bca9a4fa70faa3c2059fb365c8370159 13063_2024_Article_8140.pdf 1787bf2e8c38978fa9908cc652d57d98bf66ef97 13063_2024_Article_8140.pdf 4de648e94e44e527aadca71d0392201dd7bf82e310081f0234bb96dc0b63f477 13063_2024_Article_8140.pdf Title: Personalized mechanical ventilation guided by ultrasound in patients with acute respiratory distress syndrome (PEGASUS): study protocol for an international randomized clinical trial Subject: Trials, https://doi.org/10.1186/s13063-024-08140-7 Keywords: Acute respiratory distress syndrome;Personalized medicine;Mechanical ventilation;Lung ultrasound Author: Jante S. Sinnige Creator: Adobe InDesign 15.1 (Windows) Producer: Adobe PDF Library 15.0; modified using iText® 5.3.5 ©2000-2012 1T3XT BVBA (SPRINGER SBM; licensed version) CreationDate: Tue May 7 12:28:50 2024 CEST ModDate: Tue May 7 20:19:06 2024 CEST Custom Metadata: yes Metadata Stream: yes Tagged: no UserProperties: no Suspects: no Form: none JavaScript: no Pages: 14 Encrypted: no Page size: 595.276 x 790.866 pts Page rot: 0 File size: 1113472 bytes Optimized: no PDF version: 1.4 name type encoding emb sub uni object ID ------------------------------------ ----------------- ---------------- --- --- --- --------- MyriadPro-Regular Type 1C Custom yes no yes 36 0 MyriadPro-Bold Type 1C Custom yes no yes 39 0 MyriadPro-It Type 1C Custom yes no yes 38 0 MOEJAT+MyriadPro-Regular2 Type 1C WinAnsi yes yes no 298 0 MyriadPro-Light Type 1C Custom yes no yes 37 0 MyriadPro-Semibold Type 1C Custom yes no yes 40 0 WarnockPro-Regular Type 1C Custom yes no yes 41 0 MyriadPro-Regular3 Type 1C WinAnsi yes no yes 245 0 IDDYTX+STIX-Regular Type 1C Custom yes yes yes 95 0 TBTDNQ+MyriadPro-LightIt Type 1C WinAnsi yes yes yes 107 0 CFLXMF+WarnockPro-It Type 1C Custom yes yes yes 140 0 Jhove (Rel. 1.28.0, 2023-05-18) Date: 2026-03-20 05:03:41 CET RepresentationInformation: 13063_2024_Article_8140.pdf ReportingModule: PDF-hul, Rel. 1.12.4 (2023-03-16) LastModified: 2026-03-19 16:28:41 CET Size: 1113472 Format: PDF Version: 1.4 Status: Well-Formed and valid SignatureMatches: PDF-hul MIMEtype: application/pdf PDFMetadata: Objects: 446 FreeObjects: 1 IncrementalUpdates: 0 DocumentCatalog: ViewerPreferences: HideToolbar: false HideMenubar: false HideWindowUI: false FitWindow: false CenterWindow: false DisplayDocTitle: false NonFullScreenPageMode: UseNone Direction: L2R ViewArea: CropBox ViewClip: CropBox PrintArea: CropBox PageClip: CropBox PageLayout: SinglePage PageMode: UseOutlines Language: en-US Outlines: Item: Title: Personalized mechanical ventilation guided by ultrasound in patients with acute respiratory distress syndrome (PEGASUS): study protocol for an international randomized clinical trial Children: Item: Title: Abstract Children: Item: Title: Background Item: Title: Methods Item: Title: Discussion Item: Title: Trial registration Item: Title: Administrative information Item: Title: Introduction Children: Item: Title: Background and rationale {6a} Item: Title: Objectives {7} Item: Title: Trial design {8} Item: Title: Methods: participants, interventions and outcomes Children: Item: Title: Study setting {9} Item: Title: Eligibility criteria {10} Item: Title: Who will take informed consent? {26a} Item: Title: Additional consent provisions for collection and use of participant data and biological specimens {26b} Item: Title: Interventions Children: Item: Title: Explanation for the choice of comparators {6b} Item: Title: Intervention description {11a} Item: Title: Criteria for discontinuing or modifying allocated interventions {11b} Item: Title: Strategies to improve adherence to interventions {11c} Item: Title: Relevant concomitant care permitted or prohibited during the trial {11d} Item: Title: Provisions for post-trial care {30} Item: Title: Outcomes {12} Item: Title: Participant timeline {13} Item: Title: Sample size {14} Item: Title: Recruitment {15} Item: Title: Assignment of interventions: allocation Children: Item: Title: Sequence generation {16a} Item: Title: Concealment mechanism {16b} Item: Title: Implementation {16c} Item: Title: Assignment of interventions: blinding Children: Item: Title: Who will be blinded {17a} Item: Title: Procedure for unblinding if needed {17b} Item: Title: Data collection and management Children: Item: Title: Plans for assessment and collection of outcomes {18a} Item: Title: Plans to promote participant retention and complete follow-up {18b} Item: Title: Data management {19} Item: Title: Confidentiality {27} Item: Title: Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular analysis in this trialfuture use {33} Item: Title: Statistical methods Children: Item: Title: Statistical methods for primary and secondary outcomes {20a} Item: Title: Interim analyses {21b} Item: Title: Methods for additional analyses (e.g., subgroup analyses) {20b} Item: Title: Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c} Item: Title: Plans to give access to the full protocol, participant-level data, and statistical code {31c} Item: Title: Oversight and monitoring Children: Item: Title: Composition of the coordinating center and trial steering committee {5d} Item: Title: Composition of the data monitoring committee, its role and reporting structure {21a} Item: Title: Adverse event reporting and harms {22} Item: Title: Frequency and plans for auditing trial conduct {23} Item: Title: Plans for communicating important protocol amendments to relevant parties (e.g., trial participants, ethical committees) {25} Item: Title: Dissemination plans {31a} Item: Title: Discussion Item: Title: Trial status Item: Title: Acknowledgements Item: Title: References Info: Title: Personalized mechanical ventilation guided by ultrasound in patients with acute respiratory distress syndrome (PEGASUS): study protocol for an international randomized clinical trial Author: Jante S. 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Sinnige Marry R. Smit Aniruddha Ghose Harm-Jan de Grooth Theis Skovsgaard Itenov Eleni Ischaki John Laffey Frederique Paulus Pedro Póvoa Charalampos Pierrakos Luigi Pisani Oriol Roca Marcus J. Schultz Konstanty Szuldrzynski Pieter R. Tuinman Claudio Zimatore Lieuwe D. J. Bos A. K. M. Arif Uddin Ahmed Mohammad Jhahidul Alam Mohsammad Rafiqual Alam Anjan Bal Samarjit Barua Rajdeep Biswas Mohammed Abdur Rahaman Chowdhury Safiqul Mostafa Chy Satyajit Dhar Pranay Kumar Dutta Syeda Nafisa Khatoon Ranjan Kumar Nath Nahid Nowroz Mithun Shil Rachid Attou Leonel Barreto Gutierrez Keitiane Kaefer Morten Bestle Lars Hein Thomas Hildebrandt Jacob Jensen Sanne Lauritzen Ulf Pedersen Lone Poulsen Harry Giannopoulos Katerina Vaporidi Lauren Ferguson Yvelynne Kelly Sabina Mason Aisling McMahon Bairbre McNicholas Daniele Biasucci Gianmaria Cammarota Maurizio Follino Salvatore Grasso Antonio Latela Giovanna Magnesa Fabrizia Massaro Leonarda Maurmo Marco Pezzuto Savino Spadaro Luigi Vetrugno Massimo Zambon Daan Filippini Peter Klompmaker Amne Mousa Dominik Daszuta Miłosz Jankowski Irene Aragao Heloisa Castro Vasco Costa Cristina Torrão Toni Antoni Marta Arroyo Marta Briva Nuria Duran Marina García-de-Acilu Gemma Goma Ana Ochagavia Michelle Chew Mariangela Pellegrini Gaetano Perchiazzi 10.1186/s13063-024-08140-7 2010-04-23 true springer.com springerlink.com https://doi.org/10.1186/s13063-024-08140-7 10.1186/s13063-024-08140-7 1745-6215 journal Trials The Author(s) 2010-04-23 true 10.1186/s13063-024-08140-7 noindex springer.com springerlink.com uuid:83ce60a5-6462-44cf-8e9b-e43fd8fc060d uuid:cd9ddee2-3a2b-47d6-b03c-14bf2371bd92 default 1 converted uuid:83ce60a5-6462-44cf-8e9b-e43fd8fc060d converted to PDF/A-2b pdfToolbox 2024-05-07T10:35:20Z 2 B Jante S. 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