ࡱ>  Nbjbj77 ]k]k 844ZCC"eeeh"eelȃjeefnpue i]^OqDރ0qXuuv [| U: Version numberDocument DateSubmission DateREC Approval DateMain reason for changeSummary of changes made5.016/09/202517/11/202517/12/2025Substantial Amendment to implement changes which were approved in the variation to contract18-month extension of study duration Update to trial flow diagram, recruitment graph and trial timetable Clarification of definition of adherence Changes to sample size and power calculation Update to statistical analysis methodology Additional health economic analysis META analysis with US HART trial Update to National Data Opt Out data collection Update to appendix A to clarify Finnish consent and data collection process Inclusion of easy read patient information sheet: AIRWAYS3_EasyRead_PIS_v1.0 171120254.119/06/202515/07/2025N/ANon-substantial change to clarify NDOO data collectionClarification of national data opt-out data collection Change of address for Sponsor R&D Department4.021/08/202403/12/202403/12/2024Clarity in data collection timelines, administrative change of details and addition of international siteClarification of data collection timelines Change of Trial Manager details Addition of the Republic of Ireland as an international site as detailed in Appendix B 3.015/12/202318/12/202318/01/2024Addition of international sites and clarity in exclusion criteria Updated the eligibility criteria to provide additional clarity around patients who have a cardiac arrest in the Emergency Department, to amend Patients in the emergency department to Patients who have a cardiac arrest outside hospital and who are transported to the hospital in ongoing cardiac arrest Addition of international recruitment which is supported by University of TV acting as co-sponsor Addition of details around international recruitment commencing with Finland.2.017/11/202223/11/202209/12/2022Clarity in inclusion criteria regarding randomising clinician.Clarity in inclusion criteria regarding randomising clinician. Change to the exclusion criteria to include patients who are currently receiving airways management via a supraglottic airways device as this is standard care in many hospitals. 1.109/05/2022      AIRWAYS-3 Protocol Version Log PAGE  (Current versions in use highlighted in green) Page  PAGE \* MERGEFORMAT 2 AIRWAYS-3 Version Log V1.5 19/02/2026 -?Vnorstu}~ Y  O ɷwb)hQ"shwB*CJOJQJ^JaJph1hU9hU9B*CJOJQJ^JaJmH phsH )hwhwB*CJOJQJ^JaJph#hwB*CJOJQJ^JaJph#hU9B*CJOJQJ^JaJphhwCJOJQJ^JaJ#hhp5CJOJQJ^JaJ,hX_hp5B*CJOJQJ^JaJph -?Vnos~ Y  O  & F$ &P#$/IfgdQ"s & F$ &P#$/IfgdwFfj$$ &P#$/Ifa$gd5i)   G ~ ; g ѼnYYYD5hheCJOJQJ^J)h/heB*CJOJQJ^JaJph)heheB*CJOJQJ^JaJph#heB*CJOJQJ^JaJphheCJOJQJ^JaJhhQ"sCJOJQJ^J)hehQ"sB*CJOJQJ^JaJphhQ"sOJQJ^J)hQ"shQ"sB*CJOJQJ^JaJph#hQ"sB*CJOJQJ^JaJphhQ"sCJOJQJ^JaJhhwCJOJQJ^J   G ~ ; g Ff  & F$ &P#$/IfgdeFfu & F$ &P#$/IfgdQ"s$$ &P#$/Ifa$gd5i)Ff  I yz/034>?IJTU˹yyyygUggMggMh^CJaJ#hX_h9ECJOJQJ\^JaJ#h^B*CJOJQJ^JaJphh9ECJOJQJ^JaJh^CJOJQJ^JaJhh/CJOJQJ^J)heh/B*CJOJQJ^JaJph#heB*CJOJQJ^JaJph)h/h/B*CJOJQJ^JaJph#h/B*CJOJQJ^JaJphh/CJOJQJ^JaJ  I z/04?JUuLkd$IfK$L$l4F t44 l4Bayt^$ &P#$/Ifgd5i)K$Ff} & F$ &P#$/Ifgd/$$ &P#$/Ifa$gd5i) wr_____$$ &P#$/Ifa$gd5i)Ff d$ &P#$/If^gd5i)\kd#$IfK$L$l40Fg t44 l4Bayt^$ &P#$/Ifgd5i)K$ ñ{soosoooosoosooooaXhcY5OJQJjh^UmHnHuhKjhKU hhCJOJQJ^JaJ hhpCJOJQJ^JaJ&hX_hp5CJOJQJ\^JaJ#hX_hpCJOJQJ\^JaJ h17hpCJOJQJ^JaJh^CJOJQJ^JaJhh9ECJOJQJ^JhX_h9ECJOJQJ^Jvw  9r  =ABgd30  9r N9=ABgdgd^ gdFfx$ &P#$/If^gd5i)tuvwx~ĿЮ|pdXPhcYOJQJh$]#CJOJQJaJh/CJOJQJaJhw!CJOJQJaJhhcYCJOJQJaJhhcYCJOJQJaJ hcY0JjhcY0JUhcY h!7hcY5B*OJQJphP hcY5h],hcY5OJQJh\+hcY5h\+hcY5OJQJh5OJQJhcY5OJQJh^5OJQJwJKLMN gdh]hgdU?J &`#$gdU?J$-:;=>?ABDHIJKLMNȰȰ hhCJOJQJ^JaJh{QhcYhs]hcYOJQJh/OJQJhU9OJQJh, OJQJhlOJQJh^OJQJhcYOJQJh, OJQJmHnHuhhcYOJQJjhhcYOJQJUF0P1h0/R :pFFA .!"#$% DpF_\ ђUTpJFIF``C     C   " }!1AQa"q2#BR$3br %&'()*456789:CDEFGHIJSTUVWXYZcdefghijstuvwxyz w!1AQaq"2B #3Rbr $4%&'()*56789:CDEFGHIJSTUVWXYZcdefghijstuvwxyz ?S(((((((((((hyeu$RpI'ҼGFNoe^rKu_~ڵJU]aZho\<^Pۑۢڼk_K-ɤ۞j|{?LWO&5SQů/n.ig'5HFVRCGQZ_p0/Vǽ ?E2k1$M#f%Sm!x+ԼG#Pǻ'UWVYC$ UԥFE*_ϸRY;YFRX J_x& HOf[G?v;$⾮l ![i4QErEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPEPMfXԳ% uxƯ;{^̇!~^Mԗ*2QR39?EĚ^!M6: cƺ&: V%s^TiG9)NQDŽu?j"Ma̒=Xf? ױ2\(1e:~'']5a=.+ :+7nǹ?jկ2&S:#ء=e#Pt(32|A}+VU

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