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dc.contributor.authorNordberg, Per
dc.contributor.authorTaccone, F.
dc.contributor.authorTruhlar, A.
dc.contributor.authorForsberg, S.
dc.contributor.authorHollenberg, J.
dc.contributor.authorJonsson, M.
dc.contributor.authorCuny, J.
dc.contributor.authorGoldstein, P.
dc.contributor.authorVermeersch, N
dc.contributor.authorHiguet, A
dc.contributor.authorJimenes, F.
dc.contributor.authorOrtiz, F.
dc.contributor.authorWilliams, Julia
dc.contributor.authorDesruelles, D
dc.contributor.authorCreteur, J
dc.contributor.authorDillenback, E.
dc.contributor.authorBusche, C
dc.contributor.authorBusch, Hans-Jorg
dc.contributor.authorRingh, M.
dc.contributor.authorKonrad, D.
dc.contributor.authorPeterson, J
dc.contributor.authorVincent, Jean-Louis
dc.contributor.authorSvensson, Leif
dc.date.accessioned2019-07-31T16:21:53Z
dc.date.available2019-07-31T16:21:53Z
dc.date.issued2019-05-07
dc.identifier.citationNordberg , P , Taccone , F , Truhlar , A , Forsberg , S , Hollenberg , J , Jonsson , M , Cuny , J , Goldstein , P , Vermeersch , N , Higuet , A , Jimenes , F , Ortiz , F , Williams , J , Desruelles , D , Creteur , J , Dillenback , E , Busche , C , Busch , H-J , Ringh , M , Konrad , D , Peterson , J , Vincent , J-L & Svensson , L 2019 , ' Effect of Trans-Nasal Evaporative Intra-arrest Cooling on Functional Neurologic Outcome in Out-of-Hospital Cardiac Arrest : The PRINCESS Randomized Clinical Trial ' , JAMA - Journal of the American Medical Association , vol. 321 , no. 17 , pp. 1677 - 1685 . https://doi.org/10.1001/jama.2019.4149
dc.identifier.issn0098-7484
dc.identifier.otherPURE: 16339044
dc.identifier.otherPURE UUID: c9c940e3-977c-4c3a-abd0-4f7fb2b2593d
dc.identifier.otherScopus: 85065779601
dc.identifier.otherORCID: /0000-0003-0796-5465/work/62748017
dc.identifier.urihttp://hdl.handle.net/2299/21510
dc.description© 2019 American Medical Association. All rights reserved.
dc.description.abstractImportance: Therapeutic hypothermia may increase survival with good neurologic outcome after cardiac arrest. Trans-nasal evaporative cooling is a method used to induce cooling, primarily of the brain, during cardiopulmonary resuscitation (ie, intra-arrest). Objective: To determine whether prehospital trans-nasal evaporative intra-arrest cooling improves survival with good neurologic outcome compared with cooling initiated after hospital arrival. Design, Setting, and Participants: The PRINCESS trial was an investigator-initiated, randomized, clinical, international multicenter study with blinded assessment of the outcome, performed by emergency medical services in 7 European countries from July 2010 to January 2018, with final follow-up on April 29, 2018. In total, 677 patients with bystander-witnessed out-of-hospital cardiac arrest were enrolled. Interventions: Patients were randomly assigned to receive trans-nasal evaporative intra-arrest cooling (n = 343) or standard care (n = 334). Patients admitted to the hospital in both groups received systemic therapeutic hypothermia at 32°C to 34°C for 24 hours. Main Outcomes and Measures: The primary outcome was survival with good neurologic outcome, defined as Cerebral Performance Category (CPC) 1-2, at 90 days. Secondary outcomes were survival at 90 days and time to reach core body temperature less than 34°C. Results: Among the 677 randomized patients (median age, 65 years; 172 [25%] women), 671 completed the trial. Median time to core temperature less than 34°C was 105 minutes in the intervention group vs 182 minutes in the control group (P < .001). The number of patients with CPC 1-2 at 90 days was 56 of 337 (16.6%) in the intervention cooling group vs 45 of 334 (13.5%) in the control group (difference, 3.1% [95% CI, -2.3% to 8.5%]; relative risk [RR], 1.23 [95% CI, 0.86-1.72]; P = .25). In the intervention group, 60 of 337 patients (17.8%) were alive at 90 days vs 52 of 334 (15.6%) in the control group (difference, 2.2% [95% CI, -3.4% to 7.9%]; RR, 1.14 [95% CI, 0.81-1.57]; P = .44). Minor nosebleed was the most common device-related adverse event, reported in 45 of 337 patients (13%) in the intervention group. The adverse event rate within 7 days was similar between groups. Conclusions and Relevance: Among patients with out-of-hospital cardiac arrest, trans-nasal evaporative intra-arrest cooling compared with usual care did not result in a statistically significant improvement in survival with good neurologic outcome at 90 days. Trial Registration: ClinicalTrials.gov Identifier: NCT01400373.en
dc.format.extent9
dc.language.isoeng
dc.relation.ispartofJAMA - Journal of the American Medical Association
dc.subjectAged
dc.subjectBrain/physiopathology
dc.subjectBrain Injuries/etiology
dc.subjectCardiopulmonary Resuscitation/methods
dc.subjectEmergency Medical Services
dc.subjectEpistaxis/etiology
dc.subjectFemale
dc.subjectHumans
dc.subjectHypothermia, Induced/adverse effects
dc.subjectMale
dc.subjectMiddle Aged
dc.subjectOut-of-Hospital Cardiac Arrest/complications
dc.subjectSample Size
dc.subjectSingle-Blind Method
dc.subjectSurvival Rate
dc.subjectTime-to-Treatment
dc.subjectTreatment Outcome
dc.titleEffect of Trans-Nasal Evaporative Intra-arrest Cooling on Functional Neurologic Outcome in Out-of-Hospital Cardiac Arrest : The PRINCESS Randomized Clinical Trialen
dc.contributor.institutionSchool of Health and Social Work
dc.contributor.institutionAllied Health Professions
dc.contributor.institutionParamedic Science
dc.description.statusPeer reviewed
dc.date.embargoedUntil2019-11-07
dc.identifier.urlhttp://www.scopus.com/inward/record.url?scp=85065779601&partnerID=8YFLogxK
rioxxterms.versionAM
rioxxterms.versionofrecordhttps://doi.org/10.1001/jama.2019.4149
rioxxterms.typeJournal Article/Review


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