肺健康志愿者有或没有呼气末正压预充氧:一项随机临床试验

IF 10.5 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL
Giulia Roveri, Anna Camporesi, Alex Hofer, Simon Kahlen, Franziska Breidt, Simon Rauch
{"title":"肺健康志愿者有或没有呼气末正压预充氧:一项随机临床试验","authors":"Giulia Roveri, Anna Camporesi, Alex Hofer, Simon Kahlen, Franziska Breidt, Simon Rauch","doi":"10.1001/jamanetworkopen.2025.11569","DOIUrl":null,"url":null,"abstract":"<p><strong>Importance: </strong>Optimal preoxygenation is critical in emergency medicine to prevent desaturation during airway management, especially in high-risk populations. Identifying the most effective preoxygenation device across diverse patient groups remains a clinical priority.</p><p><strong>Objective: </strong>To compare the efficacy of 3 preoxygenation devices-nonrebreather mask (NRM), bag-valve mask (BVM), and BVM with positive end-expiratory pressure (BVM plus PEEP)-in lung-healthy volunteers.</p><p><strong>Design, setting, and participants: </strong>This crossover randomized clinical trial was conducted from May 26 to 31, 2024, at Eurac Research, Bolzano, Italy. Volunteer participants included lung-healthy adults with normal weight (NM), adults with overweight or obesity (OW-OB), and children aged 6 to 12 years.</p><p><strong>Exposures: </strong>Preoxygenation using each device (NRM, BVM, BVM plus PEEP) with 15 L/min of oxygen for a duration of 3 minutes in a randomized order.</p><p><strong>Main outcomes and measures: </strong>The primary outcome was expiratory oxygen concentration (Feo2) at the end of preoxygenation. Secondary outcomes included ventilation in dependent lung regions assessed using electrical impedance tomography, noninvasive continuous monitoring of oxygenation status (oxygenation reserve index [ORI]) at the end of preoxygenation, and the time taken for ORI to return to baseline values.</p><p><strong>Results: </strong>The study included 53 participants, 39 male (74%) and 14 female (26%), of whom 16 were adults with NW (mean [SD] age, 36 [11] years), 18 were adults with OW-OB (mean [SD] age, 45 [11] years), and 19 were children (mean [SD] age, 8 [3] years). Mean (SD) Feo2 at the end of preoxygenation was higher with BVM and BVM plus PEEP compared with NRM in adults with NW (72.1% [5.9%] and 75.6% [4.3%], respectively, vs 52.5% [6.1%]; P < .001), adults with OW-OB (65.8% [10.4%] and 73.0% [6.4%], respectively, vs 51.9% [6.1%]; P < .001), and children (64.6% [13.4%] and 67.5% [10.2%], respectively, vs 38.5% [7.5%]; P < .001). Ventilation in dependent lung regions was higher with BVM plus PEEP than NRM in adults with NW (BVM plus PEEP, 51.9 [9.3] vs NRM, 47.0 [5.7]; P = .03) and children (BVM plus PEEP, 53.0 [7.3] vs NRM, 47.7 [7.0]; P = .002). ORI at the end of preoxygenation was higher with BVM plus PEEP than with NRM in adults with OW-OB (BVM plus PEEP, 0.79 [0.13] vs NRM, 0.73 [0.13]; P < .001). Additionally, the mean (SE) time for ORI to return to baseline was longer with BVM plus PEEP compared with NRM in both adults with OW-OB (BVM plus PEEP, 196 [74] seconds vs NRM, 158 [53] seconds; P = .01) and children (BVM plus PEEP, 115 [59] seconds vs NRM, 62 [36] seconds; P < .001).</p><p><strong>Conclusions and relevance: </strong>In this crossover randomized clinical trial, preoxygenation with PEEP was more effective than preoxygenation without PEEP, resulting in higher Feo2 values and improved ventilation in dependent lung regions. These findings suggest that BVM plus PEEP should be prioritized for preoxygenation in emergency settings.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT06370689.</p>","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 5","pages":"e2511569"},"PeriodicalIF":10.5000,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12093187/pdf/","citationCount":"0","resultStr":"{\"title\":\"Preoxygenation With and Without Positive End-Expiratory Pressure in Lung-Healthy Volunteers: A Randomized Clinical Trial.\",\"authors\":\"Giulia Roveri, Anna Camporesi, Alex Hofer, Simon Kahlen, Franziska Breidt, Simon Rauch\",\"doi\":\"10.1001/jamanetworkopen.2025.11569\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Importance: </strong>Optimal preoxygenation is critical in emergency medicine to prevent desaturation during airway management, especially in high-risk populations. Identifying the most effective preoxygenation device across diverse patient groups remains a clinical priority.</p><p><strong>Objective: </strong>To compare the efficacy of 3 preoxygenation devices-nonrebreather mask (NRM), bag-valve mask (BVM), and BVM with positive end-expiratory pressure (BVM plus PEEP)-in lung-healthy volunteers.</p><p><strong>Design, setting, and participants: </strong>This crossover randomized clinical trial was conducted from May 26 to 31, 2024, at Eurac Research, Bolzano, Italy. Volunteer participants included lung-healthy adults with normal weight (NM), adults with overweight or obesity (OW-OB), and children aged 6 to 12 years.</p><p><strong>Exposures: </strong>Preoxygenation using each device (NRM, BVM, BVM plus PEEP) with 15 L/min of oxygen for a duration of 3 minutes in a randomized order.</p><p><strong>Main outcomes and measures: </strong>The primary outcome was expiratory oxygen concentration (Feo2) at the end of preoxygenation. Secondary outcomes included ventilation in dependent lung regions assessed using electrical impedance tomography, noninvasive continuous monitoring of oxygenation status (oxygenation reserve index [ORI]) at the end of preoxygenation, and the time taken for ORI to return to baseline values.</p><p><strong>Results: </strong>The study included 53 participants, 39 male (74%) and 14 female (26%), of whom 16 were adults with NW (mean [SD] age, 36 [11] years), 18 were adults with OW-OB (mean [SD] age, 45 [11] years), and 19 were children (mean [SD] age, 8 [3] years). Mean (SD) Feo2 at the end of preoxygenation was higher with BVM and BVM plus PEEP compared with NRM in adults with NW (72.1% [5.9%] and 75.6% [4.3%], respectively, vs 52.5% [6.1%]; P < .001), adults with OW-OB (65.8% [10.4%] and 73.0% [6.4%], respectively, vs 51.9% [6.1%]; P < .001), and children (64.6% [13.4%] and 67.5% [10.2%], respectively, vs 38.5% [7.5%]; P < .001). Ventilation in dependent lung regions was higher with BVM plus PEEP than NRM in adults with NW (BVM plus PEEP, 51.9 [9.3] vs NRM, 47.0 [5.7]; P = .03) and children (BVM plus PEEP, 53.0 [7.3] vs NRM, 47.7 [7.0]; P = .002). ORI at the end of preoxygenation was higher with BVM plus PEEP than with NRM in adults with OW-OB (BVM plus PEEP, 0.79 [0.13] vs NRM, 0.73 [0.13]; P < .001). Additionally, the mean (SE) time for ORI to return to baseline was longer with BVM plus PEEP compared with NRM in both adults with OW-OB (BVM plus PEEP, 196 [74] seconds vs NRM, 158 [53] seconds; P = .01) and children (BVM plus PEEP, 115 [59] seconds vs NRM, 62 [36] seconds; P < .001).</p><p><strong>Conclusions and relevance: </strong>In this crossover randomized clinical trial, preoxygenation with PEEP was more effective than preoxygenation without PEEP, resulting in higher Feo2 values and improved ventilation in dependent lung regions. These findings suggest that BVM plus PEEP should be prioritized for preoxygenation in emergency settings.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT06370689.</p>\",\"PeriodicalId\":14694,\"journal\":{\"name\":\"JAMA Network Open\",\"volume\":\"8 5\",\"pages\":\"e2511569\"},\"PeriodicalIF\":10.5000,\"publicationDate\":\"2025-05-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12093187/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"JAMA Network Open\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1001/jamanetworkopen.2025.11569\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"JAMA Network Open","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1001/jamanetworkopen.2025.11569","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
引用次数: 0

