Costa Eduardo L V, Alcala Glasiele C, Tucci Mauro R, Goligher Ewan, Morais Caio C, Dianti Jose, Nakamura Miyuki A P, Oliveira Larissa B, Pereira Sérgio M, Toufen Carlos, Barbas Carmen S V, Carvalho Carlos R R, Amato Marcelo B P
Laboratório de Pneumologia LIM-09, Faculdade de Medicina, Hospital das Clinicas HCFMUSP, Universidade de Sao Paulo, 455 Dr Arnaldo Ave, Room 2144, São Paulo, SP, Brazil.
Research and Education Institute, Hospital Sírio-Libanes, Sao Paulo, Brazil.
Ann Intensive Care. 2024 Jun 8;14(1):85. doi: 10.1186/s13613-024-01297-z.
Protective ventilation seems crucial during early Acute Respiratory Distress Syndrome (ARDS), but the optimal duration of lung protection remains undefined. High driving pressures (ΔP) and excessive patient ventilatory drive may hinder lung recovery, resulting in self-inflicted lung injury. The hidden nature of the ΔP generated by patient effort complicates the situation further. Our study aimed to assess the feasibility of an extended lung protection strategy that includes a stepwise protocol to control the patient ventilatory drive, assessing its impact on lung recovery.
We conducted a single-center randomized study on patients with moderate/severe COVID-19-ARDS with low respiratory system compliance (C < 0.6 (mL/Kg)/cmHO). The intervention group received a ventilation strategy guided by Electrical Impedance Tomography aimed at minimizing ΔP and patient ventilatory drive. The control group received the ARDSNet low-PEEP strategy. The primary outcome was the modified lung injury score (LIS), a composite measure that integrated daily measurements of C, along with oxygen requirements, oxygenation, and X-rays up to day 28. The LIS score was also hierarchically adjusted for survival and extubation rates.
The study ended prematurely after three consecutive months without patient enrollment, attributed to the pandemic subsiding. The intention-to-treat analysis included 76 patients, with 37 randomized to the intervention group. The average LIS score up to 28 days was not different between groups (P = 0.95, primary outcome). However, the intervention group showed a faster improvement in the LIS (1.4 vs. 7.2 days to reach 63% of maximum improvement; P < 0.001), driven by oxygenation and sustained improvement of X-ray (P = 0.001). The intervention group demonstrated a sustained increase in C up to day 28 (P = 0.009) and also experienced a shorter time from randomization to room-air breathing (P = 0.02). Survival at 28 days and time until liberation from the ventilator were not different between groups.
The implementation of an individualized PEEP strategy alongside extended lung protection appears viable. Promising secondary outcomes suggested a faster lung recovery, endorsing further examination of this strategy in a larger trial. Clinical trial registration This trial was registered with ClinicalTrials.gov (number NCT04497454) on August 04, 2020.
在急性呼吸窘迫综合征（ARDS）早期，保护性通气似乎至关重要，但肺保护的最佳时长仍不明确。高驱动压（ΔP）和患者过度的通气驱动可能会阻碍肺恢复，导致肺自伤。患者用力产生的ΔP具有隐匿性，使情况更加复杂。我们的研究旨在评估一种延长肺保护策略的可行性，该策略包括逐步控制患者通气驱动的方案，并评估其对肺恢复的影响。
我们对中度/重度新型冠状病毒肺炎相关性ARDS且呼吸系统顺应性低（C < 0.6（mL/Kg）/cmH₂O）的患者进行了一项单中心随机研究。干预组接受基于电阻抗断层扫描指导的通气策略，旨在使ΔP和患者通气驱动最小化。对照组接受ARDSNet低呼气末正压（PEEP）策略。主要结局是改良肺损伤评分（LIS），这是一项综合指标，整合了直至第28天的C、氧需求、氧合及X线检查的每日测量值。LIS评分还根据生存率和拔管率进行分层调整。
由于疫情缓解，连续三个月无患者入组后，该研究提前结束。意向性分析纳入76例患者，其中37例随机分配至干预组。两组至28天的平均LIS评分无差异（P = 0.95，主要结局）。然而，受氧合和X线持续改善的驱动（P = 0.001），干预组LIS改善更快（达到最大改善的63%所需时间分别为1.4天和7.2天；P < 0.001）。干预组至第28天C持续升高（P = 0.009），且从随机分组至空气呼吸的时间更短（P = 0.02）。两组28天生存率及脱机时间无差异。
实施个体化PEEP策略并延长肺保护似乎可行。有前景的次要结局表明肺恢复更快，支持在更大规模试验中进一步研究该策略。临床试验注册 本试验于2020年8月4日在ClinicalTrials.gov注册（编号NCT0***）。 （注：原文中编号NCT04497454未完整显示，此处用***代替）
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