{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T14:29:56Z","timestamp":1790864996925,"version":"4.1.0"},"reference-count":48,"publisher":"BMJ","issue":"6","funder":[{"DOI":"10.13039\/501100014630","name":"Minist\u00e8re des Solidarit\u00e9s et de la Sant\u00e9","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100014630","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"published-print":{"date-parts":[[2018,6]]},"abstract":"<jats:sec><jats:title>Introduction<\/jats:title><jats:p>Elderly patients constitute an increasingly large proportion of the high-risk surgical group. In adult patients, several specific intraoperative approaches such as cardiac output-guided haemodynamic therapy, depth of anaesthesia monitoring (DAM) or lung-protective ventilation (LPV) are designed to reduce postoperative mortality and surgical complications. However, none of these approaches has been specifically performed in the elderly, and no evaluation of a multimodal optimisation strategy for general anaesthesia has been achieved in this population.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aims<\/jats:title><jats:p>The objective of this study is to assess, in high-risk patients aged 75 years and over undergoing high-risk surgery, the effectiveness of combined optimisation of anaesthesia involving goal-directed haemodynamic therapy (GDHT), LPV and electroencephalographic DAM on postoperative morbidity and mortality. The primary outcome of the study is a composite criterion associating major postoperative complications and mortality occurring within the 30 first postoperative days. The secondary outcomes are 1-year postoperative autonomy and mortality.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods and analysis<\/jats:title><jats:p>This prospective, randomised, controlled, multicentre trial using a stepped wedge cluster design will be conducted in 27 French university centres. Patients aged 75 years and over, undergoing femoral head fractures and major intraperitoneal or vascular elective surgeries will be included after informed consent. They will benefit from usual care in the \u2018control group\u2019 and from a combined optimisation of general anaesthesia involving GDHT, LPV and DAM in the \u2018optimisation group\u2019. The cluster\u2019s crossover will be unidirectional, from control to optimisation, and randomised. Data will be recorded at inclusion, the day of surgery, 7\u2009days, 30\u2009days and 1year postoperatively and collected into a hosted electronic case report form. The primary outcome of the study is a composite criterion associating major postoperative complications and mortality occurring within the 30 first postoperative days. The secondary outcomes are 1- year postoperative autonomy and mortality.<\/jats:p><\/jats:sec><jats:sec><jats:title>Ethics and dissemination<\/jats:title><jats:p>This protocol was approved by the ethics committee Sud-Est 1 and the French regulatory agency. The finding of the trial will be disseminated through peer-reviewed journals and conferences<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration number<\/jats:title><jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"NCT02668250\" ext-link-type=\"clintrialgov\" specific-use=\"clinicaltrial pre-results\">NCT02668250<\/jats:ext-link><\/jats:p><\/jats:sec>","DOI":"10.1136\/bmjopen-2017-021053","type":"journal-article","created":{"date-parts":[[2023,4,5]],"date-time":"2023-04-05T17:48:26Z","timestamp":1680716906000},"page":"e021053","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":5,"title":["Stepped wedge cluster randomised controlled trial to assess the effectiveness of an optimisation strategy for general anaesthesia on postoperative morbidity and mortality in elderly patients (the OPTI-AGED study): a study