{"title":"无肌肉麻痹全麻期间高流量鼻氧与喉罩机械通气:一项随机临床试验。","authors":"Luciano Frassanito,Domenico Luca Grieco,Francesco Vassalli,Alessandra Piersanti,Marco Scorzoni,Francesca Ciano,Bruno Antonio Zanfini,Stefano Catarci,Ursula Catena,Giovanni Scambia,Massimo Antonelli,Gaetano Draisci","doi":"10.1213/ane.0000000000007620","DOIUrl":null,"url":null,"abstract":"BACKGROUND\r\nApneic oxygenation with high-flow nasal oxygen is a novel intraoperative respiratory support strategy for patients undergoing general anesthesia, but data about its clinical effects are scarce. We conducted a randomized trial to assess whether high-flow nasal oxygen is noninferior to mechanical ventilation through a laryngeal mask in terms of success rate of intraoperative respiratory support among patients undergoing a 30-minute general anesthesia session.\r\n\r\nMETHODS\r\nSingle-center, randomized, noninferiority trial conducted in Italy between May 2022 and June 2023 and involving American Society of Anesthesiologists class I and II patients undergoing general anesthesia for operative hysteroscopy. Participants were randomized to receive laryngeal mask ventilation (volume-controlled ventilation to obtain end-tidal carbon dioxide between 35 and 45 mm Hg, inhaled oxygen fraction to achieve peripheral oxygen saturation greater than 95%) or high-flow nasal oxygen (70 L per minute, inhaled oxygen fraction of 100%) for intraoperative respiratory support. Patients received general anesthesia with propofol target-controlled infusion without neuromuscular blockade. Primary outcome was intraoperative respiratory support success rate, which was defined as peripheral oxygen saturation greater than 94% and transcutaneous carbon dioxide lower than 65 mm Hg with no need for rescue airway interventions for the entire procedure. Secondary outcomes included the rate of airway-related complications (including need for bag-mask or laryngeal mask ventilation, or tracheal intubation), postoperative respiratory symptoms, and postoperative dyspnea.\r\n\r\nRESULTS\r\nAll 180 patients who were randomized completed the trial (90 patients in each group). Median [interquartile range] anesthesia duration was 25 [20-36] minutes in high-flow group and 32 minutes [27-44] in the laryngeal mask group. Intraoperative respiratory support was successful in 89 patients (99%) in both groups (absolute difference 0, unilateral 95% confidence interval, 3%, noninferiority P < .001). Incidence of postoperative respiratory symptoms was significantly lower in high-flow versus laryngeal mask group (2% vs 19%, P < .001), while airway-related complications and postoperative dyspnea were not different. Intraoperative transcutaneous carbon dioxide was significantly higher in high-flow group, with 43% of patients showing values greater than 55 mm Hg.\r\n\r\nCONCLUSIONS\r\nHigh-flow nasal oxygen is noninferior to laryngeal mask ventilation for intraoperative respiratory support during 30-minute general anesthesia without muscle paralysis. The risk of hypercarbia warrants careful patient selection and monitoring.","PeriodicalId":7799,"journal":{"name":"Anesthesia & Analgesia","volume":"110 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2025-07-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"High-Flow Nasal Oxygen versus Mechanical Ventilation Through a Laryngeal Mask During General Anesthesia Without Muscle Paralysis: A Randomized Clinical Trial.\",\"authors\":\"Luciano Frassanito,Domenico Luca Grieco,Francesco Vassalli,Alessandra Piersanti,Marco Scorzoni,Francesca Ciano,Bruno Antonio Zanfini,Stefano Catarci,Ursula Catena,Giovanni Scambia,Massimo Antonelli,Gaetano Draisci\",\"doi\":\"10.1213/ane.0000000000007620\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"BACKGROUND\\r\\nApneic oxygenation with high-flow nasal oxygen is a novel intraoperative respiratory support strategy for patients undergoing general anesthesia, but data about its clinical effects are scarce. We conducted a randomized trial to assess whether high-flow nasal oxygen is noninferior to mechanical ventilation through a laryngeal mask in terms of success rate of intraoperative respiratory support among patients undergoing a 30-minute general anesthesia session.\\r\\n\\r\\nMETHODS\\r\\nSingle-center, randomized, noninferiority trial conducted in Italy between May 2022 and June 2023 and involving American Society of Anesthesiologists class I and II patients undergoing general anesthesia for operative hysteroscopy. Participants were randomized to receive laryngeal mask ventilation (volume-controlled ventilation to obtain end-tidal carbon dioxide between 35 and 45 mm Hg, inhaled oxygen fraction to achieve peripheral oxygen saturation greater than 95%) or high-flow nasal oxygen (70 L per minute, inhaled oxygen fraction of 100%) for intraoperative respiratory support. Patients received general anesthesia with propofol target-controlled infusion without neuromuscular blockade. Primary outcome was intraoperative respiratory support success rate, which was defined as peripheral oxygen saturation greater than 94% and transcutaneous carbon dioxide lower than 65 mm Hg with no need for rescue airway interventions for the entire procedure. Secondary outcomes included the rate of airway-related complications (including need for bag-mask or laryngeal mask ventilation, or tracheal intubation), postoperative respiratory symptoms, and postoperative dyspnea.