Feasibility and Safety of Early Mobilization and Rehabilitation in Intensive Care Unit Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorClaudia Aristizábal
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients ≥ 18 years of age admitted to the intensive care units.
Disqualifiers
Patients requiring extracorporeal membrane oxygenation (ECMO).
Patients without indication for early mobilisation in the ICU (severe hemodynamic instability, acute brain or spinal injury with rest orders, anaemia (Hb <8 mg/dl), thrombocytopenia (platelets <50,000), active systemic inflammatory response according to institutional protocols).
Patients in the postoperative period of cardiac transplantation.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Early mobilization and rehabilitation
Other interventionIn 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.
Treatment groups
220 Participants
are divided into 1 treatment groupGroup A: Intensive care unit patients1 intervention
Trial outcomes
Primary outcomes
1
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.2
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.Secondary outcomes
1
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.Other outcomes
1
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.2
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Claudia Aristizábal
Lead sponsor
Sanitas University
Sponsor institution
Source ClinicalTrials.gov