First Department of Critical Care Medicine and Pulmonary Services, Evangelismos Hospital, National and Kapodistrian University of Athens Medical School, Athens, Greece.
Department of Otorhinolaryngology-Head and Neck Surgery, University General Hospital of Ioannina, Ioannina, Greece.
Crit Care Explor. 2024 Aug 9;6(8):e1145. doi: 10.1097/CCE.0000000000001145. eCollection 2024 Aug 1.
Optimal timing of tracheostomy in severe traumatic brain injury (TBI) is unknown due to lack of clinical trials. We emulated a target trial to estimate the effect of early vs. delayed tracheostomy strategy on functional outcome of patients with severe TBI.
Target trial emulation using 1:1 balanced risk-set matching.
North American hospitals participating in the TBI Hypertonic Saline randomized controlled trial of the Resuscitation Outcomes Consortium.
The prematching population consisted of patients with TBI and admission Glasgow Coma Scale less than or equal to 8, who were alive and on mechanical ventilation on the fourth day following trial enrollment, and stayed in the ICU for at least 5 days. Patients with absolute indication for tracheostomy and patients who died during the first 28 days with a decision to withdraw care were excluded.
We matched patients who received tracheostomy at a certain timepoint (early group) with patients who had not received tracheostomy at the same timepoint but were at-risk of tracheostomy in the future (delayed group). The primary outcome was a poor 6-month functional outcome, defined as Glasgow Outcome Scale-Extended less than or equal to 4.
Out of 1282 patients available for analysis, 275 comprised the prematching population, with 75 pairs being created postmatching. Median time of tracheostomy differed significantly in the early vs. the delayed group (7.0 d [6.0-10.0 d] vs. 12.0 d [9.8-18.3 d]; p < 0.001). Only 40% of patients in the delayed group received tracheostomy. There was no statistically significant difference between groups regarding poor 6-month functional outcome (early: 68.0% vs. delayed: 72.0%; p = 0.593).
In a target trial emulation, early as opposed to delayed tracheostomy strategy was not associated with differences in 6-month functional outcome following severe TBI. Considering the limitations of target trial emulations, delaying tracheostomy through a "watchful waiting" approach may be appropriate.
由于缺乏临床试验，严重创伤性脑损伤（TBI）患者气管切开的最佳时机仍不清楚。本研究通过模拟目标试验来估计早期与延迟气管切开策略对严重 TBI 患者功能结局的影响。
采用 1:1 平衡风险集匹配的目标试验模拟。
北美参与复苏结果联盟 TBI 高渗盐水随机对照试验的医院。
在匹配前人群中，TBI 患者格拉斯哥昏迷量表评分≤8 分，在试验入组后第 4 天存活且接受机械通气，在 ICU 中至少停留 5 天。绝对需要气管切开的患者以及在 28 天内死亡且决定停止治疗的患者被排除在外。
我们将在特定时间点接受气管切开的患者（早期组）与在同一时间点未接受气管切开但未来有气管切开风险的患者（延迟组）进行匹配。主要结局是 6 个月时功能结局不良，定义为格拉斯哥结局量表扩展评分≤4 分。
在可用于分析的 1282 例患者中，275 例构成匹配前人群，匹配后创建了 75 对。早期组与延迟组的气管切开中位时间差异有统计学意义（7.0 d [6.0-10.0 d] vs. 12.0 d [9.8-18.3 d]；p<0.001）。只有 40%的延迟组患者接受了气管切开。两组间 6 个月时功能结局不良的发生率差异无统计学意义（早期：68.0% vs. 延迟：72.0%；p=0.593）。
在目标试验模拟中，与延迟气管切开策略相比，早期气管切开策略与严重 TBI 后 6 个月的功能结局无差异。考虑到目标试验模拟的局限性，通过“静观其变”的方法延迟气管切开可能是合适的。
