Anesthetic Gas Consumption and Cost-EffectivenessNCT04851314
Comparison of Different Ventilator and Vaporizer Technologies to Study Economic and Environmental Implications
A study testing ICU certified ventilator and Non-ICU certified ventilator in people with Anesthetic Gas Consumption and Cost-Effectiveness, run by University of California, Irvine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthetic Gas Consumption and Cost-Effectiveness
- What is being tested?
- ICU certified ventilator and Non-ICU certified ventilator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2018to 8 Nov 2019
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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%
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine Medical Center
Orange, California, 92868
About this study
Official title: Low-flow Anesthesia: Cost-effectiveness of the FLOW-i Anesthesia Machine, a Comparison to Established Anesthesia Delivery Unit
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.
Read the 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.
- Being tested
- ICU certified ventilator, Non-ICU certified ventilator
- Keywords
- general anesthesia, anesthesia machines, sevoflurane, low volume ventilator, anesthetic costs, cost-effectiveness, fresh gas flow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICU certified ventilatorDevice
Examine anesthetic consumption rates
Non-ICU certified ventilatorDevice
Examine anesthetic consumption rates
| Study group | Role | What they receive |
|---|---|---|
| ICU certified ventilator | Active comparator | Participants assigned to receive ventilation with the ICU certified ventilator Receives: Device: ICU certified ventilator |
| Non-ICU certified ventilator | Active comparator | Participants assigned to receive ventilation with the Non-ICU certified ventilator Receives: Device: Non-ICU certified ventilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperative (minimum of 2 hours of anesthesia)
Secondary outcomes (2)
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.
Measured: Up to 24 hours
Time to Extubation From Weaning
Time it took to remove patient from mechanical ventilation
Measured: Intraoperative (minimum of 2 hours of anesthesia)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start14 Feb 2018
- Primary completion8 Nov 2019
- Study completion8 Nov 2019
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 (2)Papers the sponsor has linked to this study.
- Other trials for Anesthetic Gas Consumption and Cost-EffectivenessStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Ryan Field, University of California, Irvine
- Investigators
- Robert R Field, MD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04851314
- Sponsor's protocol ID
- UCIANES11 [HS# 2014-1248]
- Status last verified
- Jul 2021
- First submitted
- 30 Apr 2018
- Last updated
- 10 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 9728850Choi 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.
PubMed 21309477
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-flow Anesthesia: Cost-effectiveness of the FLOW-i Anesthesia Machine, a Comparison to Established Anesthesia Delivery Unit
- ClinicalTrials.gov ID
- NCT04851314
- Acronym / sponsor ID
- UCIANES11 [HS# 2014-1248]
- Keywords
- general anesthesia, anesthesia machines, sevoflurane, low volume ventilator, anesthetic costs, cost-effectiveness, fresh gas flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 8 Nov 2019 (actual)
- Study completion
- 8 Nov 2019 (actual)
- First posted
- 20 Apr 2021 (actual)
- Results
- Posted 10 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICU certified ventilator | Active comparator | Device: ICU certified ventilatorParticipants assigned to receive ventilation with the ICU certified ventilator |
| Non-ICU certified ventilator | Active comparator | Device: Non-ICU certified ventilatorParticipants assigned to receive ventilation with the Non-ICU certified ventilator |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Subjects under the age of 18
- Chronic Obstructive Pulmonary Disease (COPD)
- Body Mass Index (BMI) > 30
- ASA > 2
- Pregnant females
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 |
|---|---|---|
| ICU certified ventilatorExamine anesthetic consumption rates | Device | ICU certified ventilator |
| Non-ICU certified ventilatorExamine anesthetic consumption rates | Device | Non-ICU certified ventilator |
Primary outcome
Primary Study Variable: Amount of Gas Vaporized Anesthetic Per Minute Anesthesia
Time frame: Intraoperative (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.
2 secondary outcomes
Time to Reach Aldrete > 8
Time frame: Up to 24 hours
Time to Extubation From Weaning
Time frame: Intraoperative (minimum of 2 hours of anesthesia)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9728850Avramov 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.
- Background: PubMed 21309477Choi 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.
- Individual participant dataSharing planned: No
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.
Robert R Field, MD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICU certified ventilator and Non-ICU certified ventilator in people with Anesthetic Gas Consumption and Cost-Effectiveness, run by University of California, Irvine at 1 site 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 4 inclusion and 8 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 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 10 Aug 2021). 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?
Primary Study Variable: Amount of Gas Vaporized Anesthetic Per Minute Anesthesia (time frame: Intraoperative (minimum of 2 hours of anesthesia)). 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 NCT04851314, which also lists 2 linked publications.
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 10 Aug 2021.