跳至主要内容
临床试验/NCT04406350
NCT04406350Unknown不适用

Feasibility Study of Isoxic/Normocapnic End-tidal Gas Control to Decrease Incidence of Postoperative Delirium (POD) During Anesthetic Management

University of Manitoba2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2020年6月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
12
试验地点
2
主要终点
Incidence of post-operative delirium

研究概览

简要总结

Respiratory end-tidal gas control is a fundamental of anesthetic management. The range of end-tidal (ET) O2 and CO2 during the conduct of anesthesia is far outside that found in the awake state. Recent work has indicated that alterations in end-tidal gases may influence the incidence of postoperative delirium (POD). This study will examine the feasibility of tight end-tidal gas control during anesthesia to decrease the incidence of POD.

详细描述

A. Background and Rationale:

Although respiratory end-tidal gas control is a fundamental principle of anesthetic management, the range of end-tidal (ET) O2 and CO2 typically seen during the conduct of anesthesia can significantly deviate from the awake baseline state, but has not been considered as a potential contributor to POD in previous investigations. Periods of both hypocapnia during mechanical ventilation and hypercapnia during the reestablishment of spontaneous ventilation are common. The use of 100% oxygen during anesthesia induction and emergence and maintenance of anesthesia with O2 concentrations of 50% are typical. The effects of these alterations in respiratory gases have significant effects on cerebral blood flow and oxygenation, which may be implicated in cognitive dysfunction. The investigators plan to examine the effects of controlled alterations in ET O2 and CO2 during anaesthesia and surgery on the incidence of POD.

B. Hypothesis and Study Objectives:

The investigators advance the hypothesis that ET respiratory gas control is a critical management consideration during anaesthesia; a much more important consideration than previously thought. Older patients appear to be at greater risk of 'intracranial steal' of regional CBF with alterations in CO2 and O2. The investigators previous study confirms an association between CO2 management and POD. Prior MR imaging suggests that a combination of hyperoxia and hypocapnia may be particularly worrisome, a very common situation during anesthesia. The investigators suggest that anesthetic management may be optimized for cerebral health by attempting to maintain respiratory gases at or near the patient baseline values to stabilize CBF during the conduct of anesthesia. An exception occurs during neurosurgical procedures where deliberate alterations to lower ET CO2 may be required. The marked CBF fluctuations as seen with controlled ET gas manipulation in our prior work imply that such CBF changes can occur under anesthesia where similar changes in ET gases routinely occur. The investigators propose that such large alterations in CBF and oxygenation may be a contributing factor to the development of POD in susceptible individuals. Here is proposed a feasibility trial of rigorous maintenance of ET gases at a patient's own baseline to study if such management has an influence on the incidence of POD.

C. Methodology: Summarize study location (facility), eligibility criteria, details regarding recruitment, consent, and randomization, interventions(s), covariates, data sources as applicable.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • able to provide informed consent
  • elective major surgery requiring a minimum stay of 2 days postoperatively
  • no contraindication to MRI

排除标准

  • unable to provide informed consent
  • CO2 retention with Chronic Obstructive Pulmonary Disease (COPD)
  • active congestive heart failure (CHF)
  • unable to participate adequately in delirium screening including those who are blind, deaf, illiterate or not fluent English or French
  • prior episode of intraoperative awareness

结局指标

主要结局

Incidence of post-operative delirium

时间窗: 5 days

Incidence of delirium will be assessed in the Pilot Study Group as measured by the number of positive Confusion Assessment Method (CAM) and CAM-S or CAM for intensive care unit (CAM-ICU) scores, coupled with Chart Review.

次要结局

  • Length of Hospital stay(Time (days) from admission to discharge from hospital (or through study completion at one year))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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