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Manual Versus Autoflow Ventilation During Anesthesia Inductıon in Geriatric Patients

2026年5月13日 更新者:Fatma GÜLGÜN KILIÇASLAN、Ankara City Hospital Bilkent

Effects of Manual Versus Autoflow Ventilation During Anesthesia Induction on Cerebral and Peripheral Oxygenation in Geriatric Patients

The objective of this study is to compare the effects of manual ventilation and AutoFlow ventilation, administered during the induction of general anesthesia, on cerebral (s-rSO₂) and peripheral (somatic) oxygenation (p-rSO₂) in geriatric patients.

研究概览

详细说明

Ventilation strategies applied during the induction of general anesthesia have a significant impact on cerebral and peripheral oxygenation in geriatric patients. During the induction phase, respiratory and hemodynamic changes become more pronounced due to age-related physiological alterations such as diminished cardiopulmonary reserve, increased chest wall rigidity, decreased pulmonary elasticity, and impaired cerebral autoregulation. These changes increase the vulnerability of elderly patients to hypoxemia, hypocapnia, and imbalances in oxygen delivery. In particular, even brief episodes of hypoxemia or hypocapnia during induction may adversely affect cerebral oxygenation in this population.

Manual mask ventilation may result in unintentional hyperventilation or hypoventilation, potentially leading to hypocapnia and subsequent disturbances in cerebral oxygenation. In contrast, AutoFlow ventilation provides controlled ventilation with predefined parameters and may ensure more stable oxygen delivery.

This study is designed as a prospective, single-center, randomized controlled trial to compare the effects of manual ventilation and AutoFlow ventilation applied during the induction of general anesthesia on cerebral regional oxygen saturation (s-rSO₂) and peripheral (somatic) regional oxygen saturation (p-rSO₂) in geriatric patients. The primary hypothesis is that AutoFlow ventilation provides more stable cerebral and peripheral oxygenation compared to manual ventilation during the induction period.

The study will be conducted in the General and Oncology Operating Rooms of Ankara Bilkent City Hospital. Patients aged 65 years and older, of both sexes, classified as American Society of Anesthesiologists (ASA) physical status I-III, and scheduled for elective surgery requiring endotracheal intubation under general anesthesia will be included. A total of 106 patients (53 per group) will be enrolled based on power analysis, accounting for a potential 10% data loss.

Upon arrival in the operating room following standard preoperative fasting, demographic data (age, sex, height, weight, body mass index) and clinical characteristics (comorbidities, ASA classification) will be recorded. Standard ASA monitoring, including electrocardiography, non-invasive blood pressure, and pulse oximetry, will be applied. Cerebral and peripheral oxygenation will be continuously monitored using near-infrared spectroscopy (NIRS) with sensors placed bilaterally on the frontal region and on the volar surface of the forearms. Baseline values will be recorded before preoxygenation (T1).

Preoxygenation will be performed using 100% oxygen with a flow rate of 10 L/min until end-tidal oxygen (ETO₂) reaches 85% and plateaus for at least 30 seconds. Measurements at this stage will be recorded as T2.

Anesthesia induction will be standardized using fentanyl (1 µg/kg), lidocaine (1 mg/kg), propofol (2-3 mg/kg), and rocuronium (0.6-1 mg/kg), while maintaining hemodynamic stability within ±20% of baseline values. Following induction, mask ventilation with 100% oxygen will be applied for 2 minutes.

Patients will be randomly assigned using a computer-based block randomization method into two groups: manual ventilation and AutoFlow ventilation. In the manual ventilation group, ventilation will be performed by an experienced anesthesiologist or anesthesia resident using a reservoir bag. In the AutoFlow group, ventilation will be delivered by the anesthesia machine using predefined settings: tidal volume of 6 mL/kg (ideal body weight), respiratory rate of 12 breaths per minute, peak pressure limit of 30 cmH₂O, and positive end-expiratory pressure (PEEP) of 5 cmH₂O.

