study Economic and Environmental Implications

Low-flow Anesthesia: Cost-effectiveness of the FLOW-i Anesthesia Machine, a Comparison to Established Anesthesia Delivery Unit

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04851314
Enrollment
110
Registered
2021-04-20
Start date
2018-02-14
Completion date
2019-11-08
Last updated
2021-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthetic Gas Consumption and Cost-Effectiveness

Keywords

general anesthesia, anesthesia machines, sevoflurane, low volume ventilator, anesthetic costs, cost-effectiveness, fresh gas flow

Brief summary

The purpose of this study is to test whether or not the use of a low volume ventilator in an anesthesia machine reduces anesthetic costs significantly as compared to other high volume machines. The study will compare the a low-flow anesthesia machine to a traditional anesthesia machine during routine elective general surgery in patients with ASA ratings of 1-2 under general anesthesia receiving standard care.

Detailed description

The study member will screen for potential subjects using the UCIMC surgical schedule. If a subject is deemed ineligible based on the inclusion and exclusion criteria after reviewing the medical history, his/her record will be discarded. No records will be retained from ineligible subjects. After discussing with the patient's surgeon, study team member will initiate the informed consent process by approaching each eligible subject to explain the study and what it entails. The Lead Researcher will address all questions and concerns from the subject before asking the subject to sign the research consent form. The GE anesthesia machines currently owned by the operating room will be used to serve as the comparator to the Flow-i machine. The high volume anesthesia machines do not use a low volume system. Subjects will be randomized by recruitment day. On a given recruitment day, all consented subjects will receive anesthesia from one of two groups: (1) MAQUET FLOW-i device (2) GE anesthetic device Time points for both groups include: T0: Time of intubation, when volatile anesthetic are typically first delivered to the patient. We will use 15L/min fresh gas flow, while dictating tidal volumes of 6-8 mL/kg ideal body weight and a PEEP of 6 centimeters of water (cm H2O) in accordance with current best practices. T1: Time of incision, which typically represents the time of reaching steady state conditions of volatile anesthetic delivery. We will reduce fresh gas flow to 2 L/min in accordance with local practice and weigh the vaporizer at this point, allowing us to measure comparative anesthetic consumption during this wash-in time period (T0-T1). T2: Time of anesthetic weaning, typically the time when preparing for patient emergence begins by discontinuing the delivery of volatile anesthetics to the patient. The vaporizer will be re- weighed at this point, allowing us to measure comparative anesthetic consumption at steady state maintenance of anesthetic depth (T1-T2) Logically, we will also be able to use T0-T2 in order to understand total comparative anesthetic consumption. Aside from the randomization to either Group 1 or Group 2, there will be no changes in the surgical or anesthetic procedure, including the medication or treatments given to the subjects as determined by the treating physician. All subjects will receive general anesthesia in accordance to local practice. For this study, the vaporizer(s) will be weighed on a tared scale before research procedures commence, after induction, and when the gas is shut off during weaning of anesthesia in preparation for extubation to calculate the amount consumed during this time (grams/minute). In addition, the following variables will be recorded: Subject weight (kg) Tidal Volume (TV) Respiratory Rate (RR) 9 of 24 Positive end-expiratory pressure (PEEP) Fresh Gas Flow Volume % gas End Tidal (%) Time of extubation Time when Aldrete score \> 8 This is not a physician-blinded study being that the physical characteristics of the standard delivery units are distinguishable from the MAQUET FLOW-i machine. All MAC concentrations are standard of care: After the surgical procedure, patient will be assessed for time to reach Aldrete score greater than 8, level of pain and time to extubation. Their medical records will be reviewed to determine need for times and adverse events. Patients will not be contacted for study-related follow-up after they are discharged from recovery. No photographs or audio/video recording will be collected for this study. Subject's Privacy: The study team member will screen for potential subjects using the UCIMC surgical schedule. If a subject is deemed ineligible based on the inclusion and exclusion criteria after reviewing the medical history, his/her record will be discarded. No records will be retained from ineligible subjects. Study team member will approach each eligible patient to explain the study and what it entails. The study team member will address all questions and concerns from the subjects before asking the patient to sign the research consent form.

