The eFfect of cOntinuous Low Tidal Volume Ventilation With Hyperoxia Avoidance During CardiopUlmonary Bypass "FOCUS" Trial Blood Samples
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 5,502
- 试验地点
- 1
- 主要终点
- Occurrence of Composite including STS 30 day Mortality and postoperative pulmonary complications
研究概览
简要总结
This is a multi-institutional study (CCF, UPMC, OSU) evaluating different ventilation strategies during cardiopulmonary bypass on mortality and postoperative pulmonary complications, with sub-study investigating 8-iso-prostaglandin F2a and sRAGE levels.
详细描述
The investigators will evaluate the effect of low tidal volume with varying FiO2 fractions during cardiopulmonary bypass on postoperative mortality and pulmonary complications. This will be a prospective, pragmatic, cluster randomized trial including all eligible adult cardiac surgical patients requiring cardiopulmonary bypass. Each week, all operating rooms will be randomized to one of three possible ventilation strategies during the period of cardiopulmonary bypass: 1) continuous low tidal volume ventilation with inspired oxygen fraction at 1.0, 2) continuous low tidal volume ventilation with inspired oxygen fraction at 0.21, and 3) no ventilation (apnea). The investigators will anticipate increase in plasma sRAGE and 8-iso-prostaglandin F2a levels in all three groups of patients during CPB with the highest levels immediately after cross-clamp release. The investigators will anticipate significant difference with at least 25% lower sRAGE levels in this group. The sub-study will also provide preliminary data on the behavior of the 8-iso-prostaglandin F2a which will be useful in further investigation of other targeted interventions to reduce ischemia-reperfusion injury to the lung during routine cardiac surgical operations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •>18 years of age
- •Male and female patients undergoing elective cardiac surgeries requiring cardiopulmonary bypass.
排除标准
- •Emergency surgeries, surgeries requiring lung isolation and one-lung ventilation (OLV), heart or lung transplants, and mechanical circulatory support device implantation pulmonary thrombendarterectomies.
- •Surgeries requiring one-lung ventilation will be excluded because of the inability to employ study intervention and the differential treatment of the lungs likely confounding any potential effect from the planned intervention.
- •Lung transplant surgeries will be excluded for similar reasons as well as other confounding effects affecting the primary composite outcome.
- •Heart transplants and mechanical circulatory support device implantation surgeries will be excluded because these patients already receive intervention as part of the institutional protocol at the primary study site.
研究组 & 干预措施
Continuous low-tidal volume ventilation with using FiO2 of 0.21
The investigator will investigate the effect of continuous low tidal volume ventilation with hyperoxia avoidance (using FiO2 of 0.21) on PPCs and 30-day mortality compared to low-tidal volume ventilation (with FiO2 of 0.21) or apnea during CPB, and during the sub-study.
干预措施: Continuous low-tidal volume ventilation with using FiO2 of 0.21 (Other)
Continuous low tidal volume ventilation with using FiO2 of 1.0
The investigator will investigate the effect of low tidal volume lung ventilation with hyperoxia avoidance (FiO2 of 0.21) on PPCs and mortality compared to hyperoxic low-tidal volume ventilation (with FiO2 of 1.0) or apnea during CPB, and during the sub-study.
干预措施: Continuous low tidal volume ventilation with using FiO2 of 1.0 (Other)
Apnea
The investigator will investigate the effect of apnea during on PPCs and mortality compared to hyperoxic low-tidal volume ventilation (with FiO2 of 1.0) or hyperoxia avoidance (FiO2 of 0.21) during CPB, and during the sub-study..
干预措施: Apnea During CPB (Other)
结局指标
主要结局
Occurrence of Composite including STS 30 day Mortality and postoperative pulmonary complications
时间窗: Within 30 days of surgery
Composite including STS 30-day mortality and postoperative pulmonary complications defined a early respiratory failure defined as PaO2/FiO2 ratio\<200 mmHg at any time within the first 24 hours of ICU admission, postoperative reintubation during the hospital stay, prolonged ventilation, pneumonia, pleural effusion requiring drainage, pneumothorax requiring intervention, and readmission due to: pleural effusion requiring intervention, or pneumonia.
次要结局
- ICU LOS(Within 30 days of surgery)
- CPB time(During surgery)
- 30-day mortality(Within 30 days of surgery)
- Hospital LOS(Within 30 days of surgery)
- Need for tracheostomy(Within 30 days of surgery)
- Reintubation(Within 30 days of surgery)
- Early respiratory failure - PaO2/FiO2 ratio < 200 mmHg at any time within the first 24 hours of ICU admission(24 hours)
- Pleural effusion requiring drainage(Within 30 days of surgery)
- Pneumonia(Within 30 days of surgery)
- Readmission(within 30 days of surgery)
研究者
Marta Kelava, MD
PI
The Cleveland Clinic