Tim R.E. Harris , Zain A. Bhutta , Isma Qureshi , Nadir Kharma , Tasleem Raza , Ali Ait Hssain , Ankush Suresh Pathare , Ashwin D'Silva , Mohamad Yahya Khatib , Mohamed Gafar Hussein Mohamedali , Ignacio Miguel Gomez Macineira , Victor Ramon Garcia Hernandez , Jorge Rosales Garcia , Stephen H. Thomas , Sameer A. Pathan
{"title":"对 COVID-19 嫌疑人急性低氧性呼吸衰竭患者进行清醒俯卧位随机临床试验","authors":"Tim R.E. Harris , Zain A. Bhutta , Isma Qureshi , Nadir Kharma , Tasleem Raza , Ali Ait Hssain , Ankush Suresh Pathare , Ashwin D'Silva , Mohamad Yahya Khatib , Mohamed Gafar Hussein Mohamedali , Ignacio Miguel Gomez Macineira , Victor Ramon Garcia Hernandez , Jorge Rosales Garcia , Stephen H. Thomas , Sameer A. Pathan","doi":"10.1016/j.conctc.2024.101295","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>Awake prone position (APP) has been reported to improve oxygenation in patients with COVID-19 disease and to reduce the requirement for invasive mechanical ventilation for patients requiring support with high flow nasal cannula. There is conflicting data for patients requiring lower-level oxygen support.</p></div><div><h3>Research question</h3><p>Does APP reduce escalation of oxygen support in COVID-19 patients requiring supplementary oxygen?The primary outcome was defined as an escalation of oxygen support from simple supplementary oxygen (NP, HM, NRB) <strong><em>to</em></strong> NIV (CPAP or BiPAP), HFNC or IMV; <strong>OR</strong> from NIV (CPAP or BiPAP) or HFNC <strong><em>to</em></strong> IMV by day30.</p></div><div><h3>Study design</h3><p>Two center, prospective, non-blind, randomised controlled trial. Patients with confirmed or suspected COVID-19 pneumonia requiring ≥ 5 liters/min oxygen to maintain saturations ≥ 94 % were randomised to either APP or control group. The APP group received a 3-h APP session three times per day for three days.</p></div><div><h3>Results</h3><p>Between 9 May and July 13, 2021, 89 adults were screened and 61 enrolled, 31 to awake prone position and 30 controls. There was no difference in the primary outcome, 7 (22.6 %) patients randomised to APP and 9 (30.0 %) controls required escalation of oxygen support (OR 0.68 (0.22–2.14), <em>P</em> = 0.51). There were no differences in any secondary outcomes, in APP did not improve oxygenation.</p></div><div><h3>Interpretation</h3><p>In COVID-19 patients, the use of APP did not prevent escalation of oxygen support from supplementary to invasive or non-invasive ventilation or improve patient respiratory physiology.</p></div><div><h3>Trial registration</h3><p>NCT04853979 (<span>clinicaltrials.gov</span><svg><path></path></svg>).</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"39 ","pages":"Article 101295"},"PeriodicalIF":1.4000,"publicationDate":"2024-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000425/pdfft?md5=c016f723ae0edaae0344f5e1efa745fb&pid=1-s2.0-S2451865424000425-main.pdf","citationCount":"0","resultStr":"{\"title\":\"A randomised clinical trial of awake prone positioning in COVID-19 suspects with acute hypoxemic respiratory failure\",\"authors\":\"Tim R.E. Harris , Zain A. Bhutta , Isma Qureshi , Nadir Kharma , Tasleem Raza , Ali Ait Hssain , Ankush Suresh Pathare , Ashwin D'Silva , Mohamad Yahya Khatib , Mohamed Gafar Hussein Mohamedali , Ignacio Miguel Gomez Macineira , Victor Ramon Garcia Hernandez , Jorge Rosales Garcia , Stephen H. Thomas , Sameer A. Pathan\",\"doi\":\"10.1016/j.conctc.2024.101295\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>Awake prone position (APP) has been reported to improve oxygenation in patients with COVID-19 disease and to reduce the requirement for invasive mechanical ventilation for patients requiring support with high flow nasal cannula. There is conflicting data for patients requiring lower-level oxygen support.