Accuracy of the MAAS Method (Minimal-flow Auto-control Anesthesia System) for the Administration of Desflurane and Sevoflurane in the Anesthetic Maintenance Phase. Prospective and Paired Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Changes made in the sevoflurane vaporizer
研究概览
简要总结
In the present work the investigators will study the accuracy of the MAAS (Minimal-flow Autocontrol Anesthesia System) method to estimate the percentage of halogenated anesthetic (HA) to be supplied to the anesthetic circuit based on the estimation of HA uptake during the maintenance phase. The investigators will evaluate the accuracy of sevoflurane and desflurane vaporizers to guarantee the administration of that amount of estimated HA, thus guaranteeing the maintenance of the target concentration of HA at the end of expiration: end-tidal target HA% (ettHA%). To do this, the investigators will quantify the number of adjustments that need to be made to each vaporizer to maintain ettHA%. As secondary objectives, the investigators will analyze the time to reach the target concentration of HA, the deviations that occur from that concentration despite the correct application of the method, and the consumption of HA during the procedure.
Through the entire procedure, all participants will be ventilated under a tailored open lung approach (tOLA) strategy.
详细描述
Halogenated anesthetics (HAs) are the gaseous drugs commonly used in inhalation anesthesia to ensure, among other effects, loss of consciousness or induction of "anesthetic sleep". They are administered in their gaseous state through the anesthesia vaporizers inserted in the anesthesia workstations. Like other gaseous hydrocarbons, HAs contribute to global warming, with the particularity that their global warming potential (GWP) is hundreds of times higher than that of the reference molecule, CO2, especially in the case of desflurane. For this reason, professionals and administrations must be especially sensitive when handling this type of drugs. Indeed, the investigators consider that its use should be questioned in the absence of administration devices capable of minimizing atmospheric emissions, provided that there are adequate therapeutic alternatives.
Currently, there are "universally" available tools that guarantee that these minimum contamination principles can be met in daily practice. The fundamental tool would be the anesthesia circle breathing circuit. Circle circuits are conceived as artificial breathing systems that allow the rebreathing of exhaled gases. Rebreathing exhaled gases, once the CO2 has been removed by means of gas neutralization systems incorporated in anesthesia stations (CO2 absorbers), is safe and effective, and today this mode of administration of the inhalation anesthesia has become the gold standard. The usefulness and efficiency of circle circuits is anesthesiologist-dependent, since the reuse of exhaled gases will depend on the amount of "new" (fresh) medicinal gases that the anesthesiologist allows to enter the anesthesia workstation every minute, by means of the regulation of the fresh gas flow (FGF): the higher FGF, the less reuse of exhaled gases and at the greater surplus of "waste" gases to be evacuated and expelled into the atmosphere. On the contrary, the fewer new gases the anesthesiologist allows to enter the anesthesia workstation, the greater the reuse of exhaled gases, and the smaller the volume of gases expelled into the atmosphere. The administration of inhalation anesthesia through the use of low FGF, known as low flow anesthesia (LFA) techniques, would therefore constitute one of the main contributors to the reduction of HA emissions into the atmosphere.
The majority of anesthesia workstations used in daily practice allow anesthesiologists to work with FGF lower than 500 milliliters per minute (ml/min) or reaching to the closed-circuit anesthesia mode, that modality of inhalation anesthesia in which it is supplied to the system (anesthesia workstation and patient) the amount of gases (ml/min) that are transferred ("lost") from the central compartment (blood and highly perfused organs- HPO) to other compartments due to the principle of partial pressures equilibrium between different compartments (uptake phenomenon by muscle and fat), or metabolic consumption in the case of O2.
Different techniques for administering LFA have been described. The MAAS method (Minimal-flow Autocontrol Anesthesia System) proposes a didactic and easy way to estimate the needs for HA supplementation during the anesthetic maintenance phase, and includes a feasible formulation when adjusting the supply of HA to the system. The maintenance phase would comprise from the moment in which the target concentration of HA in the central compartment is reached, until the moment in which HA stops being administered to the system. During this period, HA keeps on being transferred towards muscle and fat from the central compartment (highly perfused organs (HPO) compartment) following the principle of partial pressures equilibrium. The estimation of HA uptake (HAup) by muscle and fat once the equilibrium state between the anesthesia workstation (respiratory circuit) and the HPO is reached, is based on the calculation HAup (ml/min) =HAfi-HAfe*MV(ml/min), where HAfi and HAfe state for inspired and expired fraction of HA, respectively; and MV for volume minute.
The estimate of the ml of HA to be supplied to the anesthetic circuit through the FGF, would be done following the formula HAdel (from HA delivered)= HAup (ml/min )*100% /FGF(ml).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects (≥ 18 years) scheduled for robotic urological, coloproctological or gynecological surgery in the investigators´ institution
- •Written informed consent
排除标准
- •Participation in another interventional study
- •Participants unable to understand the information contained in the informed consent
- •American Society of Anesthesiologists (ASA) classification grade = IV
- •Patient in dialysis
- •Chronic obstructive pulmonary disease (COPD) grade Global Initiative for Chronic Obstructive Lung Disease(GOLD) > 2
- •Functional vital capacity < 60% or > 120% of the predicted
- •Body mass index (BMI) > 35 kg/m2
- •New York Heart Association (NYHA) functional class ≥ 3
- •Clinically suspected heart failure
- •Diagnosis or suspicion of intracranial hypertension
- •Presence of pneumothorax or giant bullae on preoperative imaging tests
- •Use of Continuous Positive Airway Pressure (CPAP).
结局指标
主要结局
Changes made in the sevoflurane vaporizer
时间窗: 60 minutes, starting from the end of Phase sevo 1 (once filled the HPO compartment)
Number of adjustments that must be made in the sevoflurane vaporizer to maintain the predefined end-tidal target of sevoflurane (ettSEVO%).
Changes made in the desflurane vaporizer
时间窗: 60 minutes, starting from the end of Phase desflu 1(once filled the HPO compartment)
Number of adjustments that must be made in the desflurane vaporizer to maintain the predefined end-tidal target of desflurane (ettDESFLU%).
次要结局
- Time to reach the ettSEVO%(Immediately after OTI and until completing the Phase sevo 1)
- Deviations from ettDESFLU% despite the correct application of the method(60 minutes: starting from the end of Phase desflu1 until the end of Phase desflu 2)
- Deviations from ettSEVO% despite the correct application of the method(60 minutes: starting from the end of Phase sevo 1 until the end of Phase sevo 2)
- Time to reach the ettDESFLU%(Immediately after completing the Washout phase and until completing the Phase desflu 1.)
- Consumption of HA (ml of HA in its liquid phase) during the procedure(During the procedure: starting pre-intervention and immediately after the procedure)
