Safety of early mobilisation in the intensive care unit: a prospective and multicentre cohort study protocol.
Henry Mauricio Parada-Gereda, Ricardo Merchán-Chaverra, Jorge Medina-Parra...
https://pubmed.ncbi.nlm.nih.gov/40858383Actively Recruiting
Age: 18Years +
All Genders
ID06653998
Feasibility and Safety of Early Mobilization and Rehabilitation in Intensive Care Unit Patients A Prospective, Multicenter Study
Led by Claudia Aristizábal · Updated on 2024-10-23
220
Participants Needed
4
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Intensive Care Unit Acquired Weakness (ICU-AW) is a frequent problem in critically ill patients, affecting about half of those in intensive care units. It causes widespread muscle weakness, including respiratory and limb muscles, which varies based on factors like age, illness severity, ICU stay length, and mechanical ventilation duration. This multicenter prospective cohort study aims to evaluate how feasible and safe early mobilisation and rehabilitation are for ICU patients. The study involves early mobilisation started within 24 to 48 hours of ICU admission, using passive methods for non-cooperative patients and active or assisted exercises for cooperative patients. These include joint mobilisation, sitting, transfers, standing, and walking. Sessions last 20 to 30 minutes daily and are led by physiotherapists using tools such as the ICU Mobility Scale and Borg Perception of Exertion Scale to tailor activity intensity. The intervention continues daily throughout the ICU stay until patient discharge. Participants will be assessed during the intervention period, averaging seven days from ICU admission to study completion. Researchers will monitor the feasibility of the early mobilisation program and safety events during this time. They will also evaluate the degree of physical ability achieved. The study involves multidisciplinary collaboration to support and implement the rehabilitation program effectively in the ICU setting.
CONDITIONS
Brief Title
Feasibility and Safety of Early Mobilization and Rehabilitation in Intensive Care Unit Patients
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age or older admitted to the intensive care units.
You will not qualify if you...
- Patients requiring extracorporeal membrane oxygenation (ECMO).
- Patients with severe hemodynamic instability.
- Patients with acute brain or spinal injury requiring rest.
- Patients with anemia (Hb <8 mg/dl).
- Patients with thrombocytopenia (platelets <50,000).
- Patients with active systemic inflammatory response.
- Patients in the postoperative period of cardiac transplantation.
AI-Screening
AI-Powered Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Monitoring
Duration - Average of 7 days
Participants are observed while receiving early mobilization and rehabilitation during their stay in the Intensive Care Unit (ICU).
Daily sessions lasting 20 to 30 minutes throughout the ICU stay
Trial Site Locations
Total: 4 locations
1
Clínica Reina Sofia Pediátrica y Mujer
Bogotá, Bogota D.C., Colombia, 110111
Actively Recruiting
2
Clinica Univesitaria Colombia
Bogotá, Bogota D.C., Colombia
Actively Recruiting
3
Clínica Infantil Santa María del Lago
Bogotá, Bogota D.C., Colombia
Actively Recruiting
4
Clínica Reina Sofia
Bogotá, Bogota D.C., Colombia
Actively Recruiting
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How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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