Effects of an intensive mobilization protocol and a care protocol Usual in the functionality of mechanically ventilated critical patients

• Grant number: 25/06278-8
• 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: Kemily Tauane Siminato
• 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 the increase in the number ofpatients who survive prolonged stay in an Intensive Care Unit (ICU), and, among them, severe patients who evolve to Acute Respiratory Failure(IRpA) and the need for mechanical ventilation (MV). These individuals have their mobilitybedridden, and may course with pulmonary and systemic complications, such as Weakness Acquired Muscle Disease in the ICU (FMA-ICU), which increases the chances of progressing with reducedfunctional capacity or death. Early mobilization in the ICU has shown benefits, such as functional improvement and reduction of hospitalization days, but still with a low level of evidence. However, the type and intensity of exercise still needs to be better and the previous protocols did not offer continuous ICU follow-up for ward and subsequent outpatient rehabilitation to these patients, being considered a limitation in some works. Objective: To compare the effects of a intensive mobilization and a protocol of usual care in the functionality of patients mechanically ventilated. Methods: This is a Controlled Clinical Trial Randomized Blinded that will be conducted in the Intensive Care Units of the Hospital das Clinics and the Emergency Unit of the Medical School of Ribeirão Preto University of São Paulo. Patients of both sexes over 21 years of age will be recruited under invasive mechanical ventilation for at least 24 hours; Patients will be allocated to: Intervention Group (IG) that will participate in the hospital intensive mobilization protocol and Control Group (CG) who will be kept under usual sector care limited to 10 minutes mobilization per day; After discharge to the ward, volunteers will maintain follow-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. Data from the muscle and capacity assessment will be analyzed functional exercises, through the MRC-SS, Handgrip, Ultrasound of quadriceps and Arm and thigh circumference, in addition to the application of the EQ-5D-5L and HADS. All the variables analyzed will be described in the form of graphs and tables, separated by groups. Outcomes will be analyzed using parametric or parametric methods. nonparametric for comparison between the groups. The results will also be analyzed by logistic regression or linear regression and will be conducted by a professional statistician experienced.