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临床试验/NCT04084054
NCT04084054招募中不适用

Ultrasonic Measurement of the Optic Nerve Sheath Diameter Predicting Outcome After Cardiac Arrest

Rijnstate Hospital1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2019年12月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
160
试验地点
1
主要终点
Glasgow Coma Scale

研究概览

简要总结

Rationale: An important proportion of patients with return of spontaneous circulation (ROSC) after cardiac arrest remain comatose as a result of post anoxic encephalopathy (PAE). Specific treatments to promote cerebral recovery are lacking. Early identification of patients without potential of recovery of brain functioning may prevent inappropriate continuation of medical treatment and improve communication between doctors and families. Intensivists currently use a combination of diagnostic measures, including brainstem reflexes, motor response, status myoclonus, SSEP measurements and (increasingly) the EEG. However, together all these measure identify only 20-50% of the patients with severe PAE precluding cerebral recovery. At the moment, there is a high demand for bedside measurements that contribute to the neurological prognostication of comatose patients after cardiac arrest. Non-invasive bedside measurements of the optic nerve sheath diameter (ONSD) using ultrasound hold potential to improve outcome prediction.

Objective: To estimate the value and feasibility of repetitive measurements of the ONSD in comatose patients after cardiac arrest.

Study design: Prospective cohort study

Study population: 160 subsequent comatose adult patients after cardiac arrest, admitted to the ICU of Rijnstate hospital

Intervention: In addition to standard treatments, patients will undergo ultrasonic measurements of the ONSD during the first 3 days after cardiac arrest. Survivors will be followed upon hospital discharge. ONSD measurements will be followed over time and related tot neurological outcome.

Main study parameters/endpoints: The primary outcome measure is neurological outcome, defined using the Cerebral Performance Category (CPC) score at 6 months. CPC 1-2 indicates favourable neurological outcome, and CPC 3-5 indicates unfavourable neurological outcome.

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

入选标准

  • Age ≥ 18 years
  • Cardiac arrest
  • Admitted to the ICU with Glasgow Coma Scale ≤ 8

排除标准

  • Pregnancy
  • Traumatic head injury
  • Eye surgery in medical history, including cataract surgery
  • Pre-existing dependency in daily living (CPC 3 or 4)
  • Any known progressive brain illness, such as a brain tumour or neurodegenerative disease

结局指标

主要结局

Glasgow Coma Scale

时间窗: At 6 months after cardiac arrest

Neurological outcome, defined using the Cerebral Performance Category (CPC). CPC 1-2 indicates favourable neurological outcome, and CPC 3-5 indicates unfavourable neurological outcome.

次要结局

未报告次要终点

研究者

发起方
Rijnstate Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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