跳至主要内容
临床试验/NCT01835327
NCT01835327终止不适用

Cerebral Oximetry and Recovery Following Thoracic Surgery

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2012年9月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
130
试验地点
1
主要终点
Post-Operative Quality of Recovery Score (PQRS)

研究概览

简要总结

The current study proposes to address the question of whether patients' cerebral oxygen saturation levels are predictive of their recovery from thoracic surgery. Further, the study poses the hypothesis that a patient's poor recovery status goes on to increase a patient's risk of developing post-operative morbidities such as pneumonia, arrhythmias and delirium. The aim of this study is to address the observation that some patients struggle more than others in their recovery and that 1) this may be a result of intraoperative cerebral oxygen desaturations and 2) that this may affect their post-operative morbidity. If a potential means of predicting poor outcomes is identified this will lead to further research into how to adjust the associated variables, such as cerebral oxygenation, to improve patient post-operative outcome.

详细描述

Despite advances in the field of thoracic surgery, post-operative morbidity continues to be a significant problem with limited understanding of the connection between the insult of surgery and anesthesia and the pathophysiology of the development of these morbidities. Surgeons in the thoracic department have noted that some patients seem to recover less vigorously than other patients. What accounts for these different recovery trajectories is unclear. Researchers have developed a Post-Operative Quality Recovery Scale (PQRS) which assesses six domains (physiologic, nociceptive, emotive, activities of daily living, cognitive, and overall patient experience) and has been suggested to serve as a means of tracking patients' recovery from surgery.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • speak English
  • 18 yo or older
  • willing to participate
  • undergoing thoracic surgery at Mount Sinai Hospital that will require one lung ventilation

排除标准

  • prisoners
  • lack capacity to consent to trial

结局指标

主要结局

Post-Operative Quality of Recovery Score (PQRS)

时间窗: up to 3 months

Patients are assessed 30 minutes, one hour, and three hours post extubation time on day of surgery and then once daily for however long they are hospitalized up to 14 days, patients are then assessed via phone at one month and three months post-op. Recovery is assessed via questions on multiple domains such as pain and nausea, emotional status, activities of daily living and cognitive status.

Post-Operative Morbidity Survey (POMS) Score

时间窗: Post-Operative day 8

The POMS score measures morbidity across multiple categories with pre-defined thresholds, example: Pulmonary (de novo requirement of oxygen supplementation), Infectious (fever above 38C or require antibiotics) etc.

次要结局

  • Cognitive Assessment Method(up to 14 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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