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临床试验/NCT03165539
NCT03165539Unknown不适用

The Effect of Intraoperative Cerebral Oxygen Desaturation on Post-Operative Delirium in Thoracic Surgical Patients: A Pilot Study

University of Manitoba1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Post-operative Delirium vs Cerebral Desaturation

研究概览

简要总结

This study will assess the incidence and risk factors for post-operative delirium in patients undergoing thoracotomy. Specifically, the study will assess if there is any relationship between an intra-operative decrease in brain oxygen levels which can occur during one-lung ventilation, and the occurrence of delirium in the post-operative period.

详细描述

This will be a prospective, observational study on 200 patients. Consenting thoracic surgical patients presenting for open thoracotomy or VATS will be assessed pre-operatively for baseline cognitive status and clinically relevant risk factors for delirium. Intra-operatively, patients will undergo cerebral oxygenation monitoring using near infra-red spectroscopy cerebral oximetry. Postoperatively, patients will be assessed twice daily for the presence or absence of delirium using the Confusion Assessment Methodology (CAM) scoring system during their hospital stay.

A clinically relevant desaturation will be defined as a 25% decrease from the patient's baseline saturation, which will be determined while the patient is breathing room air pre-operatively. The severity and duration of any desaturation will be recorded and subsequently analyzed for correlation with post-operative delirium. Bivariate associations between the risk of delirium and predictor variables will be sought. If appropriate, logistic regression models will be constructed with the outcome of delirium.

Significance: Previous studies at our centre have resulted in over 35% of thoracic surgical patients developing significant, intra-operative cerebral desaturation. We propose to study a convenience sample of 200 consecutive patients. Depending on the relative risk of developing delirium with a significant cerebral desaturation, this study may be adequately powered to determine the associated risk of delirium. This study will provide background information in planning further interventional trials to prevent desaturation and possibly reduce the incidence of delirium, as well as aid in the planning of larger multi-center trials to more accurately assess the risk of intra-operative decreases in cerebral oxygenation and the role this event contributes to the occurrence of delirium.

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
50 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing a thoracic surgical procedure with one-lung ventilation.

排除标准

  • Inability to communicate in English
  • Lack of informed consent

结局指标

主要结局

Post-operative Delirium vs Cerebral Desaturation

时间窗: 5 days

Incidence of delirium will be assessed post-operatively up to POD 5 as measured by positive Confusion Assessment Method (CAM) scores and correlated with clinically relevant cerebral desaturation (greater than a 25% decrease from baseline)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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