Predictive Algorithms for Critical Rehabilitation Outcomes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorWuhan University
About this trial
An increasing amount of evidence from evidence-based medicine indicates that early rehabilitation intervention for patients receiving mechanical ventilation is safe and feasible, and can promote functional recovery and reduce hospital stay. However, the conscious state, respiratory function, and daily living activities of these patients after being discharged from the ICU vary greatly, and some patients do not show obvious benefits. How to identify which patients may have benefit from early rehabilitation is a key issue that needs to be addressed in critical care rehabilitation. This study aims to investigate the clinical data related to the disease of the ICU survivors who received mechanical ventilation as the research object, by collecting their clinical data when receiving early rehabilitation intervention, and constructing a clinical prediction model for the efficacy of early rehabilitation intervention in the ICU through the selection of optimal regression equation or machine learning algorithm. The application of this model can effectively determine whether ICU inpatients need early rehabilitation intervention, thereby reducing complication rates and improving their quality of life.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age older than 18 years;
Received mechanical ventilation, including endotracheal intubation and tracheostomy, during ICU admission;
Met the rehabilitation intervention indications outlined in the "Chinese Expert Consensus on Neurocritical Rehabilitation" during ICU admission and underwent corresponding early rehabilitation interventions, including but not limited to arousal therapy for consciousness disorders, early active/passive mobilization, comprehensive pulmonary rehabilitation, etc.;
No mortality events occurred during ICU admission;
Disqualifiers
Pediatric patients under 18 years of age;
Hospitalized patients in the ICU who did not receive mechanical ventilation;
Patients in the ICU who did not undergo early rehabilitation interventions;
mortality events occurred during ICU admission;
Trial population
ICU patients received mechanical ventilation and early rehabilitation interventions, regardless of the primary diagnosis.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Early rehabilitation intervention
Other interventionBased on the indications for early rehabilitation intervention outlined in the "Chinese Expert Consensus on Neurological Critical Care Rehabilitation," early rehabilitation interventions are categorized into three stages according to the patient's consciousness level (GCS score), degree of cooperation (S5Q score), and sedation status (RASS score)
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: Survivors of ICU with Mechanical Ventilation1 intervention
Trial outcomes
Primary outcomes
1
Functional Independence Measure (FIM) scale
The Functional Independence Measure (FIM) scale is a widely used tool designed to assess an individual's level of disability and functional independence in activities of daily living (ADLs). The FIM scale consists of 18 items divided into two main categories: \*\*self-care\*\* and \*\*mobility\*\*, each evaluating specific tasks such as eating, bathing, dressing, and transferring. Each item is scored on a scale from 1 to 7, where: * 1 indicates total dependence (the individual requires assistance), * 7 indicates complete independence (the individual performs the task safely and independently). The total FIM score can range from 18 to 126, with higher scores representing greater functional independence levels.
Time frame
From date of enrollment until the date of ADL improvement (FIM increase ≥ 5) or date of participants are transferred out of the ICU. FIM score was assessed every other day after treatment starts and up to 6 weeks.Sponsors and contacts
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Wuhan University
Lead sponsor
General Hospital of the Yangtze River Shipping/Wuhan Brain Hospital
Collaborator
Wuhan Wuchang Hospital
Collaborator
Source ClinicalTrials.gov