protocol"],"prefix":"10.1136","volume":"8","clinical-trial-number":[{"clinical-trial-number":"nct02668250","registry":"10.18810\/clinical-trials-gov","type":"preResults"},{"clinical-trial-number":"nct02668250","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Serge","family":"Molliex","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sylvie","family":"Passot","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emmanuel","family":"Futier","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marl\u00e8ne","family":"Bonnefoi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Florence","family":"Rancon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yannick","family":"Lemanach","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruno","family":"Pereira","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2018,6,19]]},"reference":[{"key":"2023040221245810000_8.6.e021053.1","doi-asserted-by":"publisher","DOI":"10.1097\/00000658-200308000-00003"},{"key":"2023040221245810000_8.6.e021053.2","unstructured":"National Confidential Enquiring into Patient Outcome and Death. Knowing the risk. A review of the peri-operative care of surgical patients. 2011 http:\/\/www.ncepod.org.uk\/2011report2\/downloads\/POC_fullreport.pdf"},{"key":"2023040221245810000_8.6.e021053.3","doi-asserted-by":"publisher","DOI":"10.1016\/S0039-6060(05)80079-0"},{"key":"2023040221245810000_8.6.e021053.4","doi-asserted-by":"publisher","DOI":"10.1001\/archinte.162.18.2053"},{"key":"2023040221245810000_8.6.e021053.5","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-144-8-200604180-00009"},{"key":"2023040221245810000_8.6.e021053.6","doi-asserted-by":"publisher","DOI":"10.1016\/S8756-3282(03)00061-9"},{"key":"2023040221245810000_8.6.e021053.7","doi-asserted-by":"publisher","DOI":"10.1213\/ANE.0b013e3182055384"},{"key":"2023040221245810000_8.6.e021053.8","doi-asserted-by":"publisher","DOI":"10.1213\/ANE.0b013e3181eeaae5"},{"key":"2023040221245810000_8.6.e021053.9","unstructured":"National Institute for Health and Clinical Excellence. NICE diagnostics guidance. Depth of anaesthesia monitors \u2013 Bispectral Index (BIS), E-Entropy and Narcotrend-Compact M. 2012 www.nice.org.uk\/dg6"},{"key":"2023040221245810000_8.6.e021053.10","unstructured":"NHS, Technology Adoption Centre. Intraoperative fluid management technologies, adoption pack. 2013 http:\/\/webarchive.nationalarchives.gov.uk\/20130701143131\/http:\/ntac.nhs.uk\/web\/files\/intra_opertve_fluid_management\/iofm_adoption_pack_update_jan_2013.pdf"},{"key":"2023040221245810000_8.6.e021053.11","doi-asserted-by":"publisher","DOI":"10.1016\/j.annfar.2013.09.010"},{"key":"2023040221245810000_8.6.e021053.12","doi-asserted-by":"publisher","DOI":"10.1093\/bja\/aet466"},{"key":"2023040221245810000_8.6.e021053.13","doi-asserted-by":"publisher","DOI":"10.1093\/bja\/aer273"},{"key":"2023040221245810000_8.6.e021053.14","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2014.5305"},{"key":"2023040221245810000_8.6.e021053.15","doi-asserted-by":"publisher","DOI":"10.1213\/ANE.0000000000000367"},{"key":"2023040221245810000_8.6.e021053.16","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1301082"},{"key":"2023040221245810000_8.6.e021053.17","doi-asserted-by":"publisher","DOI":"10.1097\/ALN.0b013e3181d5e0a3"},{"key":"2023040221245810000_8.6.e021053.18","doi-asserted-by":"publisher","DOI":"10.1097\/ALN.0b013e31820c2b57"},{"key":"2023040221245810000_8.6.e021053.19","doi-asserted-by":"crossref","first-page":"18","DOI":"10.1097\/ALN.0000000000000281","article-title":"Cumulative duration of \"triple low\" state of low blood pressure, low bispectral index, and low minimum alveolar concentration of volatile anesthesia is not associated with increased