positive end-expiratory pressure

呼气末正压
  • 文章类型: Case Reports
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  • 文章类型: Journal Article
    背景:先前的研究报道了关于驱动压力引导通气与术后肺部并发症(PPC)之间的相关性的不一致结果。我们旨在调查驱动压力引导通气是否与PPC的低风险相关。
    方法:我们系统地在电子数据库中搜索RCTs,比较成年手术患者的驱动压力引导通气和常规保护性通气。主要结果是PPC的复合物。次要结果是肺炎,肺不张,和急性呼吸窘迫综合征(ARDS)。采用Meta分析和亚组分析计算95%置信区间(CI)的风险比(RR)。试验序贯分析(TSA)用于评估证据的结论性。
    结果:纳入了13个RCTs,3401名受试者。驱动压力引导通气与PPC风险较低相关(RR0.70,95%CI0.56-0.87,P=0.001),如TSA所示。亚组分析(相互作用的P=0.04)发现,在非心胸外科手术中观察到了这种关联(9个随机对照试验,1038个科目,RR0.61,95%CI0.48-0.77,P<0.0001),运输安全管理局提出了充分的证据和确凿的结果;然而,它在心胸外科手术中没有达到意义(四个随机对照试验,2363个科目,RR0.86,95%CI0.67-1.10,P=0.23),TSA表明证据不足,结果不确定。同样,非心胸手术的肺炎风险较低,但心胸手术的肺炎风险较低(P=0.046).两种通气策略在肺不张和ARDS方面没有发现显着差异。
    结论:在非心胸外科手术中,驱动压力引导通气与术后肺部并发症的风险较低相关,而在心胸外科手术中没有。
    插入202410068。
    BACKGROUND: Prior studies have reported inconsistent results regarding the association between driving pressure-guided ventilation and postoperative pulmonary complications (PPCs). We aimed to investigate whether driving pressure-guided ventilation is associated with a lower risk of PPCs.
    METHODS: We systematically searched electronic databases for RCTs comparing driving pressure-guided ventilation with conventional protective ventilation in adult surgical patients. The primary outcome was a composite of PPCs. Secondary outcomes were pneumonia, atelectasis, and acute respiratory distress syndrome (ARDS). Meta-analysis and subgroup analysis were conducted to calculate risk ratios (RRs) with 95% confidence intervals (CI). Trial sequential analysis (TSA) was used to assess the conclusiveness of evidence.
    RESULTS: Thirteen RCTs with 3401 subjects were included. Driving pressure-guided ventilation was associated with a lower risk of PPCs (RR 0.70, 95% CI 0.56-0.87, P=0.001), as indicated by TSA. Subgroup analysis (P for interaction=0.04) found that the association was observed in non-cardiothoracic surgery (nine RCTs, 1038 subjects, RR 0.61, 95% CI 0.48-0.77, P< 0.0001), with TSA suggesting sufficient evidence and conclusive result; however, it did not reach significance in cardiothoracic surgery (four RCTs, 2363 subjects, RR 0.86, 95% CI 0.67-1.10, P=0.23), with TSA indicating insufficient evidence and inconclusive result. Similarly, a lower risk of pneumonia was found in non-cardiothoracic surgery but not in cardiothoracic surgery (P for interaction=0.046). No significant differences were found in atelectasis and ARDS between the two ventilation strategies.
    CONCLUSIONS: Driving pressure-guided ventilation was associated with a lower risk of postoperative pulmonary complications in non-cardiothoracic surgery but not in cardiothoracic surgery.
    UNASSIGNED: INPLASY 202410068.
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  • 文章类型: Journal Article
    背景:术后肺部并发症(PPCs)与术后死亡率和住院时间延长有关。尽管术中机械通气(MV)是PPC的危险因素,解决从MV断奶的策略研究不足。在这次系统审查中,我们评估了撤机策略及其对术后肺部结局的影响.