At the end of the 2-minute ventilation period before laryngoscopy, measurements will be recorded as T3 (post-induction, pre-intubation), including heart rate, mean arterial pressure, s-rSO₂, p-rSO₂, end-tidal carbon dioxide (EtCO₂), and peak inspiratory pressure (PIP). After endotracheal intubation and confirmation of tube placement, mechanical ventilation will be initiated and final measurements will be recorded as T4 (post-intubation).

To ensure standardization, NIRS device settings, including alarm limits, noise-reduction filters, and averaging time (8 seconds), will be kept constant for all patients. Factors that may affect measurements, such as motion artifacts, extremity temperature, arrhythmias, or vasopressor use, will be recorded.

研究类型

介入性

注册 (估计的)

106

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Çankaya
      • Ankara、Çankaya、土耳其(türkiye)、06800
        • 招聘中
        • Ankara Bilkent City Hospital Department of Anesthesiology and Reanimation

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Patients aged 65 years and older.
  • Patients scheduled to undergo elective surgery requiring endotracheal intubation under general anesthesia.
  • Patients with an American Society of Anesthesiologists (ASA) physical status of I, II, or III.
  • Volunteer patients who are willing to participate and provide written informed consent.

Exclusion Criteria:

  • Patients with severe heart failure or severe pulmonary disease.
  • Patients with a presence or history of brain tumors or cerebrovascular accidents (CVA/stroke).
  • Patients with impaired cooperation or cognitive dysfunction (e.g., dementia, delirium, Alzheimer's disease).
  • Patients with a known history or preoperative prediction of a difficult airway.
  • Patients with a known allergy to the monitoring sensor materials.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:Group M (Manual Ventilation)
Following the standardized induction of general anesthesia (1 µg/kg fentanyl, 1 mg/kg lidocaine, 2-3 mg/kg propofol, and 0.6-1 mg/kg rocuronium), mask ventilation with 100% oxygen will be manually performed by an experienced anesthesiologist or anesthesia resident. Manual ventilation using a reservoir bag will be maintained for 2 minutes to allow for adequate muscle relaxation prior to intubation.
Patients will receive manual mask ventilation with 100% oxygen using a reservoir bag. This procedure will be performed by an experienced anesthesiologist or anesthesia resident for 2 minutes following the administration of induction agents, allowing for adequate muscle relaxation prior to endotracheal intubation.
实验性的:Group A (AutoFlow Ventilation)
Following the same standardized general anesthesia induction protocol, mask ventilation with 100% oxygen will be mechanically delivered by the anesthesia workstation for 2 minutes. The device will be set to deliver a tidal volume (VT) of 6 mL/kg based on the patient's ideal body weight, a respiratory rate of 12 breaths/minute, a peak inspiratory pressure limit of 30 cmH₂O, and a Positive End-Expiratory Pressure (PEEP) of 5 cmH₂O.
Patients will receive mask ventilation delivered mechanically by the anesthesia workstation. The device will provide 100% oxygen for 2 minutes following the administration of induction agents. The ventilator settings will be standardized to an AutoFlow mode with a tidal volume (VT) of 6 mL/kg (based on ideal body weight), a respiratory rate of 12 breaths/minute, a peak pressure limit of 30 cmH₂O, and a Positive End-Expiratory Pressure (PEEP) of 5 cmH₂O

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Cerebral Regional Oxygen Saturation (s-rSO2)
大体时间:Baseline prior to pre-oxygenation (T1), immediately after pre-oxygenation (T2), post-induction/pre-intubation following 2 minutes of mask ventilation (T3), and immediately post-intubation (T4).
Bilateral cerebral regional oxygen saturation will be continuously measured using a Near-Infrared Spectroscopy (NIRS) device (INVOS™ oximeter) with sensors placed on the right and left frontal regions. The changes in s-rSO2 values will be recorded to evaluate the impact of manual versus AutoFlow mask ventilation during the induction of general anesthesia.
Baseline prior to pre-oxygenation (T1), immediately after pre-oxygenation (T2), post-induction/pre-intubation following 2 minutes of mask ventilation (T3), and immediately post-intubation (T4).