摘要

重要性:最佳预充氧在急诊医学中至关重要,以防止气道管理过程中的失饱和,特别是在高危人群中。在不同的患者群体中确定最有效的预充氧装置仍然是临床优先考虑的问题。目的:比较非呼吸面罩(NRM)、袋阀面罩(BVM)和呼气末正压面罩(BVM + PEEP) 3种预充氧装置在肺健康志愿者中的应用效果。设计、环境和参与者:该交叉随机临床试验于2024年5月26日至31日在意大利博尔扎诺的Eurac研究中心进行。志愿者包括正常体重的肺健康成年人(NM),超重或肥胖的成年人(low - ob),以及6至12岁的儿童。暴露:使用每个设备(NRM, BVM, BVM加PEEP)以15l /min的氧气预充氧,以随机顺序持续3分钟。主要观察指标:主要观察指标为预充氧结束时呼气氧浓度(Feo2)。次要结果包括使用电阻抗断层扫描评估依赖肺区域的通气,预充氧结束时无创连续监测氧合状态(氧合储备指数[ORI]),以及ORI恢复到基线值所需的时间。结果:共纳入53例受试者,其中男性39例(74%),女性14例(26%),其中成人NW 16例(平均[SD]年龄36岁),成人低ob 18例(平均[SD]年龄45岁),儿童19例(平均[SD]年龄8岁)。与NW患者相比,BVM和BVM + PEEP预充氧结束时的平均(SD) Feo2高于NRM(分别为72.1%[5.9%]和75.6% [4.3%]);结论及相关性:在这项交叉随机临床试验中,有PEEP预充氧比无PEEP预充氧更有效,可导致更高的Feo2值并改善依赖肺区域的通气。这些发现表明,在紧急情况下,BVM + PEEP应优先用于预充氧。试验注册:ClinicalTrials.gov标识符:NCT06370689。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Preoxygenation With and Without Positive End-Expiratory Pressure in Lung-Healthy Volunteers: A Randomized Clinical Trial.

