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

• Grant number: 22/07841-0
• Support Opportunities: Research Projects - Thematic Grants
• Start date: June 01, 2024
• End date: May 31, 2029
• Field of knowledge: Health Sciences - Physiotherapy and Occupational Therapy
• Principal Investigator: Ada Clarice Gastaldi
• Grantee: Ada Clarice Gastaldi
• Host Institution: Faculdade de Medicina de Ribeirão Preto (FMRP). Universidade de São Paulo (USP). Ribeirão Preto , SP, Brazil
• Pesquisadores principais: Anamaria Siriani de Oliveira
• Associated researchers: Anderson Marliere Navarro ; Anibal Basile Filho ; Carol Hodgson ; Carolina Fu ; Elcio dos Santos Oliveira Vianna ; Ester Cecilia Wilches Luna ; Gisela Cristiane Miyamoto ; Hugo Celso Dutra de Souza ; Janne Marques Silveira ; José Carlos Farias Alves Filho ; Livia Arcêncio do Amaral ; Marcel Koenigkam Santos ; Marcos Gontijo da Silva ; Omar Usmani
• Associated scholarship(s): 25/06278-8 - Effects of an intensive mobilization protocol and a care protocol Usual in the functionality of mechanically ventilated critical patients, BP.IC; 25/06275-9 - Comparing the assessment of respiratory mechanics of patients undergoing intensive mobilization and usual care in the Intensive Care Unit (ICU), BP.IC; 25/04782-0 - Comparison of an early and intensive hospital mobilization protocol and usual care in hospitalized patients during and after Intensive care unit admission and invasive mechanical ventilation, BP.TT; + associated scholarships 25/06522-6 - Comparison of a face-to-face cardiorespiratory rehabilitation protocol and a booklet of home guidance on quality of life in patients after hospitalization who were on mechanical ventilation., BP.IC; 25/06523-2 - Effects of a post-hospitalization rehabilitation program on indicators of sarcopenia in critically ill patients undergoing invasive mechanical ventilation, BP.IC; 24/22927-3 - Comparison of an Early and Intensive Mobilization Protocol Versus Standard Care in Critically Ill Patients Undergoing Invasive Mechanical Ventilation: A Multicenter Clinical Trial., BP.PD; 24/23468-2 - Cost-effectiveness of a rehabilitation program for patients undergoing mechanical ventilation, from the ICU to the post-hospital phase., BP.PD - associated scholarships

Abstract

Advances in knowledge have contributed to the increase in the number of patients who survive to prolonged hospitalization in an Intensive Care Unit (ICU), and, among them, critically ill patients who progress to acute respiratory failure and the need for mechanical ventilation. These individuals have their mobility restricted to the bed, and may present pulmonary and systemic complications, such as ICU-Acquired Muscle Weakness (ICU-AW), which increases the chances of leading to reduced functional capacity or death. Early mobilization in the ICU has shown benefits, such as functional improvement and reduced length of stay, but still with a low level of evidence. However, the type and intensity of exercise still need to be better defined and previous protocols did not offer continuous program from the ICU to the ward and subsequent outpatient rehabilitation to these patients, which is considered a limitation in some studies. Objective: To investigate the effects of an early and intensive hospital mobilization and post-hospitalization rehabilitation program on indicators of functionality, inflammation and mortality in critically ill patients undergoing invasive mechanical ventilation.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 Faculty of Medicine of Ribeirão Preto, University of São Paulo. Patients of both genders over 21 years old will be recruited under invasive mechanical ventilation for at least 24 hours; patients will be allocated into: Intervention Group (IG) that will participate in the intensive hospital mobilization protocol and Control Group (CG) that will be maintained under routine care limited to 10 minutes of mobilization per day; after being discharged to the ward, the volunteers will follow up according to their respective groups. After hospital discharge, the participants will be randomized again into the Intervention Group (IGor) and the Intervention Group (IGreab) and, likewise, the Control Group will be divided into CGor and CGreab, with the main outcome being muscle assessment, functional capacity of exercise, and cost/effectiveness ratio. Volunteers will be monitored at 1, 3 and 6 months after hospital discharge. According to the sample calculation, a minimum of 26 subjects per group was considered necessary to facilitate a meaningful assessment of feasibility and safety. For the multicenter study, each of the participating centers will include 2 groups (GI and GC) of 26 subjects each group. All analyzed variables will be described in the form of graphs and tables, separated by groups. Outcomes will be analyzed using parametric or non-parametric methods for comparison between groups. The results will also be analyzed by logistic regression or linear regression and will be conducted by an experienced statistician. (AU)