Low-flow Anesthesia: Cost-effectiveness of the FLOW-i Anesthesia Machine, a Comparison to Established Anesthesia Delivery Unit
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Primary Study Variable: Amount of Gas Vaporized Anesthetic Per Minute Anesthesia
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •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%
Arms & Interventions
ICU certified ventilator
Participants assigned to receive ventilation with the ICU certified ventilator
Intervention: ICU certified ventilator (Device)
Non-ICU certified ventilator
Participants assigned to receive ventilation with the Non-ICU certified ventilator
Intervention: Non-ICU certified ventilator (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Time to Reach Aldrete > 8(Up to 24 hours)
- Time to Extubation From Weaning(Intraoperative (minimum of 2 hours of anesthesia))
Investigators
Robert Ryan Field
HS/Assistant Clinical Professor; Neuroanesthesiology Clinical Director
University of California, Irvine