NCT06590311尚未招募不适用
Autonomic Modulation in Patients Undergoing Assisted Mechanical Ventilation: Comparison Between PAV+ and PSV
University of Roma La Sapienza1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年9月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- LF dominion
研究概览
简要总结
The aim of the study is to investigate autonomic modulation in terms of heart rate variability (i.e., HRV) in patients undergoing assisted mechanical ventilation in PSV mode, compared to patients assisted in PAV+ mode. The hypothesis is that the greater patient-ventilator synchrony of the latter mode may represent an advantage in reducing the imbalance of autonomic modulation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 否
入选标准
- •Patients admitted to the ICU, ≥18 years old, undergoing invasive controlled mechanical ventilation for at least 72 hours, eligible for assisted support but not yet ready for extubation or spontaneous breathing.
排除标准
- •Successful completion of a spontaneous breathing trial (SBT) and spontaneous breathing within 24 hours of enrollment
- •Acute ischemic heart disease, cardiac rhythm abnormalities, and/or patients with pacemakers and/or treated with anti-arrhythmic drugs
- •Hemodynamic instability
- •Chest drainage
- •Severe anemia (Hb <7g/dL)
- •Pregnancy
- •Severe head trauma, dementia
- •High spinal cord injury
- •Neuromuscular disorders
- •Lack of consent
结局指标
主要结局
LF dominion
时间窗: 30 min
To evaluate the difference in the LF domain between patients assisted in PSV and those assisted in PAV+ at T1 (30 minutes).
次要结局
- Other domains(30 min to 72 hours)
- Clinical outcomes(28 days)
研究者
Francesco Alessandri
Professor
University of Roma La Sapienza
研究点 (1)
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