Bar Stéphane, Moussa Mouhamed Djahoum, Descamps Richard, El Amine Younes, Bouhemad Belaid, Fischer Marc-Olivier, Lorne Emmanuel, Dupont Hervé, Diouf Momar, Guinot Pierre Grégoire
Department of Anaesthesiology and Critical Care Medicine, Amiens University Medical Centre, Amiens, France; SSPC UPJV 7518 (Simplifications des Soins Patients Chirurgicaux Complexes - Simplification of Care of Complex Surgical Patients) Clinical Research Unit, Jules Verne University of Picardie, Amiens, France.
Department of Anaesthesiology and Critical Care Medicine, Lille University Medical Centre, Lille, France.
Anaesth Crit Care Pain Med. 2023 Aug;42(4):101221. doi: 10.1016/j.accpm.2023.101221. Epub 2023 Mar 21.
There is a need to develop non-invasive markers to identify the occurrence of anaerobic metabolism in high-risk surgery. Our objective was to demonstrate that a goal-directed therapy algorithm incorporating the respiratory exchange ratio (ratio between CO production and O consumption) can reduce postoperative complications.
We conducted a randomized, multicenter, controlled clinical trial in four university medical centers and one non-university hospital from December 26, 2018, to September 9, 2021. 350 patients with a high risk of postoperative complications undergoing high-risk noncardiac surgery lasting 2 h or longer under general anesthesia were enrolled. The control group was treated according to current hemodynamic guidelines. The interventional group was treated according to an algorithm based on the measurement of the respiratory exchange ratio. The primary outcome was a composite of major complications or death within seven days of surgery. The secondary outcomes were the length of hospital stay, 30-day mortality, and the total intraoperative volume of fluids administered.
The primary outcome occurred for 78 patients (45.6%) in the interventional group and 83 patients (48.8%) in the control group (relative risk: 0.93, 95% confidence interval [CI]: 0.75-1.17; p = 0.55). There were no clinically relevant differences between the two groups for secondary outcomes.
In high-risk surgery, a goal-directed therapy algorithm integrating the measurement of the respiratory-exchange ratio did not reduce a composite outcome of major postoperative complications or death within seven days after surgery compared to routine care.
ClinicalTrials.gov, NCT03852147.
需要开发非侵入性标志物来识别高危手术中无氧代谢的发生情况。我们的目标是证明一种纳入呼吸交换率（二氧化碳产生量与氧气消耗量之比）的目标导向治疗算法可减少术后并发症。
我们于2018年12月26日至202I年9月9日在4所大学医学中心和1所非大学医院进行了一项随机、多中心、对照临床试验。纳入350例接受全身麻醉、持续2小时或更长时间的高危非心脏手术且术后并发症风险高的患者。对照组按照当前的血流动力学指南进行治疗。干预组根据基于呼吸交换率测量的算法进行治疗。主要结局是术后7天内主要并发症或死亡的复合结局。次要结局是住院时间、30天死亡率和术中补液总量。
干预组78例患者（45.6%）出现主要结局，对照组83例患者（48.8%）出现主要结局（相对风险：0.93，95%置信区间[CI]：0.75 - 1.17；p = 0.55）。两组次要结局无临床相关差异。
在高危手术中，与常规治疗相比，整合呼吸交换率测量的目标导向治疗算法并未降低术后7天内主要术后并发症或死亡的复合结局。
ClinicalTrials.gov，NCT03852147。
