{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,13]],"date-time":"2025-12-13T07:43:37Z","timestamp":1765611817571,"version":"3.48.0"},"reference-count":26,"publisher":"BMJ","issue":"7","license":[{"start":{"date-parts":[[2023,7,12]],"date-time":"2023-07-12T00:00:00Z","timestamp":1689120000000},"content-version":"unspecified","delay-in-days":11,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Assistance Publique \u2013 H\u00f4pitaux de Paris","award":["CRC-20012"],"award-info":[{"award-number":["CRC-20012"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2023,6,8]]},"published-print":{"date-parts":[[2023,7]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Delirium is a severe complication that is associated with short-term adverse events, prolonged hospital stay and neurological sequelae in survivors. Automated pupillometry is an easy-to-use device that allows for accurate objective assessment of the pupillary light responses in comatose patients in the intensive care unit (ICU). Whether automated pupillometry might predict delirium in critically ill patients is not known. We hypothesise that automated pupillometry could predict the occurrence of delirium in critically ill patients without primary brain injury, requiring more than 48\u2009hours of invasive mechanical ventilation in the ICU.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>The PupillOmetry for preDIction of DeliriUM in ICU (PODIUM) study is a prospective cohort study, which will be conducted in eight French ICUs in the Paris area. We aim to recruit 213 adult patients requiring invasive mechanical ventilation for more than 48 hours. Automated pupillometry (Neurological Pupil Index; NPi-200, Neuroptics) will be assessed two times per day for 7\u2009days. Delirium will be assessed using the Confusion Assessment Method in ICU two times per day over 14 days in non-comatose patients (Richmond Agitation and Sedation Scale \u2265\u22123).<\/jats:p>\n                    <jats:p>The predictive performances of the seven automated pupillometry parameters (ie, pupillary diameter, variation of the pupillary diameter, pupillary constriction speed, pupillary dilatation speed, photomotor reflex latency, NPi and symmetry of pupillary responses) measured to detect the delirium occurrence within 14 days will be the main outcomes. Secondary outcomes will be the predictive performances of the seven automated pupillometry parameters to detect complications related to delirium, ICU length of stay, mortality, functional and cognitive outcomes at 90 days.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The PODIUM study has been approved by an independent ethics committee, the Comit\u00e9 de Protection des Personnes (CPP) OUEST IV\u2014NANTES (CPP21.02.15.45239 32\/21_3) on 06 April 2021). Participant recruitment started on 15 April 2022. Results will be published in international peer-reviewed medical journals and presented at conferences.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT05248035\">NCT05248035<\/jats:ext-link>\n                      ; clinicaltrials.gov.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2023-072095","type":"journal-article","created":{"date-parts":[[2023,7,12]],"date-time":"2023-07-12T10:38:41Z","timestamp":1689158321000},"page":"e072095","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["PupillOmetry for preDIction of DeliriUM in ICU (PODIUM): protocol for a prospective multicentre cohort study"],"prefix":"10.1136","volume":"13","clinical-trial-number":[{"clinical-trial-number":"nct05248035","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0922-3393","authenticated-orcid":false,"given":"Pierre","family":"Jaquet","sequence":"first","affiliation":[{"name":"Intensive Care Unit, Delafontaine Hospital, Saint Denis, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5006-6249","authenticated-orcid":false,"given":"Camille","family":"Couffignal","sequence":"additional","affiliation":[{"name":"Research Clinic, Epidemiology, Biostatistic Department Bichat hospital, DMU PRISME, Assistance Publique des H\u00f4pitaux de Paris Nord, Groupe Hospitalier Universitaire Paris Cit\u00e9, Paris, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Coralie","family":"Tardivon","sequence":"additional","affiliation":[{"name":"Research Clinic, Epidemiology, Biostatistic Department Bichat hospital, DMU PRISME, Assistance Publique des H\u00f4pitaux de Paris Nord, Groupe Hospitalier Universitaire Paris Cit\u00e9, Paris, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Virginie","family":"Godard","sequence":"additional","affiliation":[{"name":"Research Clinic, Epidemiology, Biostatistic Department Bichat hospital, DMU PRISME, Assistance Publique des H\u00f4pitaux de Paris Nord, Groupe Hospitalier Universitaire Paris Cit\u00e9, Paris, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Romane","family":"Bellot","sequence":"additional","affiliation":[{"name":"Research Clinic, Epidemiology, Biostatistic Department Bichat hospital, DMU PRISME, Assistance Publique des H\u00f4pitaux de Paris Nord, Groupe Hospitalier Universitaire Paris Cit\u00e9, Paris, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Benjamin","family":"Assouline","sequence":"additional","affiliation":[{"name":"Medical Intensive 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France"},{"name":"Medical Intensive Care Unit, D\u00e9partement R3S, Assistance Publique - H\u00f4pitaux de Paris, Sorbonne Universit\u00e9, Piti\u00e9-Salp\u00eatri\u00e8re Hospital, Paris, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Julien","family":"Dessajan","sequence":"additional","affiliation":[{"name":"Medical Intensive Care Unit, Assistance Publique-H\u00f4pitaux de Paris Nord, Bichat Claude Bernard Hospital, Paris, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bertrand","family":"Hermann","sequence":"additional","affiliation":[{"name":"Medical Intensive Care Unit, Assistance Publique - H\u00f4pitaux de Paris Centre, Universit\u00e9 Paris Cit\u00e9, H\u00f4pital Europ\u00e9en Georges Pompidou, Paris, France"},{"name":"INSERM UMR 1266 Institut de Psychiatrie et Neurosciences de Paris (IPNP), Universit\u00e9 de Paris, Paris, \u00cele-de-France, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas","family":"Rambaud","sequence":"additional","affiliation":[{"name":"Medical Intensive Care Unit, Assistance Publique - H\u00f4pitaux de Paris, Avicenne Hospital, Bobigny, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2236-0288","authenticated-orcid":false,"given":"Guillaume","family":"Voiriot","sequence":"additional","affiliation":[{"name":"Medical Intensive Care Unit, Assistance Publique\u2014Hopitaux de Paris, Tenon Hospital, Paris, France"},{"name":"INSERM UMRS938, Sorbonne universit\u00e9, Centre de recherche Saint-Antoine, Paris, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0245-309X","authenticated-orcid":false,"given":"Romain","family":"Sonneville","sequence":"additional","affiliation":[{"name":"Medical Intensive Care Unit, Assistance Publique-H\u00f4pitaux de Paris Nord, Bichat Claude 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