次要结果测量

结果测量
措施说明
大体时间
Change in Peripheral (Somatic) Regional Oxygen Saturation (p-rSO2)
大体时间:Baseline prior to pre-oxygenation (T1), immediately after pre-oxygenation (T2), post-induction/pre-intubation following 2 minutes of mask ventilation (T3), and immediately post-intubation (T4).
Bilateral peripheral regional oxygen saturation will be measured using NIRS sensors placed on the volar surfaces of the right and left forearms to evaluate tissue oxygen delivery and peripheral perfusion.
Baseline prior to pre-oxygenation (T1), immediately after pre-oxygenation (T2), post-induction/pre-intubation following 2 minutes of mask ventilation (T3), and immediately post-intubation (T4).
Mean Arterial Pressure (MAP)
大体时间:Baseline prior to pre-oxygenation (T1), immediately after pre-oxygenation (T2), post-induction/pre-intubation following 2 minutes of mask ventilation (T3), and immediately post-intubation (T4).
Hemodynamic stability will be evaluated by recording Mean Arterial Pressure (MAP) using standard non-invasive monitor. Measurements will be tracked to ensure parameters remain within a ±20% margin of the baseline during induction.
Baseline prior to pre-oxygenation (T1), immediately after pre-oxygenation (T2), post-induction/pre-intubation following 2 minutes of mask ventilation (T3), and immediately post-intubation (T4).
Peripheral Oxygen Saturation (SpO2)
大体时间:Baseline prior to pre-oxygenation (T1), immediately after pre-oxygenation (T2), post-induction/pre-intubation following 2 minutes of mask ventilation (T3), and immediately post-intubation (T4).
Standard systemic oxygen saturation will be monitored non-invasively via pulse oximetry.
Baseline prior to pre-oxygenation (T1), immediately after pre-oxygenation (T2), post-induction/pre-intubation following 2 minutes of mask ventilation (T3), and immediately post-intubation (T4).
End-Tidal Carbon Dioxide (EtCO2)
大体时间:Post-induction/pre-intubation following 2 minutes of mask ventilation (T3), and immediately post-intubation (T4).
The efficacy of the mask ventilation techniques will be evaluated by recording End-Tidal Carbon Dioxide (EtCO2).
Post-induction/pre-intubation following 2 minutes of mask ventilation (T3), and immediately post-intubation (T4).
Heart Rate
大体时间:Baseline prior to pre-oxygenation (T1), immediately after pre-oxygenation (T2), post-induction/pre-intubation following 2 minutes of mask ventilation (T3), and immediately post-intubation (T4).
Hemodynamic stability will be evaluated by recording Heart Rate (HR) using standard non-invasive monitor.
Baseline prior to pre-oxygenation (T1), immediately after pre-oxygenation (T2), post-induction/pre-intubation following 2 minutes of mask ventilation (T3), and immediately post-intubation (T4).
Peak Inspiratory Pressure (PIP)
大体时间:Post-induction/pre-intubation following 2 minutes of mask ventilation (T3), and immediately post-intubation (T4).
The efficacy of the mask ventilation techniques will be evaluated by recording Peak Inspiratory Pressure (PIP).
Post-induction/pre-intubation following 2 minutes of mask ventilation (T3), and immediately post-intubation (T4).
Tidal Volume (VT)
大体时间:Post-induction/pre-intubation following 2 minutes of mask ventilation (T3), and immediately post-intubation (T4).
The efficacy of the mask ventilation techniques will be evaluated by recording delivered Tidal Volume (VT).
Post-induction/pre-intubation following 2 minutes of mask ventilation (T3), and immediately post-intubation (T4).

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:EYÜP HORASANLI, Professor、Ankara Bilkent City Hospital Department of Anesthesiology and Reanimation

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月13日

初级完成 (估计的)

2026年10月20日

研究完成 (估计的)

2026年12月5日

研究注册日期

首次提交

2026年5月5日

首先提交符合 QC 标准的

2026年5月8日

首次发布 (实际的)

2026年5月13日

研究记录更新

最后更新发布 (实际的)

2026年5月15日

上次提交的符合 QC 标准的更新

2026年5月13日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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