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Status unknownNCT04918498VV-ECMOUpdated Jul 15, 2021

Application of Early Physical Therapy Regimens in Patients With Veno-venos Extracorporeal Membrane Oxygenation

An interventional study of early physiotherapy programs and routine treatment in Extracorporeal Membrane Oxygenation Complication, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-15.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified May 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jan 2021, registered May 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

Promote early recovery through the application of early physiotherapy programs for VV-ECMO patients

Read the detailed description

This study is intended to construct early physiotherapy programs for VV-ECMO patients, including multidisciplinary team building, safety assessment, early active physiotherapy, respiratory physiotherapy, with a view to promoting early recovery of patients, early withdrawal of ventilator-assisted ventilation, shortening ECMO auxiliary time, improving patients' exercise level and respiratory function, reducing complications, and improving the quality of near-term and long-term survival.

02

Conditions studied

  • Extracorporeal Membrane Oxygenation Complication
03

In context

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • VV-ECMO assisted support
  • lung failure (e.g. ARDS)
  • age ≥18 years
  • sober
  • informed consent to this study

Exclusion criteria

Exclusion Criteria:

  • unstable blood flow mechanics
  • active bleeding
  • mental disorders that do not work together
  • people waiting for lung transplants
  • people at the end of life (e.g. advanced lung cancer)
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
34 participants (estimated)

Study arms

  • Placebo comparator
    routine treatment

    Review the collection of patient-related clinical data, collation of clinical data and outcome indicators

    Behavioral: routine treatment

  • Experimental
    Experimental group

    Implement early physiotherapy programs. The early physiotherapy program for VV-ECMO patients mainly includes the establishment of multidisciplinary teams, safety assessment, early activity physiotherapy and respiratory physiotherapy.

    Behavioral: early physiotherapy programs

Interventions

  • Behavioralearly physiotherapy programs

    establishment of multidisciplinary teams, safety assessment, early activity physiotherapy and respiratory physiotherapy

  • Behavioralroutine treatment

    provide routine nursing and rehabilitation program

06

What researchers measure

Primary outcomes

  1. VV-ECMO auxiliary time

    the time for VV-ECMO auxiliary

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • SAHZhejiangU
    Hangzhou, Zhejiang 310000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04918498
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
The Second Affiliated Hospital of Jiaxing University, Yuhang Hospital, Changxing People's Hospital
Responsible party
Sponsor
First posted
Jun 8, 2021
Start date
Jan 1, 2021
Primary completion
Sep 30, 2022 (estimated)
Completion
Dec 30, 2022 (estimated)
Last update
Jul 15, 2021

Study contacts

Fei Zeng
Contact
zengfei@zju.edu.cn
13757119536
Fei Zeng
study chair · Second Affiliated Hospital, School of Medicine, Zhejiang University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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