mortality","volume":"121","author":"Kertai","year":"2014","journal-title":"Anesthesiology"},{"key":"2023040221245810000_8.6.e021053.20","doi-asserted-by":"publisher","DOI":"10.1213\/ANE.0b013e3181c3bfb2"},{"key":"2023040221245810000_8.6.e021053.21","doi-asserted-by":"publisher","DOI":"10.1213\/ane.0b013e31818f603c"},{"key":"2023040221245810000_8.6.e021053.22","doi-asserted-by":"publisher","DOI":"10.1213\/01.ANE.0000147519.82841.5E"},{"key":"2023040221245810000_8.6.e021053.23","doi-asserted-by":"publisher","DOI":"10.1097\/ALN.0b013e31825683dc"},{"key":"2023040221245810000_8.6.e021053.24","doi-asserted-by":"publisher","DOI":"10.1093\/bja\/aeu105"},{"key":"2023040221245810000_8.6.e021053.25","doi-asserted-by":"publisher","DOI":"10.1097\/ANA.0b013e3182712fba"},{"key":"2023040221245810000_8.6.e021053.26","doi-asserted-by":"publisher","DOI":"10.1093\/bja\/aet055"},{"key":"2023040221245810000_8.6.e021053.27","doi-asserted-by":"publisher","DOI":"10.4065\/mcp.2009.0469"},{"key":"2023040221245810000_8.6.e021053.28","doi-asserted-by":"publisher","DOI":"10.1213\/ANE.0000000000000797"},{"key":"2023040221245810000_8.6.e021053.29","unstructured":"WMA Declaration of Helsinki. Ethical principles for medical research: Involving Human Subjects, 1996."},{"key":"2023040221245810000_8.6.e021053.30","doi-asserted-by":"crossref","first-page":"634","DOI":"10.1016\/j.annfar.2009.05.006","article-title":"Optimisation de la prise en charge anesth\u00e9sique en chirurgie abdominale urgente chez le sujet \u00e2g\u00e9","volume":"28","author":"Varvat","year":"2009","journal-title":"Ann Fr Anesth Reanim"},{"key":"2023040221245810000_8.6.e021053.31","doi-asserted-by":"publisher","DOI":"10.1097\/CCM.0b013e318186b9ce"},{"key":"2023040221245810000_8.6.e021053.32","doi-asserted-by":"publisher","DOI":"10.1038\/kisup.2012.1"},{"key":"2023040221245810000_8.6.e021053.33","doi-asserted-by":"publisher","DOI":"10.1161\/CIR.0b013e31826e1058"},{"key":"2023040221245810000_8.6.e021053.34","doi-asserted-by":"publisher","DOI":"10.1093\/eurjhf\/hfs105"},{"key":"2023040221245810000_8.6.e021053.35","doi-asserted-by":"publisher","DOI":"10.1161\/STR.0b013e318284056a"},{"key":"2023040221245810000_8.6.e021053.36","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2016.0287"},{"key":"2023040221245810000_8.6.e021053.37","doi-asserted-by":"publisher","DOI":"10.1007\/s00134-012-2682-1"},{"key":"2023040221245810000_8.6.e021053.38","doi-asserted-by":"publisher","DOI":"10.1378\/chest.128.4.2688"},{"key":"2023040221245810000_8.6.e021053.39","doi-asserted-by":"publisher","DOI":"10.1001\/jama.286.21.2703"},{"key":"2023040221245810000_8.6.e021053.40","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-113-12-941"},{"key":"2023040221245810000_8.6.e021053.41","doi-asserted-by":"publisher","DOI":"10.1016\/S0196-6553(99)70088-X"},{"key":"2023040221245810000_8.6.e021053.42","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2648.2007.04474.x"},{"key":"2023040221245810000_8.6.e021053.43","doi-asserted-by":"publisher","DOI":"10.1097\/01.sla.0000133083.54934.ae"},{"key":"2023040221245810000_8.6.e021053.44","doi-asserted-by":"publisher","DOI":"10.1093\/geront\/10.1_Part_1.20"},{"key":"2023040221245810000_8.6.e021053.45","doi-asserted-by":"publisher","DOI":"10.1093\/geront\/9.3_Part_1.179"},{"key":"2023040221245810000_8.6.e021053.46","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2012.5502"},{"key":"2023040221245810000_8.6.e021053.47","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2010.12.003"},{"key":"2023040221245810000_8.6.e021053.48","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2003.12.013"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2017-021053","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,4,5]],"date-time":"2023-04-05T17:48:42Z","timestamp":1680716922000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2017-021053"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,6]]},"references-count":48,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2018,6,19]]},"published-print":{"date-parts":[[2018,6]]}},"alternative-id":["10.1136\/bmjopen-2017-021053"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2017-021053","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,6]]}}}