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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICU certified ventilator | Active Comparator | Participants assigned to receive ventilation with the ICU certified ventilator |
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| Non-ICU certified ventilator | Active Comparator | Participants assigned to receive ventilation with the Non-ICU certified ventilator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICU certified ventilator | Device | Examine anesthetic consumption rates |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Intraoperative (minimum of 2 hours of anesthesia) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert R Field, MD | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Irvine Medical Center | Orange | California | 92868 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9728850 | Background | Avramov MN, Griffin JD, White PF. The effect of fresh gas flow and anesthetic technique on the ability to control acute hemodynamic responses during surgery. Anesth Analg. 1998 Sep;87(3):666-70. doi: 10.1097/00000539-199809000-00033. | |
| 21309477 | Background | Choi SU, Shin HW, Jung HI, Park JY, Yoon SZ, Lee YS, Kim WY, Chang SH. Control of the haemodynamic response to surgical stimuli in semi-closed circuit or closed circuit anaesthesia using a multifunctional anaesthesia system. J Int Med Res. 2010 Sep-Oct;38(5):1637-44. doi: 10.1177/147323001003800508. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Maquet Flow-i C20 | Subjects receiving the Maquet Flow-i C20 anesthetic delivery machine will undergo standardized anesthetic protocol to evaluate anesthetic consumption rates |
| FG001 | GE Aisys CS2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 5, 2018 |
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| Non-ICU certified ventilator |
| Device |
Examine anesthetic consumption rates |
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| Up to 24 hours |
| Time to Extubation From Weaning | Time it took to remove patient from mechanical ventilation | Intraoperative (minimum of 2 hours of anesthesia) |
Subjects receiving the GE Aisys CS2 anesthetic delivery machine will undergo standardized anesthetic protocol to evaluate anesthetic consumption rates
| COMPLETED |
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| NOT COMPLETED |
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Completed population only
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| ID | Title | Description |
|---|---|---|
| BG000 | Maquet Flow-i C20 | Subjects receiving the Maquet Flow-i C20 anesthetic delivery machine will undergo standardized anesthetic protocol to evaluate anesthetic consumption rates. |
| BG001 | GE Aisys CS2 | Subjects receiving the GE Aisys CS2 anesthetic delivery machine will undergo standardized anesthetic protocol to evaluate anesthetic consumption rates. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Completed patient population for each ventilator type | Posted | Mean | Standard Deviation | grams/minute | Intraoperative (minimum of 2 hours of anesthesia) |
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| 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. | same as primary outcome measure | Posted | Mean | Standard Deviation | minutes | Up to 24 hours |
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| Secondary | Time to Extubation From Weaning | Time it took to remove patient from mechanical ventilation | same as primary outcome | Posted | Mean | Standard Deviation | minutes | Intraoperative (minimum of 2 hours of anesthesia) |
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Through study completion, approximately 24 hours
As study did not deviate from the standard of care in use of FDA approved devices, any possible adverse event and/or serious adverse event would be the same standard of care.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Maquet Flow-i C20 | Subjects receiving the Maquet Flow-i C20 anesthetic delivery machine will undergo standardized anesthetic protocol to evaluate anesthetic consumption rates | 0 | 52 | 0 | 52 | 0 | 52 |
| EG001 | GE Aisys CS2 | Subjects receiving the GE Aisys CS2 anesthetic delivery machine will undergo standardized anesthetic protocol to evaluate anesthetic consumption rates | 0 | 51 | 0 | 51 | 0 | 51 |
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Some overall limitations include include, but are not limited to: a small overall sample size, fluctuations in the concentration of volatile agent setting or fresh gas flow (due to positioning during surgical preparation), and variations in time precision provider charting of the secondary endpoints (weaning, gas off, time in recovery, recovery criteria completion). Protocol procedures were standardized, however lack of blinding is something the authors could not feasibly account for.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Ryan Field | UC Irvine Health | 7145065703 | fieldr@uci.edu |
| Jun 21, 2021 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 5, 2018 | Jun 21, 2021 | ICF_001.pdf |
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