Patel Bhakti K, Wolfe Krysta S, Patel Shruti B, Dugan Karen C, Esbrook Cheryl L, Pawlik Amy J, Stulberg Megan, Kemple Crystal, Teele Megan, Zeleny Erin, Hedeker Donald, Pohlman Anne S, Arora Vineet M, Hall Jesse B, Kress John P
Section of Pulmonary and Critical Care, Department of Medicine, University of Chicago, Chicago, IL, USA.
Loyola University Chicago Stritch School of Medicine, Department of Medicine, Division of Pulmonary/Critical Care, Maywood, IL, USA.
Lancet Respir Med. 2023 Jun;11(6):563-572. doi: 10.1016/S2213-2600(22)00489-1. Epub 2023 Jan 21.
Patients who have received mechanical ventilation can have prolonged cognitive impairment for which there is no known treatment. We aimed to establish whether early mobilisation could reduce the rates of cognitive impairment and other aspects of disability 1 year after critical illness.
In this single-centre, parallel, randomised controlled trial, patients admitted to the adult medical-surgical intensive-care unit (ICU), at the University of Chicago (IL, USA), were recruited. Inclusion criteria were adult patients (aged ≥18 years) who were functionally independent and mechanically ventilated at baseline and within the first 96 h of mechanical ventilation, and expected to continue for at least 24 h. Patients were randomly assigned (1:1) via computer-generated permuted balanced block randomisation to early physical and occupational therapy (early mobilisation) or usual care. An investigator designated each assignment in consecutively numbered, sealed, opaque envelopes; they had no further involvement in the trial. Only the assessors were masked to group assignment. The primary outcome was cognitive impairment 1 year after hospital discharge, measured with a Montreal Cognitive Assessment. Patients were assessed for cognitive impairment, neuromuscular weakness, institution-free days, functional independence, and quality of life at hospital discharge and 1 year. Analysis was by intention to treat. This trial was registered with ClinicalTrials.gov, number NCT01777035, and is now completed.
Between Aug 11, 2011, and Oct 24, 2019, 1222 patients were screened, 200 were enrolled (usual care n=100, intervention n=100), and one patient withdrew from the study in each group; thus 99 patients in each group were included in the intention-to-treat analysis (113 [57%] men and 85 [43%] women). 65 (88%) of 74 in the usual care group and 62 (89%) of 70 in the intervention group underwent testing for cognitive impairment at 1 year. The rate of cognitive impairment at 1 year with early mobilisation was 24% (24 of 99 patients) compared with 43% (43 of 99) with usual care (absolute difference -19·2%, 95% CI -32·1 to -6·3%; p=0·0043). Cognitive impairment was lower at hospital discharge in the intervention group (53 [54%] 99 patients vs 68 [69%] 99 patients; -15·2%, -28·6 to -1·7; p=0·029). At 1 year, the intervention group had fewer ICU-acquired weaknesses (none [0%] of 99 patients vs 14 [14%] of 99 patients; -14·1%; -21·0 to -7·3; p=0·0001) and higher physical component scores on quality-of-life testing than did the usual care group (median 52·4 [IQR 45·3-56·8] vs median 41·1 [31·8-49·4]; p<0·0001). There was no difference in the rates of functional independence (64 [65%] of 99 patients vs 61 [62%] of 99 patients; 3%, -10·4 to 16·5%; p=0·66) or mental component scores (median 55·9 [50·2-58·9] vs median 55·2 [49·5-59·7]; p=0·98) between the intervention and usual care groups at 1 year. Seven adverse events (haemodynamic changes [n=3], arterial catheter removal [n=1], rectal tube dislodgement [n=1], and respiratory distress [n=2]) were reported in six (6%) of 99 patients in the intervention group and in none of the patients in the usual care group (p=0·029).
Early mobilisation might be the first known intervention to improve long-term cognitive impairment in ICU survivors after mechanical ventilation. These findings clearly emphasise the importance of avoiding delays in initiating mobilisation. However, the increased adverse events in the intervention group warrants further investigation to replicate these findings.
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接受机械通气的患者可能会出现长期认知障碍，目前尚无已知的治疗方法。我们旨在确定早期活动是否可以降低危重病后1年的认知障碍发生率及其他残疾方面的发生率。
在这项单中心、平行、随机对照试验中，招募了美国伊利诺伊州芝加哥大学成人内科-外科重症监护病房（ICU）收治的患者。纳入标准为成年患者（年龄≥18岁），基线时功能独立且在机械通气的前96小时内接受机械通气，预计持续至少24小时。患者通过计算机生成的置换平衡区组随机化以1:1的比例随机分配至早期物理和职业治疗（早期活动）或常规护理组。一名研究者将每个分配方案放入连续编号、密封、不透明的信封中；他们不再参与试验。只有评估者对分组情况不知情。主要结局是出院1年后的认知障碍，采用蒙特利尔认知评估量表进行测量。在出院时和1年时对患者进行认知障碍、神经肌肉无力、无机构护理天数、功能独立性和生活质量评估。分析采用意向性分析。本试验已在ClinicalTrials.gov注册，编号为NCT01777035，现已完成。
2011年8月11日至2019年10月24日期间，共筛选了1222例患者，200例入组（常规护理组100例，干预组100例），每组各有1例患者退出研究；因此，每组99例患者纳入意向性分析（男性113例[57%]，女性85例[43%]）。常规护理组74例中的65例（88%）和干预组70例中的62例（89%）在1年时接受了认知障碍测试。早期活动组1年时的认知障碍发生率为24%（99例患者中的24例），而常规护理组为43%（99例中的43例）（绝对差异-19.2%，95%CI -32.1至-6.3%；p=0.0043）。干预组出院时的认知障碍发生率较低（99例患者中的53例[54%] vs 99例患者中的68例[69%]；-15.2%，-28.6至-1.7；p=0.029）。1年时，干预组的ICU获得性虚弱较少（99例患者中无[0%] vs 99例患者中的14例[14%]；-14.1%；-21.0至-7.3；p=0.0001），且生活质量测试中的身体成分得分高于常规护理组（中位数52.4[IQR 45.3 - 56.8] vs中位数41.1[31.8 - 49.4]；p<0.0001）。干预组和常规护理组在1年时的功能独立性发生率（99例患者中的64例[65%] vs 99例患者中的61例[62%]；3%，-10.4至16.5%；p=0.66）或精神成分得分（中位数55.9[50.2 - 58.9] vs中位数55.2[49.5 - 59.7]；p=0.98）没有差异。干预组99例患者中有6例（6%）报告了7起不良事件（血流动力学变化[n = 3]、动脉导管拔除[n = 1]、直肠管移位[n = 1]和呼吸窘迫[n = 2]），常规护理组患者均未报告（p=0.029）。
早期活动可能是已知的首个改善机械通气后ICU幸存者长期认知障碍的干预措施。这些发现明确强调了避免延迟开始活动的重要性。然而，干预组不良事件增加值得进一步研究以重复这些发现。
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