Comparing the assessment of respiratory mechanics of patients undergoing intensive mobilization and usual care in the Intensive Care Unit (ICU)

• Grant number: 25/06275-9
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: June 01, 2025
• End date: May 31, 2026
• Field of knowledge: Health Sciences - Physiotherapy and Occupational Therapy
• Principal Investigator: Ada Clarice Gastaldi
• Grantee: Laís Martins Caires
• 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 knowledge have contributed to an increase in the number of patients who survive prolonged hospitalization in an Intensive Care Unit (ICU), including critically ill patients who progress to Acute Respiratory Failure (ARF) and the need for mechanical ventilation (MV). These individuals have their mobility restricted to the bed, and can develop pulmonary and systemic complications, such as Acquired Muscle Weakness in the ICU (AMF-ICU), which increases the chances of developing reduced functional capacity or death. Early mobilization in the ICU has shown benefits, such as functional improvement and shorter hospital stays, although the level of evidence is still low. However, the type and intensity of exercise still needs to be better defined and previous protocols have not offered continuous follow-up from the ICU to the ward and subsequent outpatient rehabilitation for these patients, which is considered a limitation in some studies. Objective: To compare the assessment of respiratory mechanics of patients undergoing early intensive mobilization and usual ICU care. Methods: This is a Blinded Randomized Controlled Clinical Trial that will be conducted in the Intensive Care Units of the Hospital das Clínicas and the Emergency Unit of the Ribeirão Preto Medical School of the University of São Paulo. Patients of both sexes over the age of 21 under invasive mechanical ventilation for at least 24 hours will be recruited; the patients will be allocated into: Intervention Group (IG) which will participate in the intensive hospital mobilization protocol and Control Group (CG) which will be kept under the usual care of the sector limited to 10 minutes of mobilization per day; after discharge to the ward the volunteers will be followed up according to their respective groups. According to the sample calculation, a minimum of 26 individuals per group was considered necessary to facilitate a meaningful assessment of feasibility and safety. The pulmonary function and quality of life of the volunteers included in the study will be assessed using spirometry, impulse oscillometry and the EQ-5D-5L and HADS questionnaires. All the variables analyzed will be described in the form of graphs and tables, separated by group. The outcomes will be analyzed using parametric or non-parametric methods to compare the groups. The results will also be analyzed by logistic regression or linear regression and will be conducted by an experienced statistician.