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

NCT ID: NCT04918498

Last Updated: 2021-07-15

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

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-12-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Extracorporeal Membrane Oxygenation Complication

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Non-contemporaneous control
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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routine treatment

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Group Type PLACEBO_COMPARATOR

routine treatment

Intervention Type BEHAVIORAL

provide routine nursing and rehabilitation program

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.

Group Type EXPERIMENTAL

early physiotherapy programs

Intervention Type BEHAVIORAL

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

Interventions

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early physiotherapy programs

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

Intervention Type BEHAVIORAL

routine treatment

provide routine nursing and rehabilitation program

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Second Affiliated Hospital of Jiaxing University

OTHER

Sponsor Role collaborator

Yuhang Hospital

UNKNOWN

Sponsor Role collaborator

Changxing People's Hospital

OTHER

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fei Zeng

Role: STUDY_CHAIR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

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SAHZhejiangU

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fei Zeng

Role: CONTACT

13757119536

Facility Contacts

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Fei Zeng

Role: primary

13757119536

Other Identifiers

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2021-0205

Identifier Type: -

Identifier Source: org_study_id

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