    方法:我们的方案在PROSPERO(CRD42022379145)上注册。符合条件的研究包括随机对照试验和对手术室中脱离MV的成年人的观察性研究。主要结果包括肺不张和氧合;次要结果包括肺容积变化和PPC。使用Cochrane偏差风险(RoB2)工具评估偏差风险,以及使用等级框架的证据质量。
    结果:筛查确定了14项随机对照试验,包括1719例患者;7项研究仅限于断奶期,7项研究包括不限于断奶期的干预措施。将压力支持通气(PSV)与呼气末正压(PEEP)和低吸入氧气(FiO2)相结合的策略可改善肺不张,氧合,和肺容量。低FiO2改善了肺不张和氧合,但可能无法改善肺容量。固定PEEP策略没有改善氧合或肺不张;然而,低FiO2的个性化PEEP可改善氧合,并可能与PPC减少有关。一半的纳入研究存在中度或高度偏倚风险;总体证据质量较低。
    结论:评估术中MV断奶的研究有限。基于低质量的证据,PSV,个性化PEEP,低FiO2可能与术后肺部结局降低有关。
    PROSPERO(CRD42022379145)。
    BACKGROUND: Postoperative pulmonary complications (PPCs) are associated with postoperative mortality and prolonged hospital stay. Although intraoperative mechanical ventilation (MV) is a risk factor for PPCs, strategies addressing weaning from MV are understudied. In this systematic review, we evaluated weaning strategies and their effects on postoperative pulmonary outcomes.
    METHODS: Our protocol was registered on PROSPERO (CRD42022379145). Eligible studies included randomised controlled trials and observational studies of adults weaned from MV in the operating room. Primary outcomes included atelectasis and oxygenation; secondary outcomes included lung volume changes and PPCs. Risk of bias was assessed using the Cochrane Risk of Bias (RoB2) tool, and quality of evidence with the GRADE framework.
    RESULTS: Screening identified 14 randomised controlled trials including 1719 patients; seven studies were limited to the weaning phase and seven included interventions not restricted to the weaning phase. Strategies combining pressure support ventilation (PSV) with positive end-expiratory pressure (PEEP) and low fraction of inspired oxygen (FiO2) improved atelectasis, oxygenation, and lung volumes. Low FiO2 improved atelectasis and oxygenation but might not improve lung volumes. A fixed-PEEP strategy led to no improvement in oxygenation or atelectasis; however, individualised PEEP with low FiO2 improved oxygenation and might be associated with reduced PPCs. Half of included studies are of moderate or high risk of bias; the overall quality of evidence is low.
    CONCLUSIONS: There is limited research evaluating weaning from intraoperative MV. Based on low-quality evidence, PSV, individualised PEEP, and low FiO2 may be associated with reduced postoperative pulmonary outcomes.
    UNASSIGNED: PROSPERO (CRD42022379145).
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  • 文章类型: Journal Article
    目的:分析呼气末正压(PEEP)变化对急性脑损伤(ABI)患者颅内压(ICP)动力学的影响。
    方法:观察性,前瞻性和多中心研究(PEEP-PIC研究)。
    方法:西班牙17个重症监护病房。
    方法:2017年11月至2018年6月接受侵入性神经监测的神经危重患者。
    方法:基线通气,在PEEP改变之前和之后的30分钟内收集血液动力学和神经监测变量。
    方法:PEEP和ICP变化。
    结果:纳入了109名患者。平均年龄为52.68(15.34)岁,男性71人(65.13%)。在54例(49.54%)患者中,创伤性脑损伤是ABI的原因。机械通气时间为16.52(9.23)天。住院死亡率为21.1%。PEEP增加(平均6.24-9.10cmH2O)导致ICP从10.4增加到11.39mmHg,P<.001,脑灌注压(CPP)无变化(P=.548)。PEEP降低(平均8.96至6.53cmH2O)导致ICP从10.5mmHg降低至9.62mmHg(P=0.052),CPP无变化(P=.762)。ICP的增加与ΔPEEP之间建立了显着的相关性(R=0.28,P<.001),delta驱动压力(R=0.15,P=.038)和delta顺应性(R=-0.14,P=.052)。基线ICP较低的患者的ICP增量较高。
    结论:PEEP改变与ABI患者ICP值的临床相关改变无关。PEEP增加后ICP的变化幅度与PEEP的增量相关,三角洲驱动压力和三角洲顺应性。
    OBJECTIVE: To analyze the impact of positive end-expiratory pressure (PEEP) changes on intracranial pressure (ICP) dynamics in patients with acute brain injury (ABI).
    METHODS: Observational, prospective and multicenter study (PEEP-PIC study).
