Browsing by Author "Cavalcanti, Alexandre Biasi"

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    Adherence to low tidal volume in the transition to spontaneous ventilation in patients with acute respiratory failure in intensive care units in Latin America (SPIRAL): a study protocol
    (Associacao de Medicina Intensiva Brasileira - AMIB, 2024) Diniz-Silva, Fabia; Pinheiro, Bruno Valle; Reyes, Luis Felipe; Cavalcanti, Alexandre Biasi; Figueredo, Belinda; Rios, Fernando; Machado, Flávia Ribeiro; Preda, Gabriel; Bugedo Tarraza, Guillermo Jaime; Maia, Israel Silva; da Silveira, Leda Tomiko Yamada; Herrera, Luis; Jibaja, Manuel; Ibarra-Estrada, Miguel; Cestari, Mino; Nin, Nicolás; Roldan, Rollin; Dos Santos, Tiago Mendonça; Veiga, Viviane Cordeiro; Bruhn Cruz, Alejandro Rodrigo; Ferreira, Juliana Carvalho
    © 2024, Associacao de Medicina Intensiva Brasileira - AMIB. All rights reserved.Objective: Patients with acute respiratory failure often require mechanical ventilation to reduce the work of breathing and improve gas exchange; however, this may exacerbate lung injury. Protective ventilation strategies, characterized by low tidal volumes (≤ 8mL/kg of predicted body weight) and limited plateau pressure below 30cmH2O, have shown improved outcomes in patients with acute respiratory distress syndrome. However, in the transition to spontaneous ventilation, it can be challenging to maintain tidal volume within protective levels, and it is unclear whether low tidal volumes during spontaneous ventilation impact patient outcomes. We developed a study protocol to estimate the prevalence of low tidal volume ventilation in the first 24 hours of spontaneous ventilation in patients with hypoxemic acute respiratory failure and its association with ventilator-free days and survival. Methods: We designed a multicenter, multinational, cohort study with a 28-day follow-up that will include patients with acute respiratory failure, defined as a partial oxygen pressure/ fraction of inspired oxygen ratio < 300mmHg, in transition to spontaneous ventilation in intensive care units in Latin America. Results: We plan to include 422 patients in ten countries. The primary outcomes are the prevalence of low tidal volume in the first 24 hours of spontaneous ventilation and ventilator-free days on day 28. The secondary outcomes are intensive care unit and hospital mortality, incidence of asynchrony and return to controlled ventilation and sedation. Conclusion: In this study, we will assess the prevalence of low tidal volume during spontaneous ventilation and its association with clinical outcomes, which can inform clinical practice and future clinical trials.
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    Statistical analysis plan for early goal-directed therapy using a physiological holistic view - The andromeda-shock: a randomized controlled trial
    (2018) Hernández P., Glenn; Cavalcanti, Alexandre Biasi; Ospina-Tascón, Gustavo; Dubin, Arnaldo; Hurtado, Francisco Javier; Damiani, Lucas Petri; Friedman, Gilberto; Castro López, Ricardo; Alegría, Leyla; Bakker, Jan; Cecconi, Maurizio; Teboul, Jean-Louis
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    Statistical analysis plan for hemodynamic phenotype-based, capillary refill time-targeted resuscitation in early septic shock: the ANDROMEDA-SHOCK-2 randomized clinical trial
    (Associacao de Medicina Intensiva Brasileira - AMIB, 2025) Orozco, Nicolás; Garcia-Gallardo, Gustavo; Cavalcanti, Alexandre Biasi; Dos Santos, Tiago Mendonça; Ospina-Tascón, Gustavo; Bakker, Jan; Morales Ahumada, Sebastián Alonso; Ramos, Karla; Alegría Vargas, Leyla; Teboul, Jean Louis; De Backer, Daniel; Vieillard-Baron, Antoine; Hernández, Liliana Vallecilla; de Lima, Lucas Martins; Damiani, Lucas Petri; Sady, Erica Ribeiro; Santucci, Eliana Vieira; Hernández P., Glenn; Kattan Tala, Eduardo José
    Background: ANDROMEDA-SHOCK 2 is an international, multicenter, randomized controlled trial comparing hemodynamic phenotype-based, capillary refill time-targeted resuscitation in early septic shock to standard care resuscitation to test the hypothesis that the former is associated with lower morbidity and mortality in terms of hierarchal analysis of outcomes. Objective: To report the statistical plan for the ANDROMEDA--SHOCK 2 randomized clinical trial. Methods: We briefly describe the trial design, patients, methods of randomization, interventions, outcomes, and sample size. We portray our planned statistical analysis for the hierarchical primary outcome using the stratified win ratio method, as well as the planned analysis for the secondary and tertiary outcomes. We also describe the subgroup and sensitivity analyses. Finally, we provide details for presenting our results, including mock tables, baseline characteristics, and the effects of treatments on outcomes. Conclusion: According to best trial practices, we report our statistical analysis plan and data management plan prior to locking the database and initiating the analyses. We anticipate that this practice will prevent analysis bias and improve the utility of the study’s reported results.