Effects of Manual Versus Autoflow Ventilation During Anesthesia Induction on Cerebral and Peripheral Oxygenation in Geriatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 106
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究者
Fatma GÜLGÜN KILIÇASLAN
Resident
Ankara City Hospital Bilkent
