HD-Tdcs Associated With The Use Of Dexmedetomidine For Delirium In Critical Patients With Covid-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Delirium Severity
研究概览
简要总结
The goal of this clinical trial Is conducted to evaluate the efficacy and safety of active or sham HD-tDCS in combination with dexmedetomidine in patients with moderate to severe ARDS due to COVID-19 with delirium in intensive care unit (ICU). The hypothesis was that HD-tDCS combined with concomitant dexmedetomidine would reduce delirium rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Applicators were blinded to who was receiving active stimulation and who was receiving placebo. The study drug was prepared by the nurses or nursing technicians, or an otherwise uninvolved research associate so that investigators and clinicians were fully masked to allocation.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥18 years,
- •confirmed clinical diagnosis for SARS-CoV-2,
- •delirium confirmed through the CAM-ICU-7 test, applied by trained evaluators
排除标准
- •severe psychiatric illness that is not well controlled;
- •pregnancy or active lactation,
- •refusal of consent
- •contraindications for brain stimulation such as: aneurysm clips, pacemaker, epilepsy, dermatitis at the site of stimulation
结局指标
主要结局
Delirium Severity
时间窗: 28 days
delirium severity over the 28-day study period is measured using the CAM-ICU-7. Patients discharged before 28 days were considered without delirium.
次要结局
- C-reactive protein levels(28 days)
- ventilator-free days during the first 28 days(28 days)
- Exploratory analisys(28 days)
- length of stay in the ICU and hospital stay(28 days)
- Occurrence of hypotension requiring any vasopressor administration(28 days)
研究者
Suellen Andrade
Principal Investigator
Federal University of Paraíba