Optimizing Cerebral Autoregulation During Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Estimated Blood Loss
研究概览
简要总结
The purpose of this study is to conduct a pilot trial to determine the feasibility, safety, and potential efficacy of targeting mean arterial blood pressure (MAP) within the limits of cerebral autoregulation during surgery compared with usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •planned hip or knee surgery (either for fracture or elective) or lung surgery
- •ambulatory at baseline
- •expected duration of surgery > 90 minutes
排除标准
- •Planned concurrent surgery
- •Allergy to adhesive tape
- •Short Blessed Test score >20
- •Clinical diagnosis of dementia
- •Opinion of either the anesthesiologist or surgeon that the patient is not appropriate.
研究组 & 干预措施
Blood pressure managed by cerebral autoregulation
In this arm cerebral autoregulation monitoring will be used to determine the lower and upper limits of cerebral autoregulation. Monitoring will continue throughout the surgery. Blood pressure management will be maintained to be within the limits of cerebral autoregulation.
干预措施: Blood pressure management according to cerebral autoregulation (Other)
Standard of care blood pressure management
In this arm cerebral autoregulation monitoring will be used for observation. The anesthesia provider will use usual care guidelines for blood pressure management.
干预措施: Blood pressure management according to usual care (Other)
结局指标
主要结局
Estimated Blood Loss
时间窗: Intraoperative, up to 5 hours
Blood loss during surgery (mL).
Mean Arterial Pressure Outside Limits of Cerebral Autoregulation
时间窗: Intraoperative, up to 5 hours
Extent (mmHg \* hours) of mean arterial pressure outside limits of cerebral autoregulation after establishment of target mean arterial pressure.
Estimated Blood Loss
时间窗: Intraoperative, up to 5 hours
Blood loss during surgery (mL).
Number of Participants With New Myocardial Infarction After Surgery
时间窗: In the hospital after surgery, up to 2 weeks
Clinically diagnosed new myocardial infarction after surgery as a measure of incidence.
Number of Participants With New Stroke After Surgery
时间窗: In the hospital after surgery, up to 2 weeks
Clinically diagnosed new stroke after surgery as a measure of incidence.
次要结局
- Number of Participants That Develop Delirium After Surgery(In the hospital during the first 3 days after surgery)
- Change in General Function as Assessed by the Instrumental Activities of Daily Living Questionnaire(Approximately 60, 180, and 365 Days after Surgery)
- Change in General Cognitive Function as Assessed by the Short Blessed Test(Approximately 60, 180, and 365 Days after Surgery)
- Dementia Screening as Assessed by the AD8 Test(365 Days after Surgery)
- Change in Ability to Ambulate Without Human Assistance(Approximately 60, 180, and 365 Days after Surgery)
- Change in Executive Cognitive Function as Assessed by the Oral Trail Making Test(Approximately 60, 180, and 365 Days after Surgery)
- Change in General Overall Health and Disability as Assessed by the WHO Disability Assessment Schedule 2.0(Approximately 60, 180, and 365 Days after Surgery)