Feasibility and Prognosis of Early Rehabilitation in Patients With ECMO

Extracorporeal Membrane Oxygenation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05083624
• Other study ID #: QYFYKYLL9121011920
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: November 30, 2022

Study information

• Verified date: September 2021
• Source: The Affiliated Hospital of Qingdao University
• Contact: Jinyan Xing, Doctor
• Phone: 86-0532-82919386
• Email: xingjy[@]qdu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Extracorporeal Membrane Oxygenation

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
JinyanXing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	muscle ultrasound	The thickness of intercostal muscle and rectus femoris muscle was measured by ultrasound	7 days
Secondary	ECMO duration time		30 days