Feasibility and Prognosis of Early Rehabilitation in Patients With ECMO
1 other identifier
interventional
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2021
CompletedFirst Posted
Study publicly available on registry
October 19, 2021
CompletedStudy Start
First participant enrolled
December 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedOctober 19, 2021
September 1, 2021
12 months
September 30, 2021
October 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
muscle ultrasound
The thickness of intercostal muscle and rectus femoris muscle was measured by ultrasound
7 days
Secondary Outcomes (1)
ECMO duration time
30 days
Study Arms (2)
Rehabilitation group
EXPERIMENTALcontrol group
NO INTERVENTIONadhere to standardized management guidelines for anticoagulation, ventilation, sedation specific to the MICU ECMO population
Interventions
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.
Eligibility Criteria
You may qualify if:
- ECMO time ≥1 day
- Aged older than16 years old and less than 70 years old
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- JinyanXinglead
Study Sites (1)
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266555, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
September 30, 2021
First Posted
October 19, 2021
Study Start
December 1, 2021
Primary Completion
November 30, 2022
Study Completion
November 30, 2022
Last Updated
October 19, 2021
Record last verified: 2021-09