Feasibility and Prognosis of Early Rehabilitation in Patients With ECMO

Study Overview
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Brief Summary
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ECMO is increasingly used in critically ill patients with severe circulatory and/or respiratory failure. Because of the catheterization of the femoral artery and femoral vein, usage of sedatives, and occasionally with neuromuscular blockers, ECMO patients are generally considered unsuitable for early activity. However, some recent retrospective studies and a small number of single-center, small-scale prospective studies have shown that early activity of ECMO patients is feasible, and early active activity is associated with recovery of independent function and reduction of delirium incidence.

Official Title
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Feasibility and Prognosis of Early Rehabilitation in Patients With Extracorporeal Membrane Oxygenation

Conditions
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Extracorporeal Membrane Oxygenation

Intervention / Treatment
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* Behavioral: rehabilation therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ECMO time ≥1 day Aged older than16 years old and less than 70 years old Exclusion Criteria: coma deep sedation muscle relaxation (RAAS-3-5) Active bleeding deep vein thrombosis High dose of vasoactive drugs unstable vital signs Acute stage of myocardial infarction (within 2d) Malignant arrhythmia pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rehabilitation group<br> | Behavioral: rehabilation therapy<br>* After comprehensive assessment by doctors, nurses and rehabilitation therapists, patients gradually begin rehabilitation treatment.IMS 0: no mobilisation or passively exercised by staff. IMS 1: sitting in bed and actively exercising .IMS 2: passively moved to chair without standing.IMS 3: sitting over edge of bed.IMS 4: standing in front of bed.IMS 5: transferring bed to chair.IMS 6: marching on spot.IMS 7: walking with assistance of more than one person.IMS 8: walking with assistance of one person.IMS 9: walking independently with a gait aid.IMS 10: walking independently without a gait aid.<br>|
| No Intervention: control group<br>adhere to standardized management guidelines for anticoagulation, ventilation, sedation specific to the MICU ECMO population | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle ultrasound | The thickness of intercostal muscle and rectus femoris muscle was measured by ultrasound | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ECMO duration time |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extracorporeal Membrane Oxygenation, early rehabilation, muscle ultrasound