    METHODS: Seventeen intensive care units in Spain.
    METHODS: Neurocritically ill patients who underwent invasive neuromonitorization from November 2017 to June 2018.
    METHODS: Baseline ventilatory, hemodynamic and neuromonitoring variables were collected immediately before PEEP changes and during the following 30 min.
    METHODS: PEEP and ICP changes.
    RESULTS: One-hundred and nine patients were included. Mean age was 52.68 (15.34) years, male 71 (65.13%). Traumatic brain injury was the cause of ABI in 54 (49.54%) patients. Length of mechanical ventilation was 16.52 (9.23) days. In-hospital mortality was 21.1%. PEEP increases (mean 6.24-9.10 cmH2O) resulted in ICP increase from 10.4 to 11.39 mmHg, P < .001, without changes in cerebral perfusion pressure (CPP) (P = .548). PEEP decreases (mean 8.96 to 6.53 cmH2O) resulted in ICP decrease from 10.5 to 9.62 mmHg (P = .052), without changes in CPP (P = .762). Significant correlations were established between the increase of ICP and the delta PEEP (R = 0.28, P < .001), delta driving pressure (R = 0.15, P = .038) and delta compliance (R = -0.14, P = .052). ICP increment was higher in patients with lower baseline ICP.
    CONCLUSIONS: PEEP changes were not associated with clinically relevant modifications in ICP values in ABI patients. The magnitude of the change in ICP after PEEP increase was correlated with the delta of PEEP, the delta driving pressure and the delta compliance.
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  • 文章类型: Journal Article
    目的:越来越多的证据表明危重患者的肺和肾之间存在复杂的相互作用。肾阻力指数(RRI)是对肾血流阻力的床边测量,与肾损伤相关。呼气末正压(PEEP)水平可影响肾血流阻力,因此,我们假设RRI有助于监测不同PEEP水平下肾脏血流动力学的变化.我们的假设是,ICU入院时的RRI可以预测机械通气危重患者发生急性肾损伤的风险。
    方法:我们进行了一项前瞻性研究,包括92例需要机械通气时间≥48h的患者。RRI≥0.70被认为是病理性的。在ICU入院后24小时内测量RRI,同时以随机顺序应用5、10和15cmH2O的PEEP(PEEP试验)。
    结果:总体而言,RRI从PEEP5的0.62±0.09增加到PEEP15的0.66±0.09(p<0.001)。PEEP试验期间的平均RRI值能够预测AKI的发生,AUROC=0.834[95CI0.742-0.927]。表现出RRI≥0.70的患者在PEEP5时为17/92(18%),在PEEP10时为28/92(30%),在PEEP15时为38/92(41%)。在PEEP试验期间,38例患者(41%)至少一次表现出RRI≥0.70。在这些患者中,55%的病例发生AKI,与13%的剩余患者相比,p<0.001。
    结论:RRI似乎能够预测机械通气患者发生AKI的风险;RRI值受所应用的PEEP水平的影响。
    背景:临床政府NCT03969914于2019年5月31日注册。
    OBJECTIVE: Growing evidence shows the complex interaction between lung and kidney in critically ill patients. The renal resistive index (RRI) is a bedside measurement of the resistance of the renal blood flow and it is correlated with kidney injury. The positive end-expiratory pressure (PEEP) level could affect the resistance of renal blood flow, so we assumed that RRI could help to monitoring the changes in renal hemodynamics at different PEEP levels. Our hypothesis was that the RRI at ICU admission could predict the risk of acute kidney injury in mechanical ventilated critically ill patients.
    METHODS: We performed a prospective study including 92 patients requiring mechanical ventilation for ≥ 48 h. A RRI ≥ 0.70, was deemed as pathological. RRI was measured within 24 h from ICU admission while applying 5,10 and 15 cmH2O of PEEP in random order (PEEP trial).
    RESULTS: Overall, RRI increased from 0.62 ± 0.09 at PEEP 5 to 0.66 ± 0.09 at PEEP 15 (p < 0.001). The mean RRI value during the PEEP trial was able to predict the occurrence of AKI with AUROC = 0.834 [95%CI 0.742-0.927]. Patients exhibiting a RRI ≥ 0.70 were 17/92(18%) at PEEP 5, 28/92(30%) at PEEP 10, 38/92(41%) at PEEP 15, respectively. Thirty-eight patients (41%) exhibited RRI ≥ 0.70 at least once during the PEEP trial. In these patients, AKI occurred in 55% of the cases, versus 13% remaining patients, p < 0.001.
