Application of Early Physical Therapy Regimens in Patients With Veno-venos Extracorporeal Membrane Oxygenation (VV-ECMO)

July 13, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
Promote early recovery through the application of early physiotherapy programs for VV-ECMO patients

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • SAHZhejiangU
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: routine treatment
Review the collection of patient-related clinical data, collation of clinical data and outcome indicators
Behavioral: routine treatment
provide routine nursing and rehabilitation program
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
establishment of multidisciplinary teams, safety assessment, early activity physiotherapy and respiratory physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VV-ECMO auxiliary time
Time Frame: 1 year
the time for VV-ECMO auxiliary
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

The Second Affiliated Hospital of Jiaxing University
Changxing People's Hospital
Yuhang Hospital

Investigators

  • Study Chair: Fei Zeng, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Anticipated)

September 30, 2022

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

May 31, 2021

First Submitted That Met QC Criteria

June 2, 2021

First Posted (Actual)

June 8, 2021

Study Record Updates

Last Update Posted (Actual)

July 15, 2021

Last Update Submitted That Met QC Criteria

July 13, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2021-0205 (Other Identifier: M D Anderson Cancer Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Extracorporeal Membrane Oxygenation Complication

Clinical Trials on routine treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe