Comparison of an Early and Intensive Mobilization Protocol Versus Standard Care in Critically Ill Patients Undergoing Invasive Mechanical Ventilation: A Multicenter Clinical Trial.

• Grant number: 24/22927-3
• Support Opportunities: Scholarships in Brazil - Post-Doctoral
• Start date: April 01, 2025
• End date: March 31, 2027
• Field of knowledge: Health Sciences - Physiotherapy and Occupational Therapy
• Principal Investigator: Ada Clarice Gastaldi
• Grantee: Thaís Marina Pires de Campos Biazon
• Host Institution: Faculdade de Medicina de Ribeirão Preto (FMRP). Universidade de São Paulo (USP). Ribeirão Preto , SP, Brazil
• Associated research grant: 22/07841-0 - Rehabilitation of patients submitted to mechanical ventilation, from the ICU to the post-hospital phase: blinded randomized controlled clinical trial, with economic and multicenter evaluation, AP.TEM

Abstract

Introduction: Advances in medical knowledge have contributed to an increase in the number of patients surviving prolonged stays in Intensive Care Units (ICUs). Among these are critically ill patients who develop Acute Respiratory Failure (ARF) and require mechanical ventilation (MV). These individuals experience restricted mobility, often confined to their beds, and may develop pulmonary and systemic complications such as ICU-Acquired Weakness (ICU-AW), which increases the likelihood of reduced functional capacity or death. Early mobilization in the ICU has shown benefits such as improved functional outcomes and reduced length of stay, although evidence remains limited. Furthermore, the type and intensity of exercise still need clearer definition. Previous protocols have lacked continuous follow-up from the ICU to the ward and subsequent outpatient rehabilitation, which has been considered a limitation in some studies. Objectives: The first aim is to compare an intensive early mobilization protocol with standard care in critically ill patients undergoing invasive mechanical ventilation (Project 1). The second aim is to design an intensive mobilization care plan for patients on prolonged mechanical ventilation, encompassing the ICU phase through to post-hospital rehabilitation (Project 2). Methods: This study is a blinded, randomized controlled trial that will be conducted in the ICUs of hospitals affiliated with the Ribeirão Preto Medical School of the University of São Paulo (HCFMRP and UE-HCFMRP), the Federal University of Santa Catarina (UFSC), the University of Gurupi (UnirG), and Universidad del Valle (Colombia). Patients of both genders, aged 21 years or older, and under invasive mechanical ventilation for at least 24 hours will be recruited. Participants will be allocated into two groups: the Intervention Group (IG), which will follow an intensive hospital mobilization protocol, and the Control Group (CG), which will receive usual care limited to 10 minutes of mobilization per day. After discharge to the ward, participants will continue follow-up according to their respective groups.Based on the sample size calculation, a minimum of 26 individuals per group is required to facilitate a meaningful assessment of feasibility and safety. As a multicenter study, each participating center will include two groups (IG and CG), with 26 participants in each. Clinical parameters, severity, functionality, functional exercise capacity, muscle strength, and mortality will be assessed. The outcomes of Project 1 will be analyzed using parametric or non-parametric methods to compare the groups. Results will also be evaluated using logistic regression or linear regression analyses. Building on the findings of Project 1, the continuation of problem diagnosis and care process implementation within the institution, and potentially within the healthcare network, will be developed through Project 2. The care pathway proposal will be based on prioritization criteria such as magnitude, relevance, vulnerability, and costs, using the SWOT matrix (Strengths, Opportunities, Weaknesses, Threats). The intervention design will include objectives, activities, resources, and expected outcomes, along with proposed criteria for monitoring and evaluation. Activity descriptions will adhere to the 5W2H method (What, Why, Who, When, Where, How, How Much). Finally, the intervention's results will be tracked using SMART criteria (Specific, Measurable, Achievable, Relevant, Time-bound) to establish specific indicators within a defined timeframe.