An observational study in Intensive Care, Mechanical Ventilation and Rehabilitation, sponsored by Wuhan University. Recruiting at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by Wuhan University · Observational
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.
An increasing amount of evidence from evidence-based medicine suggests that early rehabilitation intervention (including early active and passive exercises, position management, pulmonary rehabilitation, etc.) for mechanical ventilation patients is safe and feasible, and can promote certain degree of functional recovery and reduce the length of stay in the intensive care unit (ICU). However, the differences in consciousness state, muscle strength, respiratory function, and activity of daily living (ADL) among patients who are discharged from the ICU after condition stabilization are very large, even some patients did not obtain obvious benefits. Therefore, how to identify which patients may have better benefit from early rehabilitation intervention is a key issue that needs to be focused on in ICU.
This study used "Transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD)" as the guideline. Survivors undergoing mechanical ventilation in the ICU were recruited as the participants, whether patients gained progress in ADL function at different time points after receiving early rehabilitation intervention in the ICU was used as the outcome which is a time-to-event indicator. Demographic data, clinical diagnostic data and disease intervention data of the subjects were collected as alternative predictors. Variable transformation and variable screening were used to find predictors that could predict the outcome. The process of constructing clinical predictive models is completed by fitting models through regression equations and machine learning algorithms, internal validation, external validation, and clinical value assessment. The model with the best prediction efficiency is selected based on the differentiation and calibration of different models after validation. This model will be presented with a nomogram or a web app. The application of this clinical predictive model will identify whether and when this patient can received better recovery on ADL after receiving early rehabilitation intervention, so as to further optimize the timing of early intervention in rehabilitation and improve his survival quality.
Wuhan University is the lead sponsor of 46 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
ICU patients received mechanical ventilation and early rehabilitation interventions, regardless of the primary diagnosis.
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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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Survivors of ICU with Mechanical Ventilation are individuals who have been treated in an intensive care unit (ICU) and require the use of a mechanical ventilator to assist their breathing with no mortality events occurring.
Other: Early rehabilitation intervention
Based 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)
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.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Aug 2024 (actual). Primary completion is estimated for Oct 2026, 26 months after the start.
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