Feasibility and Prognosis of Early Rehabilitation in Patients With ECMO

NCT ID: NCT05083624

Last Updated: 2021-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2022-11-30

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.

Detailed Description

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Conditions

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Extracorporeal Membrane Oxygenation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Rehabilitation group

Group Type EXPERIMENTAL

rehabilation therapy

Intervention Type BEHAVIORAL

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.

control group

adhere to standardized management guidelines for anticoagulation, ventilation, sedation specific to the MICU ECMO population

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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rehabilation therapy

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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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JinyanXing

OTHER

Sponsor Role lead

Responsible Party

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JinyanXing

Director

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Site Status

Countries

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China

Central Contacts

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Jinyan Xing, Doctor

Role: CONTACT

86-0532-82919386 ext. 82919386

Other Identifiers

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QYFYKYLL9121011920

Identifier Type: -

Identifier Source: org_study_id