</p></div><div><h3>Research question</h3><p>Does APP reduce escalation of oxygen support in COVID-19 patients requiring supplementary oxygen?The primary outcome was defined as an escalation of oxygen support from simple supplementary oxygen (NP, HM, NRB) <strong><em>to</em></strong> NIV (CPAP or BiPAP), HFNC or IMV; <strong>OR</strong> from NIV (CPAP or BiPAP) or HFNC <strong><em>to</em></strong> IMV by day30.</p></div><div><h3>Study design</h3><p>Two center, prospective, non-blind, randomised controlled trial. Patients with confirmed or suspected COVID-19 pneumonia requiring ≥ 5 liters/min oxygen to maintain saturations ≥ 94 % were randomised to either APP or control group. The APP group received a 3-h APP session three times per day for three days.</p></div><div><h3>Results</h3><p>Between 9 May and July 13, 2021, 89 adults were screened and 61 enrolled, 31 to awake prone position and 30 controls. There was no difference in the primary outcome, 7 (22.6 %) patients randomised to APP and 9 (30.0 %) controls required escalation of oxygen support (OR 0.68 (0.22–2.14), <em>P</em> = 0.51). There were no differences in any secondary outcomes, in APP did not improve oxygenation.</p></div><div><h3>Interpretation</h3><p>In COVID-19 patients, the use of APP did not prevent escalation of oxygen support from supplementary to invasive or non-invasive ventilation or improve patient respiratory physiology.</p></div><div><h3>Trial registration</h3><p>NCT04853979 (<span>clinicaltrials.gov</span><svg><path></path></svg>).</p></div>\",\"PeriodicalId\":37937,\"journal\":{\"name\":\"Contemporary Clinical Trials Communications\",\"volume\":\"39 \",\"pages\":\"Article 101295\"},\"PeriodicalIF\":1.4000,\"publicationDate\":\"2024-04-13\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S2451865424000425/pdfft?md5=c016f723ae0edaae0344f5e1efa745fb&pid=1-s2.0-S2451865424000425-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Contemporary Clinical Trials Communications\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2451865424000425\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary Clinical Trials Communications","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2451865424000425","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
A randomised clinical trial of awake prone positioning in COVID-19 suspects with acute hypoxemic respiratory failure
Background
Awake prone position (APP) has been reported to improve oxygenation in patients with COVID-19 disease and to reduce the requirement for invasive mechanical ventilation for patients requiring support with high flow nasal cannula. There is conflicting data for patients requiring lower-level oxygen support.
Research question
Does APP reduce escalation of oxygen support in COVID-19 patients requiring supplementary oxygen?The primary outcome was defined as an escalation of oxygen support from simple supplementary oxygen (NP, HM, NRB) to NIV (CPAP or BiPAP), HFNC or IMV; OR from NIV (CPAP or BiPAP) or HFNC to IMV by day30.
Study design
Two center, prospective, non-blind, randomised controlled trial. Patients with confirmed or suspected COVID-19 pneumonia requiring ≥ 5 liters/min oxygen to maintain saturations ≥ 94 % were randomised to either APP or control group. The APP group received a 3-h APP session three times per day for three days.
Results
Between 9 May and July 13, 2021, 89 adults were screened and 61 enrolled, 31 to awake prone position and 30 controls. There was no difference in the primary outcome, 7 (22.6 %) patients randomised to APP and 9 (30.0 %) controls required escalation of oxygen support (OR 0.68 (0.22–2.14), P = 0.51). There were no differences in any secondary outcomes, in APP did not improve oxygenation.
Interpretation
In COVID-19 patients, the use of APP did not prevent escalation of oxygen support from supplementary to invasive or non-invasive ventilation or improve patient respiratory physiology.
期刊介绍：
Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
