利用心肺相互作用预测个体化 PEEP 开放肺方法的血流动力学耐受性 (HiPEEP)
使用心肺相互作用参数预测手术室有创机械通气期间采用个体化 PEEP 的开放肺方法的血流动力学耐受性
这是一项观察性、前瞻性、单中心研究,重点关注接受有创机械通气和有创血压监测的大型非心脏手术的患者。 假设:肺复张操作 (RM) 之前的正 TVC(潮气量挑战)预测个体化 PEEP 建立后 5 分钟内 CI 降低至少 10%。
- T0:潮气量挑战开始之前的时刻。 基线值
- T1:潮气量挑战后,立即开始肺复张操作 (RM)。 Mostcare 和呼吸机的价值。
- T2:建立个性化 PEEP 的第 5 分钟。 应监测和记录来自基本监测、Mostcare、Masimo 和呼吸机监测的所有参数。 记录是否已进行任何液体推注。
- T3:建立个性化 PEEP 的第 30 分钟。 血气和 Masimo 值。
研究概览
详细说明
这是一项观察性、前瞻性、单中心研究,重点关注接受有创机械通气和有创血压监测的重大非心脏手术的患者
进行肺复张操作(RM)是为了防止塌陷的肺实质损害氧合。 为了打开塌陷的肺部区域,需要升高胸内压力,这可能会对血流动力学产生影响,特别是对于具有明显或潜在低血容量状态的患者。 每搏输出量变化 (SVV) 或脉压变化 (PPV) 等参数在一定程度上反映了心肺相互作用,并通过利用这一原理检测前负荷依赖性患者,已将其用作液体反应性的预测因子。 潮气量挑战(TVC)采用相同的心肺相互作用原理,效果更好。 TVC 可以预测 RM + 个体化 PEEP 的血流动力学耐受性。
假设:肺复张操作 (RM) 之前的阳性 TVC 预测个体化 PEEP 建立后 5 分钟内 CI 下降至少 10%。
数据将在手术区域收集。 人口统计学和临床参数将从患者的临床病史、从呼吸器获得的呼吸参数、从 Mostcare 和 Masimo 设备获得的血流动力学参数、肺复张操作前后的血气分析获得的氧合参数和参数中收集。
如果患者符合所有纳入标准且不符合任何排除标准,则他/她将被纳入数据收集。 如果他/她受益于招募操作(空中测试+临床适应症),将根据临床适应症进行评估,他/她将进入我们的研究。 所有测量均在稳定的血流动力学条件下进行(HR 和 MAP 应稳定,且测量前 1 分钟内有 +-10% 的变化),当时不使用血管活性药物或有影响的手术攻击。
当进行肺复张操作(RM)时,我们将通过设置以下时间点来监控所有变量:
- T0:招募动作开始前的时刻。 所有描述的变量(Mostcare、血气、呼吸机、Masimo、基本监测)和操作前的液体管理均应受到监测。 为了避免动脉波形出现伪影,应始终执行快速冲洗测试和 dP/dtMAX 评估。 此时不具有最佳动脉波形形态的患者将被排除。
- T1:在启动VTC后的第1分钟,将检查基本监控和Mostcare得出的参数。 从此时起,从 Mostcare 获得的参数将被连续(每分钟)分析,直到建立个性化 PEEP 后 15 分钟。
- T2:建立个性化 PEEP 的第 5 分钟。 应监测和记录来自基本监测、Mostcare、Masimo 和呼吸机监测的所有参数。 记录是否已进行任何液体推注。
- T3:建立个体化PEEP后30分钟内,抽取静脉和动脉血气。 记录是否已进行任何液体推注。
研究类型
注册 (实际的)
联系人和位置
学习地点
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Valencia、西班牙
- Hospital Universitario La Fe
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
纳入标准:
- 18岁以上患者;接受预定的非心胸手术;受控的有创机械通气和有创动脉监测;仰卧位。
排除标准:
- 慢性肺病(定义为3级或以上慢性阻塞性肺病或任何需要长期氧疗的疾病);先天性心脏畸形;严重的瓣膜性心脏病;心力衰竭 NYHA(纽约心脏协会)III/IV 级;心律失常;心室收缩功能降低史(FEVI <40% 或 TAPSE <17 cm/s);有肺动脉高压病史; BMI >35(由于肺顺应性和胸腔改变);心率/呼吸频率比< 3.6;存在吸气用力;打开胸膛;腹内压升高(由于病理或气腹);由于手术(特伦堡位或反特伦堡位)而改变了肺或肋骨顺应性;未校正的最佳动脉波形(共振或阻尼)以及存在肺复张操作的任何禁忌症。 后者是:肺气肿、肺大泡、不受控制的血流动力学不稳定、右心衰竭、颅内压升高(通过颈静脉的回流减少)或缺乏必要的监测、支气管痉挛、未引流的气胸。
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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正潮气量挑战
在潮气量挑战中取得积极结果的人群。
即潮气量从 6 ml/kg 增加到 8 ml/kg 1 分钟后,PPV 增加大于 2%。
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肺泡复张操作是一种经过充分研究的程序,用于在有创机械通气期间打开肺部,使我们能够为该肺实现最佳 PEEP,即个体化 PEEP。
潮气量挑战是一种液体反应测试,包括将潮气量从 6 ml/kg 增加到 8 ml/kg,持续 1 分钟并评估 PPV。
如果PPV增加超过2%,则视为正值,否则为负值。
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负潮气量挑战
在潮气量挑战中结果为阴性的人群。
也就是说,PPV 的增加不够。
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肺泡复张操作是一种经过充分研究的程序,用于在有创机械通气期间打开肺部,使我们能够为该肺实现最佳 PEEP,即个体化 PEEP。
潮气量挑战是一种液体反应测试,包括将潮气量从 6 ml/kg 增加到 8 ml/kg,持续 1 分钟并评估 PPV。
如果PPV增加超过2%,则视为正值,否则为负值。
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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潮汐体积挑战是对开放肺部血流动力学反应的预测指标
