An observational study in Intensive Care Unit Acquired Weakness and Intensive Care Unit Patients, sponsored by Claudia Aristizábal. Recruiting at 4 sites in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-23.
Sponsored by Claudia Aristizábal · Observational
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Intensive Care Unit Acquired Weakness (ICU-AW) is a common complication of critical illnesses, occurring in approximately 50% of ICU patients and is strongly associated with increased morbidity, physical impairments, and both short- and long-term mortality. The main characteristics of ICU-AW are symmetrical generalised muscle weakness affecting both respiratory and limb muscles; however, the clinical phenotype may differ depending on age, disease burden, length of ICU stay, and mechanical ventilation duration.
The objective of the present study is to evaluate the feasibility achieved and the safety outcomes reported in a cohort of critically ill patients who undergo early mobilisation and rehabilitation in intensive care units. This research is a multicentre prospective cohort study.
Prolonged immobilisation, mechanical ventilation, and sedation during critical illness have been associated with generalized muscle weakness, restricted joint mobility, pressure ulcers, critical illness neuropathies or acquired weakness, deep vein thrombosis (DVT), prolonged mechanical ventilation, psychological disorders, and cognitive impairment. Barriers to early mobilisation have been identified, including patient-related, institution-related, and physician-related barriers, and various strategies have been used to overcome these barriers and facilitate the smooth practice of early mobilisation.
Early mobilisation, initiated within 24-48 hours of Intensive Care Unit (ICU) admission, has been shown to be the best strategy for reducing ICU-acquired weakness (ICUAW). It includes a variety of interventions: passive for non-cooperative patients (e.g., positioning, passive joint mobilisation) and active-assisted or active for less or fully cooperative patients (e.g., active or active-assisted joint mobilisation, sitting on bed or chair, transfers, standing, ambulation). Several studies have provided evidence that progressive early mobilisation of adult ICU patients is feasible, safe, and can yield benefits including improved functional outcomes and reduced ICU and hospital stay durations.
Successful implementation of an early physical rehabilitation program in most ICUs requires a structured process to promote quality improvement. This involves a multidisciplinary approach including hospital administrators, ICU and rehabilitation leaders who support the program and promote a culture change within the ICU. It also requires assembling a multidisciplinary team including intensivists, nursing, clinical nutrition, physical medicine, and rehabilitation; establishing a common goal and shared expectation of early rehabilitation for all patients with focused efforts to identify and overcome barriers to achieving this goal; and obtaining basic equipment to facilitate early rehabilitation.
478 studies on the registry are indexed under Muscle Weakness; 74 are open to participants now.
This study's planned enrollment of 220 is above the median of 68 across 108 observational studies indexed under Muscle Weakness.
Browse Muscle Weakness studies →Claudia Aristizábal is the lead sponsor of 9 studies on the registry; 5 are open to participants now.
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Patients ≥ 18 years of age admitted to the intensive care units of Clínica Reina Sofía, Clínica Universitaria Colombia, Clínica Reina Sofia and Clínica Santa María del Lago in Bogotá.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients aged ≥ 18 years admitted to intensive care units and receiving the institutional early mobilisation protocol.
Other: Early mobilization and rehabilitation
In the initial assessment will be applied the ICU Mobility Scale, with the objective of establishing the patient\'s current level of function and determining the most appropriate type, intensity and duration of activity. The sessions, which will be conducted by a physiotherapist, will include therapeutic strategies such as bed exercises (both active and passive), electrical stimulation, use of an in-bed cycloergometer (for upper and lower limbs), sitting on the edge of the bed, bed transfers, bedside transfers from bed to chair, out-of-bed exercises, standing, and walking. The latter two activities are considered to be the most complex. Each session will last approximately 20 to 30 minutes and will be conducted once a day, on a daily basis throughout the patient\'s ICU stay. The last session wil be prior to discharge of the patient. During each session, the Borg Perception of Exertion Scale will be assessed in order to adjust the intensity of physical activity.
Viability
This is the number of sessions performed by the patient.
Time frame: During the intervention period commenced on the first day of admission to the ICU through study completion, an average of seven days.
Safety event
This is the number of safety events related with the intervention. The following safety events will be measured: Accidental removal of central venous catheter, accidental removal of endotracheal tube, accidental removal of arterial line, accidental removal of nasogastric or orogastric tube, accidental removal of bladder catheter, high or low blood pressure, tachycardia, bradycardia, arrhythmia, y polypnoea.
Time frame: During the intervention period commenced on the first day of admission to the ICU through study completion, an average of seven days.
Degree of ability achieved
It will be assessed using the ICU Mobility Scale.
Time frame: During the intervention period commenced on the first day of admission to the ICU through study completion, an average of seven days.
Heart rate
It will be measured with pulse oximeter.
Time frame: During the intervention period commenced on the first day of admission to the ICU through study completion, an average of seven days.
Respiratory rate
It will be measured with pulse oximeter.
Time frame: During the intervention period commenced on the first day of admission to the ICU through study completion, an average of seven days.
Started May 2024 (actual). Primary completion is estimated for Mar 2025, 10 months after the start.
Of 48 non-industry observational studies under Muscle Weakness, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 63. This study's planned 10 months is below that.
Counting every sponsor, half of 50 studies reached it within 26 months; a quarter within 12 and three quarters within 63.
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Claudia Aristizábal