    CONCLUSIONS: RRI seems able to predict the risk of AKI in mechanical ventilated patients; further, RRI values are influenced by the PEEP level applied.
    BACKGROUND: Clinical gov NCT03969914 Registered 31 May 2019.
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  • 文章类型: Journal Article
    急性脑损伤(ABI)患者是一个特殊的人群,因为ABI不仅会影响大脑,还会影响其他器官,例如肺,如脑肺串扰模型中的理论。ABI患者通常需要机械通气(MV),以避免ABI后呼吸功能受损的并发症;由于MV对颅内室的影响,应谨慎处理。尤其是关于呼气末正压(PEEP)。本范围综述旨在(1)描述与PEEP在ABI中的作用相关的生理基础和机制;(2)研究如何在该主题上进行临床研究;(3)确定在ABI中设置PEEP的方法;(4)研究在ABI中应用PEEP对结果的影响。
    Peters等人设计的五阶段范式。并由Arksey和O\'Malley扩展,Levac等人。,乔安娜·布里格斯研究所被用于方法论。我们还遵守了系统审查和荟萃分析(PRISMA)扩展标准的首选报告项目。纳入标准:我们收集了来自同行评审期刊和研究的所有科学数据,这些研究讨论了PEEP的应用及其对颅内压的影响,脑灌注压,成人ABI患者的脑氧合。排除标准:仅检查儿科患者组(18岁以下)的研究,仅在动物上进行的实验;没有颅内压和/或脑灌注压测定的研究,和不完整信息的研究。两位作者使用PubMed索引的在线数据库搜索并筛选了截至2023年7月发表的论文。数据以叙述和管状形式呈现。
    最初的搜索产生了330个关于PEEP在ABI中应用的参考文献,其中36人符合我们的纳入标准。PEEP对气体交换有公认的有益效果,但它产生的血流动力学变化,应该预测,以避免对脑血流量和颅内压的不良后果。此外,肺部的弹性特性影响MV在大脑上施加的力的传递,因此应将其考虑在内。目前,没有特定的工具可以预测PEEP对大脑的影响,但是对于这些患者,需要一种全面的监测方法,承认ABI的病因和可测量的变量来个性化MV。
    PEEP可以安全地用于ABI患者,以改善气体交换,同时牢记其潜在的有害影响,这可以通过床边非侵入性神经监测工具支持的充分监测来预测。
    UNASSIGNED: Patients with acute brain injury (ABI) are a peculiar population because ABI does not only affect the brain but also other organs such as the lungs, as theorized in brain-lung crosstalk models. ABI patients often require mechanical ventilation (MV) to avoid the complications of impaired respiratory function that can follow ABI; MV should be settled with meticulousness owing to its effects on the intracranial compartment, especially regarding positive end-expiratory pressure (PEEP). This scoping review aimed to (1) describe the physiological basis and mechanisms related to the effects of PEEP in ABI; (2) examine how clinical research is conducted on this topic; (3) identify methods for setting PEEP in ABI; and (4) investigate the impact of the application of PEEP in ABI on the outcome.
    UNASSIGNED: The five-stage paradigm devised by Peters et al. and expanded by Arksey and O\'Malley, Levac et al., and the Joanna Briggs Institute was used for methodology. We also adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) extension criteria. Inclusion criteria: we compiled all scientific data from peer-reviewed journals and studies that discussed the application of PEEP and its impact on intracranial pressure, cerebral perfusion pressure, and brain oxygenation in adult patients with ABI. Exclusion criteria: studies that only examined a pediatric patient group (those under the age of 18), experiments conducted solely on animals; studies without intracranial pressure and/or cerebral perfusion pressure determinations, and studies with incomplete information. Two authors searched and screened for inclusion in papers published up to July 2023 using the PubMed-indexed online database. Data were presented in narrative and tubular form.
