Physiology-Guided Airway Preparation Using Standard Oxygen Therapy Improves Hemodynamic Stability and Cerebral Oxygenation During Induction of Anesthesia for Major Spinal Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- MAP variability during induction
研究概览
简要总结
This study looked at a safer way to prepare patients for anesthesia before major spinal surgery. Instead of using advanced or complex oxygen devices, the approach used standard oxygen methods, guided by the patient's individual physiological responses (such as oxygen levels and circulation).
详细描述
We proposed that a physiology-guided airway preparation approach, relying solely on conventional oxygen delivery methods, would enhance haemodynamic stability and cerebral oxygenation during anaesthetic induction in patients undergoing major spinal surgery. The findings are intended to improve patient safety, support better intraoperative decision-making, and potentially encourage wider integration of cerebral oximetry into perioperative neuroprotection strategies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major spinal surgery
- •Under general anesthesia
排除标准
- •Left ventricular ejection fraction < 35%
- •Known intracranial pathology
- •Severe pulmonary disease
- •Body mass index >40 kg•m-²
- •Emergency surgery
- •Planned awake intubation
- •Known autonomic dysfunction
研究组 & 干预措施
Group 3: Physiology-Guided Airway Preparation
Patients will receive face mask preoxygenation as above. A low-flow nasal cannula delivering oxygen at 5 L•min-¹ will be maintained during laryngoscopy. Manual ventilation will be adjusted to achieve an EtCO₂ target of 40-45 mmHg, representing mild permissive hypercapnia.
干预措施: regional cerebral oxygen saturation (Procedure)
Group1: Conventional Airway Preparation
Patients will receive preoxygenation via face mask with oxygen at 6-8 L•min-¹. Spontaneous breathing will be maintained until induction, and manual ventilation will be performed at the discretion of the attending anesthesiologist without predefined EtCO₂ targets.
干预措施: regional cerebral oxygen saturation (Procedure)
Group 2: Structured Conventional Airway Preparation
Patients will receive identical preoxygenation. Following induction, gentle assisted ventilation will be initiated to maintain EtCO₂ between 35 and 40 mmHg, avoiding hyperventilation.
干预措施: regional cerebral oxygen saturation (Procedure)
结局指标
主要结局
MAP variability during induction
时间窗: MAP will be recorded non-invasively at four specific time points: 1 Baseline (before airway preparation) 2 Immediately before intubation 3 Immediately after intubation 4 Five minutes after intubation
Maximum percentage decrease in MAP from baseline between induction and intubation
次要结局
- Incidence of cerebral oxygen desaturation(During endotracheal intubation)
研究者
Mohamed Daabiss
Consultant Anesthesia
Prince Sultan Military Medical City