Importance: Optimal preoxygenation is critical in emergency medicine to prevent desaturation during airway management, especially in high-risk populations. Identifying the most effective preoxygenation device across diverse patient groups remains a clinical priority.

Objective: To compare the efficacy of 3 preoxygenation devices-nonrebreather mask (NRM), bag-valve mask (BVM), and BVM with positive end-expiratory pressure (BVM plus PEEP)-in lung-healthy volunteers.

Design, setting, and participants: This crossover randomized clinical trial was conducted from May 26 to 31, 2024, at Eurac Research, Bolzano, Italy. Volunteer participants included lung-healthy adults with normal weight (NM), adults with overweight or obesity (OW-OB), and children aged 6 to 12 years.

Exposures: Preoxygenation using each device (NRM, BVM, BVM plus PEEP) with 15 L/min of oxygen for a duration of 3 minutes in a randomized order.

Main outcomes and measures: The primary outcome was expiratory oxygen concentration (Feo2) at the end of preoxygenation. Secondary outcomes included ventilation in dependent lung regions assessed using electrical impedance tomography, noninvasive continuous monitoring of oxygenation status (oxygenation reserve index [ORI]) at the end of preoxygenation, and the time taken for ORI to return to baseline values.

Results: The study included 53 participants, 39 male (74%) and 14 female (26%), of whom 16 were adults with NW (mean [SD] age, 36 [11] years), 18 were adults with OW-OB (mean [SD] age, 45 [11] years), and 19 were children (mean [SD] age, 8 [3] years). Mean (SD) Feo2 at the end of preoxygenation was higher with BVM and BVM plus PEEP compared with NRM in adults with NW (72.1% [5.9%] and 75.6% [4.3%], respectively, vs 52.5% [6.1%]; P < .001), adults with OW-OB (65.8% [10.4%] and 73.0% [6.4%], respectively, vs 51.9% [6.1%]; P < .001), and children (64.6% [13.4%] and 67.5% [10.2%], respectively, vs 38.5% [7.5%]; P < .001). Ventilation in dependent lung regions was higher with BVM plus PEEP than NRM in adults with NW (BVM plus PEEP, 51.9 [9.3] vs NRM, 47.0 [5.7]; P = .03) and children (BVM plus PEEP, 53.0 [7.3] vs NRM, 47.7 [7.0]; P = .002). ORI at the end of preoxygenation was higher with BVM plus PEEP than with NRM in adults with OW-OB (BVM plus PEEP, 0.79 [0.13] vs NRM, 0.73 [0.13]; P < .001). Additionally, the mean (SE) time for ORI to return to baseline was longer with BVM plus PEEP compared with NRM in both adults with OW-OB (BVM plus PEEP, 196 [74] seconds vs NRM, 158 [53] seconds; P = .01) and children (BVM plus PEEP, 115 [59] seconds vs NRM, 62 [36] seconds; P < .001).

Conclusions and relevance: In this crossover randomized clinical trial, preoxygenation with PEEP was more effective than preoxygenation without PEEP, resulting in higher Feo2 values and improved ventilation in dependent lung regions. These findings suggest that BVM plus PEEP should be prioritized for preoxygenation in emergency settings.

Trial registration: ClinicalTrials.gov Identifier: NCT06370689.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
JAMA Network Open
JAMA Network Open Medicine-General Medicine
CiteScore
16.00
自引率
2.90%
发文量
2126
审稿时长
16 weeks
期刊介绍: JAMA Network Open, a member of the esteemed JAMA Network, stands as an international, peer-reviewed, open-access general medical journal.The publication is dedicated to disseminating research across various health disciplines and countries, encompassing clinical care, innovation in health care, health policy, and global health. JAMA Network Open caters to clinicians, investigators, and policymakers, providing a platform for valuable insights and advancements in the medical field. As part of the JAMA Network, a consortium of peer-reviewed general medical and specialty publications, JAMA Network Open contributes to the collective knowledge and understanding within the medical community.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信