    UNASSIGNED: The initial search yielded 330 references on the application of PEEP in ABI, of which 36 met our inclusion criteria. PEEP has recognized beneficial effects on gas exchange, but it produces hemodynamic changes that should be predicted to avoid undesired consequences on cerebral blood flow and intracranial pressure. Moreover, the elastic properties of the lungs influence the transmission of the forces applied by MV over the brain so they should be taken into consideration. Currently, there are no specific tools that can predict the effect of PEEP on the brain, but there is an established need for a comprehensive monitoring approach for these patients, acknowledging the etiology of ABI and the measurable variables to personalize MV.
    UNASSIGNED: PEEP can be safely used in patients with ABI to improve gas exchange keeping in mind its potentially harmful effects, which can be predicted with adequate monitoring supported by bedside non-invasive neuromonitoring tools.
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  • 文章类型: Journal Article
    背景:在需要全身麻醉的患者中,肺保护性通气可以预防术后肺部并发症,这与更高的发病率有关,死亡率,并延长住院时间。呼气末正压(PEEP)的应用是肺保护性通气的一个组成部分。设定适当PEEP的正确策略,然而,仍然有争议。PEEP设置导致吸气末平台压力和呼气末压力之间的压力差降低(“驱动压力,\“ΔP)可以降低术后肺部并发症的风险。初步数据表明,PEEP需要防止吸气末扩张和呼气末肺泡塌陷,从而降低ΔP,与患者的体重指数(BMI)呈正相关,PEEP值对应于患者各自BMI的约1/3。因此,我们假设根据患者BMI调整PEEP可降低ΔP,并可减少术后肺部并发症.
    方法:将接受全身麻醉和气管插管的患者进行容量控制通气,潮气量为7ml/kg预测体重,并随机分配给根据BMI调整PEEP的干预组或标准PEEP为5mbar的对照组。术前和术后,将进行肺超声检查以确定肺通气评分,血液动力学和呼吸生命体征将被记录用于后续评估。主要结果是ΔP作为肺保护性通气的替代参数的差异。次要结果包括肺通气评分的变化,术中血流动力学和呼吸事件的发生,氧需求和术后肺部并发症。
    结论:研究结果将表明,基于BMI调整PEEP的术中通气策略是否具有降低术后肺部并发症风险的潜力,作为一种易于实施的干预措施,不需要长时间的呼吸机操作,也不需要额外的设备。
    背景:德国临床试验注册(DRKS),DRKS00031336。2023年2月21日注册。
    方法:研究方案得到了基尔基督教-阿尔布雷希茨大学伦理委员会的批准,德国,2023年2月1日招聘始于2023年3月,预计将于2023年9月结束。
    BACKGROUND: In patients requiring general anesthesia, lung-protective ventilation can prevent postoperative pulmonary complications, which are associated with higher morbidity, mortality, and prolonged hospital stay. Application of positive end-expiratory pressure (PEEP) is one component of lung-protective ventilation. The correct strategy for setting adequate PEEP, however, remains controversial. PEEP settings that lead to a lower pressure difference between end-inspiratory plateau pressure and end-expiratory pressure (\"driving pressure,\" ΔP) may reduce the risk of postoperative pulmonary complications. Preliminary data suggests that the PEEP required to prevent both end-inspiratory overdistension and end-expiratory alveolar collapse, thereby reducing ΔP, correlates positively with the body mass index (BMI) of patients, with PEEP values corresponding to approximately 1/3 of patient\'s respective BMI. Thus, we hypothesize that adjusting PEEP according to patient BMI reduces ΔP and may result in less postoperative pulmonary complications.
    METHODS: Patients undergoing general anesthesia and endotracheal intubation with volume-controlled ventilation with a tidal volume of 7 ml per kg predicted body weight will be randomized and assigned to either an intervention group with PEEP adjusted according to BMI or a control group with a standardized PEEP of 5 mbar. Pre- and postoperatively, lung ultrasound will be performed to determine the lung aeration score, and hemodynamic and respiratory vital signs will be recorded for subsequent evaluation. The primary outcome is the difference in ΔP as a surrogate parameter for lung-protective ventilation. Secondary outcomes include change in lung aeration score, intraoperative occurrence of hemodynamic and respiratory events, oxygen requirements and postoperative pulmonary complications.
