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2023-05-18) Date: 2025-02-20 02:43:33 CET RepresentationInformation: 308061.pdf ReportingModule: PDF-hul, Rel. 1.12.4 (2023-03-16) LastModified: 2025-02-19 09:10:22 CET Size: 1202992 Format: PDF Version: 1.4 Status: Well-Formed and valid SignatureMatches: PDF-hul MIMEtype: application/pdf PDFMetadata: Objects: 461 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: Effect of lung volume preservation during spontaneous breathing trial on successful extubation in patients receiving mechanical ventilation: protocol for a multicenter clinical trial Children: Item: Title: Abstract Children: Item: Title: Background Item: Title: Methods Item: Title: Discussion Item: Title: Trial registration 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 obtain 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 of the choice of comparators {6b} Item: Title: Description of the intervention {11a} Children: Item: Title: SBT procedure Item: Title: Extubation procedure Item: Title: Follow-up after extubation Item: Title: Ultrasound monitoring 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} Children: 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: Analytical methods to handle non-adherence to protocol and 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: Effect of lung volume preservation during spontaneous breathing trial on successful extubation in patients receiving mechanical ventilation: protocol for a multicenter clinical trial Author: Carles Subirà Subject: Trials, https://doi.org/10.1186/s13063-024-08297-1 Keywords: Mechanical ventilation;Weaning;Spontaneous breathing trial;Extubation;Lung ultrasound 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: Fri Jul 12 14:48:15 CEST 2024 ModDate: Tue Jul 16 12:44:10 CEST 2024 ID: 0x9631d79d5e457e9cb7e34240b81c6922, 0x3b77037bac74dca73713dc01e7f0ee4c Filters: FilterPipeline: FlateDecode Images: Image: NisoImageMetadata: FormatName: image/png ImageWidth: 115 ImageHeight: 119 BitsPerSample: 8 BitsPerSampleUnit: integer Filter: FlateDecode Intent: RelativeColorimetric Decode: 0, 255 Name: X Image: 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