跳至主要内容
临床试验/NCT07267416
NCT07267416招募中不适用

Prospective Randomized Controlled Study on the Impact of Combined PSi + NIRS Monitoring in the Prevention of Postoperative Cognitive Disorders in Cardiac Surgery.

Brugmann University Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年5月13日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
MoCA (Montreal Cognitive Assessment)

研究概览

简要总结

Advances in cardiac medicine and anesthesia have made it possible to expand the indications for open heart surgery to increasingly older and more complex patients. This development is taking place in a demographic context where the aging of the world population has become a structural reality. However, postoperative neurocognitive complications, and in particular postoperative cognitive disorders (POCD), are not limited to the elderly. They can affect all adults, including younger adults, particularly in the presence of risk factors such as prolonged cardiopulmonary bypass, deep anesthesia, or episodes of intraoperative cerebral desaturation.

The PSi-NIRS study was designed with this broad perspective in mind. It will include all adult patients (≥18 years) eligible for cardiac surgery under extracorporeal circulation, with a secondary analysis dedicated to patients aged 65 years and older, a group in which POCD is more frequent, more long-lasting, and often has more serious consequences. This division will allow to assess the impact of cerebral monitoring both in the general adult population and within a well-defined geriatric subgroup.

The pathophysiological mechanisms involved in POCD are now better understood. On the one hand, insufficient cerebral oxygenation, even transient, can disrupt neuronal homeostasis for a prolonged period. On the other hand, excessively deep anesthesia, leading to periods of EEG suppression, is recognized as a risk marker for delirium and postoperative cognitive decline. These two dimensions - perfusion and cortical activity - constitute complementary targets for prevention.

Independently of each other, two tools available today - near-infrared spectroscopy (NIRS) and processed electroencephalography (PSi via SedLine®) - have shown their value in cardiac surgery. The use of NIRS to guide intraoperative adjustments has been associated with a reduction in neurological complications. Anesthetic guidance by EEG makes it possible to limit periods of suppression, linked to an increased risk of delirium and POCD. However, to date, no randomized study has evaluated the combined and coordinated use of these two modalities, with a predefined therapeutic algorithm allowing real-time clinical intervention based on critical thresholds.

The PSi-NIRS study is therefore part of a logic of scientific continuity, but takes a methodological step forward by testing for the first time an integrated and proactive approach to cerebral monitoring, applied to a surgical context with high neurological risk. It aims to verify whether this strategy can improve the postoperative cognitive trajectory of patients, in the short and medium term, by targeting the real points of intraoperative cerebral vulnerability.

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
None

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

  • Elective or relatively emergency surgery for valve surgery (pulmonary or tricuspid valves) or coronary artery bypass grafting (CABG)
  • Preoperative cognitive assessment MoCA ≥ 20 (during the preoperative consultation if applicable or on day 1)
  • ASA score II to IV

排除标准

  • History of sequelae of stroke
  • Diagnosis or strong suspicion of dementia (according to DSM-V criteria).
  • Preoperative encephalopathy
  • Severe chronic renal failure requiring dialysis
  • Patients with chronic respiratory failure who are oxygen-dependent

结局指标

主要结局

MoCA (Montreal Cognitive Assessment)

时间窗: Baseline, pre-surgery

Rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.The total possible score is 30 points; a score of 26 or above is considered normal.

MoCA (Montreal Cognitive Assessment)

时间窗: 2 days post surgery

Rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.The total possible score is 30 points; a score of 26 or above is considered normal.

MoCA (Montreal Cognitive Assessment)

时间窗: 7 days post surgery

Rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.The total possible score is 30 points; a score of 26 or above is considered normal.

MoCA (Montreal Cognitive Assessment)

时间窗: 25 days post surgery

Rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.The total possible score is 30 points; a score of 26 or above is considered normal.

MoCA (Montreal Cognitive Assessment)

时间窗: 30 days post surgery

Rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.The total possible score is 30 points; a score of 26 or above is considered normal.

次要结局

  • Postoperative length of stay(Immediately after the surgery)
  • Cumulative duration of burst deletions (SedLine)(During the surgery)
  • Cumulative duration of NIRS desaturation episodes(During the surgery)

研究者

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

Tatiana Besse-Hammer

Head of Clinical Research Unit

Brugmann University Hospital

研究点 (1)

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