大体时间:在招聘操作后的第5分钟
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描述基线潮汐量的挑战与基线差异和5分钟CI(心脏指数)的差异(招募窥视)(开放性肺部方法)之间的关系。
我们认为CI降低10%是临床上的显着意义。
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在招聘操作后的第5分钟
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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心脏肺相互作用以预测对开放肺的血液动力学反应
大体时间:RM后5分钟
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描述基线心肺相互作用之间的关系(脉压变化与潮汐体积挑战的变化,潮汐体积6或8 ml/kg时的脉压变化以及在6或8 ml/kg的潮汐体积时的脉冲变化以及中风体积变化)和基线时心脏指数的差异以及招募操作后1和5分钟的差异(开放性肺部方法)。
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RM后5分钟
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心脏肺相互作用是通过平均动脉压评估的血液动力学耐受性对开放肺部评估的预测指标
大体时间:距招聘机动5分钟
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描述基线心肺相互作用之间的关系(脉压变化与潮汐体积挑战,潮汐体积挑战,潮汐量的脉压变化,潮汐体积的潮气变化,潮汐量的变化和6或8 mL/kg时的潮汐变化和中风体积变化潮汐体积)以及基线时平均动脉压的差异,在招募动作后1到5分钟,采用个性化的窥视率(开放性肺部进近)。
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距招聘机动5分钟
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CI和MAP相关性用于评估开放肺的血液动力学影响
大体时间:距招聘机动5分钟
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评估CI的变化是否与带有个性化PEEP(开放肺接近)RM之前和之后的平均动脉压(MAP)变化相关。
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距招聘机动5分钟
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心肺相互作用是随着时间的流逝的血液动力学耐受性的预测指标
大体时间:距招聘机动15分钟
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描述基线心脏肺相互作用(TVC和脉压变化)与CI(心脏指数)的差异,中风体积变化和基线时的平均动脉压,以及在RM之后的15分钟(带有个性化peep获取)(开放肺癌) 。
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距招聘机动15分钟
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合作者和调查者
调查人员
- 首席研究员:Jose Daniel Jimenez Santana, Resident、University and Polytechnic Hospital La Fe
出版物和有用的链接
一般刊物
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- Writing Committee for the PROBESE Collaborative Group of the PROtective VEntilation Network (PROVEnet) for the Clinical Trial Network of the European Society of Anaesthesiology; Bluth T, Serpa Neto A, Schultz MJ, Pelosi P, Gama de Abreu M; PROBESE Collaborative Group; Bluth T, Bobek I, Canet JC, Cinnella G, de Baerdemaeker L, Gama de Abreu M, Gregoretti C, Hedenstierna G, Hemmes SNT, Hiesmayr M, Hollmann MW, Jaber S, Laffey J, Licker MJ, Markstaller K, Matot I, Mills GH, Mulier JP, Pelosi P, Putensen C, Rossaint R, Schmitt J, Schultz MJ, Senturk M, Serpa Neto A, Severgnini P, Sprung J, Vidal Melo MF, Wrigge H. Effect of Intraoperative High Positive End-Expiratory Pressure (PEEP) With Recruitment Maneuvers vs Low PEEP on Postoperative Pulmonary Complications in Obese Patients: A Randomized Clinical Trial. JAMA. 2019 Jun 18;321(23):2292-2305. doi: 10.1001/jama.2019.7505. Erratum In: JAMA. 2019 Nov 12;322(18):1829-1830. doi: 10.1001/jama.2019.16415.
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