NCT04918498

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 8, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

July 15, 2021

Status Verified

May 1, 2021

Enrollment Period

1.7 years

First QC Date

May 31, 2021

Last Update Submit

July 13, 2021

Conditions

Extracorporeal Membrane Oxygenation Complication

Outcome Measures

Primary Outcomes (1)

  • VV-ECMO auxiliary time

    the time for VV-ECMO auxiliary

    1 year

Study Arms (2)

routine treatment

PLACEBO COMPARATOR

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

Behavioral: routine treatment

Experimental group

EXPERIMENTAL

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

early physiotherapy programsBEHAVIORAL

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

Experimental group
routine treatmentBEHAVIORAL

provide routine nursing and rehabilitation program

routine treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SAHZhejiangU

Hangzhou, Zhejiang, 310000, China

RECRUITING

Study Officials

  • Fei Zeng

    Second Affiliated Hospital, School of Medicine, Zhejiang University

    STUDY CHAIR

Central Study Contacts

Fei Zeng

CONTACT

13757119536zengfei@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Model Details: Non-contemporaneous control
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2021

First Posted

June 8, 2021

Study Start

January 1, 2021

Primary Completion

September 30, 2022

Study Completion

December 30, 2022

Last Updated

July 15, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)