    CONCLUSIONS: The study results will show whether an intraoperative ventilation strategy with PEEP adjustment based on BMI has the potential of reducing the risk for postoperative pulmonary complications as an easy-to-implement intervention that does not require lengthy ventilator maneuvers nor additional equipment.
    BACKGROUND: German Clinical Trials Register (DRKS), DRKS00031336. Registered 21st February 2023.
    METHODS: The study protocol was approved by the ethics committee of the Christian-Albrechts-Universität Kiel, Germany, on 1st February 2023. Recruitment began in March 2023 and is expected to end in September 2023.
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  • 文章类型: Journal Article
    在这项研究中,我们研究了不同氧疗方案对急性A型主动脉夹层(AAD)患者氧合的影响.
    进行了一项准随机对照试验,其中2021年6月至9月住院手术的AAD患者被分配到对照组(患者在术后机械通气后接受常规氧疗,断奶,和拔管)以及2021年10月至12月入院的患者被分配到观察组[患者在对照组治疗的基础上接受了最佳调整治疗,主要包括优先提高呼气末正压(PEEP)和限制使用吸入氧气分数(FiO2)]。术后氧合指数,血气分析,比较两组机械通气时间。
    两组在术后2小时观察到的氧合存在显著差异。术后12、24和72小时,两组的氧合指数差异显著.两组氧合指数和PaO2的时间效应差异有统计学意义。以及在重症监护病房住院时间的显着差异。
    对于AAD患者的术后护理,建议维持患者氧合所需的最低FiO2。此外,当PaO2较低时,可以优先提高PEEP。
    UNASSIGNED: In this study, we investigated the effect of various oxygen therapy regimens on oxygenation in patients with acute type A aortic dissection (AAD).
    UNASSIGNED: A quasi-randomized controlled trial was conducted, in which patients with AAD hospitalized for surgery from June to September 2021 were assigned to the control group (patients received conventional oxygen therapy after postoperative mechanical ventilation, weaning, and extubation) and those who were admitted from October to December 2021 were assigned to the observation group [patients underwent optimally adjusted therapy based on the treatment of the control group, which mainly included prioritized elevation of positive end-expiratory pressure (PEEP) and restricted use of the fraction of inspired oxygen (FiO2)].The postoperative oxygenation index, blood gas analysis, and duration of mechanical ventilation were compared between the two groups.
    UNASSIGNED: There were significant differences in oxygenation observed at 2 h postoperatively between the groups. 12, 24, and 72 h postoperatively, the oxygenation index varied significantly between the two groups. There were statistically significant differences in the time effects of the oxygenation index and PaO2 between the two groups, as well as significant differences in the length of stay in the intensive care unit.
    UNASSIGNED: For the postoperative care of patients with AAD, it is suggested that the minimum FiO2 required for oxygenation of patients be maintained. In addition, it is possible to enhance PEEP as a priority when PaO2 is low.
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  • 文章类型: Journal Article
    驱动压力(ΔP)是机械通气(MV)的核心治疗成分。在MV期间,根据潜在病理类型和损伤的严重程度,使用了不同水平的ΔP。然而,ΔP水平也被证明对死亡率等硬终点有密切的影响。考虑到这一点,进行了深入的审查作为一个独特的ΔP,影响预后的治疗方式极为重要.有必要了解确保ΔP水平得到优化以增强结果并最大程度地减少伤害所涉及的微妙之处。我们进行了这篇叙述性综述,以进一步探讨ΔP的各种用途,可能影响其使用的不同参数,以及不同患者人群在不同压力水平下的结果如何变化。为了在需要MV的患者中更好地利用ΔP,还需要更多的大规模临床研究.
    Driving pressure (∆P) is a core therapeutic component of mechanical ventilation (MV). Varying levels of ∆P have been employed during MV depending on the type of underlying pathology and severity of injury. However, ∆P levels have also been shown to closely impact hard endpoints such as mortality. Considering this, conducting an in-depth review of ∆P as a unique, outcome-impacting therapeutic modality is extremely important. There is a need to understand the subtleties involved in making sure ∆P levels are optimized to enhance outcomes and minimize harm. We performed this narrative review to further explore the various uses of ∆P, the different parameters that can affect its use, and how outcomes vary in different patient populations at different pressure levels. To better utilize ∆P in MV-requiring patients, additional large-scale clinical studies are needed.
