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临床试验/NCT01546636
NCT01546636已完成不适用

The Effect of Ventilation on Cerebral Oxygenation in the Sitting Position

NorthShore University HealthSystem2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2010年11月最近更新:
适应症
干预措施

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

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

Placebo Comparator

Patients will be ventilated to an ETCO2 of 30-32 mm Hg.

干预措施: Hypocapnic group (Other)

Normocapnic group

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Glenn Murphy

Director, Cardiac Anesthesia and Clinical Research

NorthShore University HealthSystem

研究点 (2)

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