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临床试验/NCT07534839
NCT07534839进行中(未招募)不适用

Evaluation of the Safety of Low-Flow Anesthesia Initiated Without Wash-in in Terms of Oxygenation and Depth of Anesthesia Using Arterial Blood Gas Analysis and EEG-Based PSI Monitoring

Erzincan Binali Yildirim Universitesi1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
60
试验地点
1
主要终点
Comparison of arterial oxygen partial pressure (PaO₂) values between groups

研究概览

简要总结

This study aims to evaluate whether adjusting the fresh gas flow rate to low-flow immediately after intubation, without performing a wash-in, is a reliable approach with respect to depth of anesthesia and oxygenation.

详细描述

Low-flow anesthesia is defined as the delivery of fresh gas flow at a rate of 0.5-1 L/min on the anesthesia machine . Due to its advantages such as reducing costs, decreasing environmental pollution related to anesthetic gases, preserving mucociliary activity, softening secretions, and reducing heat loss, it has attracted considerable attention from anesthesiologists in recent years. However, the main concerns involve maintaining adequate ventilation, ensuring sufficient tissue oxygen delivery, and achieving adequate depth of anesthesia. Therefore, additional monitoring is required for the safe application of low-flow techniques. Exhaled gas volume, airway pressure, fraction of inspired oxygen (FiO₂), volatile anesthetic agent concentration, carbon dioxide concentration, and peripheral oxygen saturation (SpO₂) should be closely monitored. Arterial blood gas sampling is the gold standard for monitoring oxygenation. The Patient State Index (PSI) is a processed EEG index derived from frontal EEG signals that numerically expresses the level of anesthesia/sedation on a scale from 0 to 100. PSI is generated based on spectral and coherence analyses of data obtained from four-channel EEG monitors such as Masimo SedLine®, using advanced artifact filtering, and was developed for objective monitoring of the level of consciousness during general anesthesia. PSI values between 25 and 50 generally indicate an adequate depth of anesthesia, whereas higher values suggest a reduction in anesthetic depth.

In low-flow anesthesia, after induction the patient is connected to mechanical ventilation, and the volatile agent is adjusted to 1 MAC with 50% O₂. Subsequently, wash-in is achieved by administering fresh gas flow at 4-6 L/min for approximately 10 minutes, after which the flow is reduced. However, some studies have reported that initiating anesthesia maintenance directly with low fresh gas flow, without performing wash-in, may also be a feasible approach.

To date, no study has evaluated the reliability of initiating low fresh gas flow during mechanical ventilation without performing wash-in, using arterial blood gas analysis and PSI monitoring. This study aimed to compare the reliability of techniques involving reduction of fresh gas flow using the traditional wash-in method versus without wash-in, in terms of hypoxia and depth of anesthesia, using serial arterial blood gas measurements and PSI monitoring.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA physical status I-II
  • Cases lasting longer than 30 minutes
  • Non-laparoscopic surgical procedures

排除标准

  • Patients with life-threatening renal, cardiac, or hepatic disease
  • Patients with chronic pulmonary diseases such as asthma or COPD
  • Patients with intraoperative hemodynamic instability
  • Patients with a body mass index (BMI) lower than 20 or higher than 30

研究组 & 干预措施

Group WI

No Intervention

In this group, after intubation, patients were ventilated for 10 minutes with 4 L/min fresh gas flow consisting of 2% sevoflurane and 60% O₂, after which the fresh gas flow rate was reduced to 0.75 L/min

Group WO

Active Comparator

In this group, after intubation, the fresh gas flow rate was set to 0.75 L/min with 60% O₂. The sevoflurane vaporizer was initially set to 8%, and the sevoflurane concentration was subsequently reduced according to the MAC value

干预措施: Initiation of low-flow anesthesia without wash-in following intubation (Device)

结局指标

主要结局

Comparison of arterial oxygen partial pressure (PaO₂) values between groups

时间窗: Measured at 10, 20, 30, and 45 minutes after induction of anesthesia and before the end of surgery.

Comparison of arterial oxygen partial pressure (PaO₂) and Patient State Index (PSI) values between groups.

Comparison of Patient State Index (PSI) values between groups.

时间窗: Continuously monitored intraoperatively and recorded at 10, 20, 30, and 45 minutes after induction of anesthesia.

PSI is an EEG-based index ranging from 0 to 100. Lower values indicate deeper anesthesia; the target range is 25-50 during general anesthesia.

次要结局

  • Mean alveolar concentration (MAC) values(Continuously monitored intraoperatively and recorded at 10, 20, 30, and 45 minutes after induction of anesthesia.)
  • Total sevoflurane consumption(From induction of anesthesia until the end of surgery (average duration approximately X minutes).)
  • Time to reach target MAC level(Time (minutes) from completion of endotracheal intubation to achievement of MAC 1.0, as measured on the anesthesia monitor)

研究者

发起方
Erzincan Binali Yildirim Universitesi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fazıl Ahmet Akbulut, MD

Principal Investigator

Erzincan Binali Yildirim University Mengucek Gazi Training and Research Hospital

研究点 (1)

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