The Effect of Ventilation on Cerebral Oxygenation in the Sitting Position
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Incidence of Cerebral Desaturation Events
研究概览
简要总结
The aim of this clinical investigation is to determine the effect of intraoperative ventilation on cerebral oxygen saturation in patients undergoing arthroscopic shoulder surgery in the beach chair position (BCP)
详细描述
Recent developments in near-infrared spectroscopy technology now permit rapid assessment of cerebral oxygenation (SctO2) using non-invasive probes. A high incidence cerebral desaturation events (CDE-defined as a decrease in SctO2 values below 20% of baseline measures or absolute SctO2 values ≤ 55 for ≥ 15 seconds) have been observed in previous investigation of patients undergoing shoulder surgery in BCP with hyperventilation. The investigators hypothesize that the incidence of CDE will be reduced in patients ventilated at normocapnic levels (end-tidal carbon dioxide values (ETCO2) of 40-42 mm Hg) when compared to subjects hyperventilated (ETCO2 of 30-32 mm Hg) in the operating room. Patients undergoing shoulder surgery in the BCP will be randomized to a hypocapnic group (ETCO2 of 30-32 mm Hg) or a normocapnic group (ETCO2 of 40-42 mm Hg). Cerebral oxygenation will be measured continuously throughout the procedure to assess perioperative SctO2 values and the incidence of CDE. The investigators previously observed an association between CDE in the operating room and postoperative nausea and vomiting. Therefore, the effect of ventilatory pattern and intraoperative SctO2 on clinical recovery will also be determined.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting for elective shoulder arthroscopy under general anesthesia in the BCP.
排除标准
- •Exclusion criteria include 1) history of pre-existing cerebrovascular disease or orthostatic hypotension 2) age < 18 years 3) American Society of Anesthesiologists Physical Status IV or V.
研究组 & 干预措施
Hypocapnic group
Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
干预措施: Hypocapnic group (Other)
Normocapnic group
Patients will be ventilated to an ETCO2 of 40-42 mm Hg
干预措施: Normocapnic group (Other)
结局指标
主要结局
Incidence of Cerebral Desaturation Events
时间窗: Intraoperative-first 2 hours
Cerebral desaturation events were measured with near-infrared spectroscopy
次要结局
- Number of Patients Experiencing Nausea and Vomiting(Postanesthesia care unit-first 2 hours)
- Postanesthesia Care Unit Length of Stay (Total Time)(Approximately 5 hours)
研究者
Glenn Murphy
Director, Cardiac Anesthesia and Clinical Research
NorthShore University HealthSystem