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  • 文章类型: Journal Article
    背景:这项研究的目的是评估将自主呼吸试验(SBT)与压力支持(PS)和呼气末正压(PEEP)以及延长使用拔管后无创通气(NIV)(广泛辅助断奶)的策略是否会缩短成功拔管的时间,与采用T-piece(TP)和拔管后NIV的SBT相比,在选定的患者中提倡的标准断奶标准(难以从机械通气中断奶的患者。
    方法:该研究是单中心前瞻性开放标签,随机对照优势试验,包括两个平行组和1:1比例的平衡随机化。符合条件的患者是机械通气超过24小时的插管患者,这些患者使用TP首次SBT失败。在广泛辅助断奶组中,用PS(7cmH2O)和PEEP(5cmH2O)进行SBT。如果SBT成功,使用TP进行额外的SBT。除其他推荐标准外,该SBT-TP的失败是该组中拔管后NIV的附加标准。在标准断奶组中,用TP进行SBT,根据国际指南进行NIV。主要结果标准是纳入和成功拔管之间的时间,使用Cox模型对随机分层进行调整评估。
    结果:从2019年5月至2023年3月,98例患者被纳入研究并随机分组(每组49例)。4名患者被排除在意向治疗人群之外(两组均为2名);因此,对每组47例患者进行分析。广泛辅助断奶组的中位年龄较高(68[58-73]vs.62[55-71]年。)和相似的性别比例(62%的男性与57%)。在广泛辅助和标准断奶组之间,直到成功拔管的时间没有显着差异(中位数,172[50-436]vs.95[47-232]小时,成功拔管的Cox危险比,0.88[95%置信区间:0.55-1.42],以标准断奶组为参考;p=0.60)。所有次要结果在组间没有显著差异。
    结论:与标准断奶策略相比,广泛辅助断奶策略并没有导致更短的成功拔管时间。试验注册该试验已在ClinicalTrials.gov(NCT03861117)上注册,2019年3月1日,在纳入首例患者之前。https://clinicaltrials.gov/study/NCT03861117.
    BACKGROUND: The aim of this study is to assess whether a strategy combining spontaneous breathing trial (SBT) with both pressure support (PS) and positive end-expiratory pressure (PEEP) and extended use of post-extubation non-invasive ventilation (NIV) (extensively-assisted weaning) would shorten the time until successful extubation as compared with SBT with T-piece (TP) and post-extubation NIV performed in selected patients as advocated by guidelines (standard weaning), in difficult-to-wean patients from mechanical ventilation.
    METHODS: The study is a single-center prospective open label, randomized controlled superiority trial with two parallel groups and balanced randomization with a 1:1 ratio. Eligible patients were intubated patients mechanically ventilated for more than 24 h who failed their first SBT using TP. In the extensively-assisted weaning group, SBT was performed with PS (7 cmH2O) and PEEP (5 cmH2O). In case of SBT success, an additional SBT with TP was performed. Failure of this SBT-TP was an additional criterion for post-extubation NIV in this group in addition to other recommended criteria. In the standard weaning group, SBT was performed with TP, and NIV was performed according to international guidelines. The primary outcome criterion was the time between inclusion and successful extubation evaluated with a Cox model with adjustment on randomization strata.
    RESULTS: From May 2019 to March 2023, 98 patients were included and randomized in the study (49 in each group). Four patients were excluded from the intention-to-treat population (2 in both groups); therefore, 47 patients were analyzed in each group. The extensively-assisted weaning group had a higher median age (68 [58-73] vs. 62 [55-71] yrs.) and similar sex ratio (62% male vs. 57%). Time until successful extubation was not significantly different between extensively-assisted and standard weaning groups (median, 172 [50-436] vs. 95 [47-232] hours, Cox hazard ratio for successful extubation, 0.88 [95% confidence interval: 0.55-1.42] using the standard weaning group as a reference; p = 0.60). All secondary outcomes were not significantly different between groups.
    CONCLUSIONS: An extensively-assisted weaning strategy did not lead to a shorter time to successful extubation than a standard weaning strategy. Trial registration The trial was registered on ClinicalTrials.gov (NCT03861117), on March 1, 2019, before the inclusion of the first patient. https://clinicaltrials.gov/study/NCT03861117 .
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