\\r\\n\\r\\nRESULTS\\r\\nAll 180 patients who were randomized completed the trial (90 patients in each group). Median [interquartile range] anesthesia duration was 25 [20-36] minutes in high-flow group and 32 minutes [27-44] in the laryngeal mask group. Intraoperative respiratory support was successful in 89 patients (99%) in both groups (absolute difference 0, unilateral 95% confidence interval, 3%, noninferiority P < .001). Incidence of postoperative respiratory symptoms was significantly lower in high-flow versus laryngeal mask group (2% vs 19%, P < .001), while airway-related complications and postoperative dyspnea were not different. Intraoperative transcutaneous carbon dioxide was significantly higher in high-flow group, with 43% of patients showing values greater than 55 mm Hg.\\r\\n\\r\\nCONCLUSIONS\\r\\nHigh-flow nasal oxygen is noninferior to laryngeal mask ventilation for intraoperative respiratory support during 30-minute general anesthesia without muscle paralysis. The risk of hypercarbia warrants careful patient selection and monitoring.\",\"PeriodicalId\":7799,\"journal\":{\"name\":\"Anesthesia & Analgesia\",\"volume\":\"110 1\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2025-07-21\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Anesthesia & Analgesia\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1213/ane.0000000000007620\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Anesthesia & Analgesia","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1213/ane.0000000000007620","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
摘要
背景:高流量鼻氧通气是全麻患者术中一种新颖的呼吸支持策略,但其临床效果的数据很少。我们进行了一项随机试验,以评估在接受30分钟全身麻醉的患者中,高流量鼻氧是否优于通过喉罩进行机械通气的术中呼吸支持成功率。方法:于2022年5月至2023年6月在意大利进行的一项单中心、随机、非劣效性试验,纳入美国麻醉医师学会I级和II级全麻手术宫腔镜患者。参与者随机接受喉罩通气(容量控制通气以获得潮末二氧化碳在35 - 45 mm Hg之间,吸入氧分数达到外周氧饱和度大于95%)或高流量鼻氧(每分钟70 L,吸入氧分数100%)用于术中呼吸支持。患者接受异丙酚靶控输注全麻,无神经肌肉阻滞。主要终点是术中呼吸支持成功率,其定义为外周氧饱和度大于94%,经皮二氧化碳低于65 mm Hg,整个手术过程无需气道急救干预。次要结局包括气道相关并发症的发生率(包括需要气囊面罩或喉罩通气,或气管插管)、术后呼吸症状和术后呼吸困难。结果180例患者全部完成试验(每组90例)。高流量组麻醉时间中位数[四分位数间距]为25[20-36]分钟,喉罩组麻醉时间中位数[27-44]分钟。两组患者术中呼吸支持均成功89例(99%)(绝对差值为0,单侧95%可信区间为3%,非效性P < 0.001)。高流量组术后呼吸道症状发生率明显低于喉罩组(2% vs 19%, P < 0.001),气道相关并发症及术后呼吸困难发生率无显著差异。高流量组术中经皮二氧化碳值明显升高,43%患者大于55mmhg。结论在30分钟全麻无肌肉麻痹的情况下,高流量鼻吸氧在术中呼吸支持方面不逊色于喉罩通气。高碳酸血症的风险需要谨慎的患者选择和监测。
High-Flow Nasal Oxygen versus Mechanical Ventilation Through a Laryngeal Mask During General Anesthesia Without Muscle Paralysis: A Randomized Clinical Trial.
BACKGROUND
Apneic oxygenation with high-flow nasal oxygen is a novel intraoperative respiratory support strategy for patients undergoing general anesthesia, but data about its clinical effects are scarce. We conducted a randomized trial to assess whether high-flow nasal oxygen is noninferior to mechanical ventilation through a laryngeal mask in terms of success rate of intraoperative respiratory support among patients undergoing a 30-minute general anesthesia session.
METHODS
Single-center, randomized, noninferiority trial conducted in Italy between May 2022 and June 2023 and involving American Society of Anesthesiologists class I and II patients undergoing general anesthesia for operative hysteroscopy. Participants were randomized to receive laryngeal mask ventilation (volume-controlled ventilation to obtain end-tidal carbon dioxide between 35 and 45 mm Hg, inhaled oxygen fraction to achieve peripheral oxygen saturation greater than 95%) or high-flow nasal oxygen (70 L per minute, inhaled oxygen fraction of 100%) for intraoperative respiratory support. Patients received general anesthesia with propofol target-controlled infusion without neuromuscular blockade. Primary outcome was intraoperative respiratory support success rate, which was defined as peripheral oxygen saturation greater than 94% and transcutaneous carbon dioxide lower than 65 mm Hg with no need for rescue airway interventions for the entire procedure. Secondary outcomes included the rate of airway-related complications (including need for bag-mask or laryngeal mask ventilation, or tracheal intubation), postoperative respiratory symptoms, and postoperative dyspnea.
RESULTS
All 180 patients who were randomized completed the trial (90 patients in each group). Median [interquartile range] anesthesia duration was 25 [20-36] minutes in high-flow group and 32 minutes [27-44] in the laryngeal mask group. Intraoperative respiratory support was successful in 89 patients (99%) in both groups (absolute difference 0, unilateral 95% confidence interval, 3%, noninferiority P < .001). Incidence of postoperative respiratory symptoms was significantly lower in high-flow versus laryngeal mask group (2% vs 19%, P < .001), while airway-related complications and postoperative dyspnea were not different. Intraoperative transcutaneous carbon dioxide was significantly higher in high-flow group, with 43% of patients showing values greater than 55 mm Hg.
CONCLUSIONS
High-flow nasal oxygen is noninferior to laryngeal mask ventilation for intraoperative respiratory support during 30-minute general anesthesia without muscle paralysis. The risk of hypercarbia warrants careful patient selection and monitoring.