NCT07294768已完成不适用
Mechanical Power-Guided Lung Protective Ventilation (VentCoach) in Acute Hypoxemic and/or Hypercapnic Respiratory Failure: A Feasibility, Double Arm, Single-blinded Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Adherence to the VentCoach protocol
研究概览
简要总结
The purpose of this research is to evaluate a different way of using the mechanical ventilator device to help better protect the lungs while the patient recovers. We will compare VentCoach to the current standard mechanical ventilation techniques used in our Intensive Care Units.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
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 with acute hypoxemic and/or hypercapnic respiratory failure.
- •Patients requiring intubation and mechanical ventilation for more than 24 hours.
- •VentCoach protocol is specific to volume controlled continuous mandatory ventilation (S-CMV).
- •Patient who are admitted to RMH 10-3/10-4 and MB 6BGF ICUs.
- •Age greater than or equal to 18 years.
- •Patient's legal representative should be able to provide informed consent to the study. Any participant speaking any language will be offered participation.
排除标准
- •Intubation and mechanical ventilation for airway protection in the setting of procedures/surgeries, e.g. interventional radiology, surgery, or endoscopy.
- •Intubation and mechanical ventilation due to drug overdose with expected extubation of less than 24 hours.
- •Intubation and mechanical ventilation in the setting of cardiac arrest.
- •Intubation and mechanical ventilation for a primary neurological etiology, e.g. increased intracranial pressure, tumor mass effect, ischemic/hemorrhagic stroke, status epilepticus, etc.
- •Mechanical ventilation to be guided by esophageal balloon.
- •Subject deprived of freedom, minor, subject under a legal protective measure.
- •Change in end-of-life decision anticipated after enrollment (or estimated 6-month mortality rate of greater than 50%).
- •Note: prone positioning is not a contraindication for participation.
结局指标
主要结局
Adherence to the VentCoach protocol
时间窗: 1 year
Total number of patients to achieve adherence will be defined as documented reduction in mechanical power (MP) or MP less than 12 J/min, in the 16 patients assigned to the VentCoach group
次要结局
- Overall use of sedation(1 year)
- Time to removal from ventilator(1 year)
- Incidence of patient-ventilator dyssynchrony(1 year)
- Overall use of paralytics(1 year)
- Oxygenation index(Baseline, end of treatment (up to 14 days))
研究者
Gustavo A. Cortes Puentes
Principal Investigator
Mayo Clinic
研究点 (1)
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