Interventions

DEVICEICU certified ventilator

Examine anesthetic consumption rates

DEVICENon-ICU certified ventilator

Examine anesthetic consumption rates

Sponsors

University of California, Irvine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Age 18-65 years * Undergo surgery under general anesthesia in UCI Medical Center * Agree to sign the consent and HIPAA forms * Subjects who are able to receive sevoflurane

Exclusion criteria

* Subjects under the age of 18 * Chronic Obstructive Pulmonary Disease (COPD) * Body Mass Index (BMI) \> 30 * ASA \> 2 * Pregnant females * Procedures less than 2 hours * Those with known sensitivity to sevoflurane or other halogenated agents; those with known or suspected susceptibility to malignant hyperthermia * Severe Cardiovascular Disease: Left Ventricular Ejection Fraction (LVEF) \< 30%

Design outcomes

Primary

MeasureTime frameDescription
Primary Study Variable: Amount of Gas Vaporized Anesthetic Per Minute AnesthesiaIntraoperative (minimum of 2 hours of anesthesia)The purpose of this study is to test whether or not the use of a low volume ventilator in an anesthesia machine reduces anesthetic costs significantly as compared to other high volume machines. The study will compare the FLOW-i anesthesia machine to a GE anesthesia machine during routine elective general surgery in patients with ASA ratings of 1-2 under general anesthesia receiving standard care.

Secondary

MeasureTime frameDescription
Time to Reach Aldrete > 8Up to 24 hoursTime it took for patient to be safely discharged from the post-anesthesia care unit (PACU). The Aldrete Score evaluates recovery after anesthesia and patient readiness to be discharged from PACU. The patient is assessed for consciousness, mobility, breathing, circulation, and color. The evaluation occurs immediately after surgery and then every (1) hour before the patient is deemed ready for discharge.
Time to Extubation From WeaningIntraoperative (minimum of 2 hours of anesthesia)Time it took to remove patient from mechanical ventilation

Countries

United States

Participant flow

Pre-assignment details

Some enrolled subjects were excluded due to unforeseen circumstances in the clinical workflow e.g. a change in anesthetic preference or canceled surgery. Data from these cases could not provide meaningful results for analysis.

Participants by arm

ArmCount
Maquet Flow-i C20
Subjects receiving the Maquet Flow-i C20 anesthetic delivery machine will undergo standardized anesthetic protocol to evaluate anesthetic consumption rates.
52
GE Aisys CS2
Subjects receiving the GE Aisys CS2 anesthetic delivery machine will undergo standardized anesthetic protocol to evaluate anesthetic consumption rates.
51
Total103

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyChange in Anesthesia Plan (patient no longer meets inclusion criteria)32
Overall StudyUnable to complete research set-up procedures02

Baseline characteristics

CharacteristicMaquet Flow-i C20GE Aisys CS2Total
Age, Continuous42 years
STANDARD_DEVIATION 14
44 years
STANDARD_DEVIATION 13
43 years
STANDARD_DEVIATION 13
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
35 Participants29 Participants64 Participants
Sex: Female, Male
Male
17 Participants22 Participants39 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 520 / 51
other
Total, other adverse events
0 / 520 / 51
serious
Total, serious adverse events
0 / 520 / 51

Outcome results

Primary

Primary Study Variable: Amount of Gas Vaporized Anesthetic Per Minute Anesthesia

The purpose of this study is to test whether or not the use of a low volume ventilator in an anesthesia machine reduces anesthetic costs significantly as compared to other high volume machines. The study will compare the FLOW-i anesthesia machine to a GE anesthesia machine during routine elective general surgery in patients with ASA ratings of 1-2 under general anesthesia receiving standard care.

Time frame: Intraoperative (minimum of 2 hours of anesthesia)

Population: Completed patient population for each ventilator type

ArmMeasureValue (MEAN)Dispersion
Maquet Flow-i C20Primary Study Variable: Amount of Gas Vaporized Anesthetic Per Minute Anesthesia95.48 grams/minuteStandard Deviation 49.29
GE Aisys CS2Primary Study Variable: Amount of Gas Vaporized Anesthetic Per Minute Anesthesia119.3 grams/minuteStandard Deviation 62.22
Secondary

Time to Extubation From Weaning

Time it took to remove patient from mechanical ventilation

Time frame: Intraoperative (minimum of 2 hours of anesthesia)

Population: same as primary outcome

ArmMeasureValue (MEAN)Dispersion
Maquet Flow-i C20Time to Extubation From Weaning10.37 minutesStandard Deviation 6.321
GE Aisys CS2Time to Extubation From Weaning10.78 minutesStandard Deviation 6.413
Secondary

Time to Reach Aldrete > 8

Time it took for patient to be safely discharged from the post-anesthesia care unit (PACU). The Aldrete Score evaluates recovery after anesthesia and patient readiness to be discharged from PACU. The patient is assessed for consciousness, mobility, breathing, circulation, and color. The evaluation occurs immediately after surgery and then every (1) hour before the patient is deemed ready for discharge.

Time frame: Up to 24 hours

Population: same as primary outcome measure

ArmMeasureValue (MEAN)Dispersion
Maquet Flow-i C20Time to Reach Aldrete > 898.13 minutesStandard Deviation 51.83
GE Aisys CS2Time to Reach Aldrete > 889.18 minutesStandard Deviation 52.09

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026