CaRe-ECMO Program on ECMO Weaning (CaRe-ECMO)

March 15, 2022 updated by: Yu Zheng, The First Affiliated Hospital with Nanjing Medical University

Impact of Cardiopulmonary Rehabilitation on Weaning of Extracorporeal Membrane Oxygenation (CaRe-ECMO): a Prospective Multidisciplinary Randomized Controlled Clinical Trial

Mortality of patients suffering critical illness has been dramatically improved with advanced technological development of extracorporeal membrane oxygenation (ECMO) therapy. However, weaning rate stayed low in a majority of ECMO-supported patients. As one of several options, cardiopulmonary rehabilitation serves as effective intervention in the improvement of cardiovascular and respiratory function in various major critical illness. Nonetheless, its roles in facilitating ECMO weaning has not yet been explored. The purpose of this study is to investigate the effectiveness of cardiopulmonary rehabilitation on rate of ready for weaning in ECMO-supported patients (CaRe-ECMO).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Studies have documented that rate of mechanical ventilation weaning was improved in patients received early rehabilitation intervention while its effectiveness in ECMO weaning remains unclear. This inspires us to hypothesize that if the medical rationale is based on its assumed benefits on cardiac function and oxygenation, then cardiopulmonary rehabilitation may subsequently contribute to earlier weaning of ECMO. The "CaRe-ECMO" trial is a prospective, multidisciplinary, randomized controlled, parallel group, clinical trial. Cardiopulmonary rehabilitation program which encompasses six evidence-based components:1) positioning; 2) passive range of motion (PROM) training; 3) neuromuscular electronic stimulation (NMES); 4) surface electrical phrenic nerve stimulation (SEPNS); 5) respiratory PNF techniques 6) airway clearance techniques; 366 ECMO-supported patients in department of emergency medicine will be randomized to control and CaRe-ECMO group. CaRe-ECMO group will be treated with usual care, ECMO therapy, and cardiopulmonary rehabilitation program. Usual care normally comprises pharmacotherapy, mechanical ventilation, continuous renal replacement therapy (CRRT), intra-aortic balloon pump (IABP), and specific nursing for ECMO therapy and their original injuries, as appropriate. Control group will be treated with usual care, ECMO therapy. The primary objective of the CaRe-ECMO trial is to investigate the impact of cardiopulmonary rehabilitation combined with usual care on rate of ready for ECMO weaning at CaRe-ECMO Day 7, when compared to usual care alone. Secondary objectives are to evaluate the effects of cardiopulmonary rehabilitation on rate of ECMO weaning, total length of ready for ECMO weaning, total length of ECMO weaning, rate of mechanical ventilation weaning, total length of mechanical ventilation, all-cause mortality, rate of major post-ECMO complications, diaphragmatic thickness and mobility, ECMO Unit length of stay (LOS), total hospital LOS, total cost for hospitalization, cerebral performance category (CPC) index, activity of daily living (ADL), and health related quality of life (HRQoL). The CaRe-ECMO trial is designed to test the hypothesis that early cardiopulmonary rehabilitation can accelerate weaning of ECMO-supported patients. If CaRe-ECMO trial results in superior improvement in primary and secondary outcomes, it will offer an innovative treatment option for ECMO-supported patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
366

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • The First Affiliated Hospital of Nanjing Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xufeng Chen, M.D.
        • Principal Investigator:
          • Jingsong Zhang, M.D.
        • Principal Investigator:
          • Xiao Lu, M.D.
        • Sub-Investigator:
          • Yu Zheng, M.D.
        • Sub-Investigator:
          • Hao Sun, M.D.
        • Sub-Investigator:
          • Yong Mei, M.D.
        • Sub-Investigator:
          • Yongxia Gao, MSc.
        • Sub-Investigator:
          • Jinru Lv, MSc.
        • Sub-Investigator:
          • Dijia Pan, MSc.
        • Sub-Investigator:
          • Lu Wang, Mphil.
        • Sub-Investigator:
          • Xintong Zhang, M.D.
        • Sub-Investigator:
          • Deliang Hu, MSc.
        • Sub-Investigator:
          • Feng Sun, M.D.
        • Sub-Investigator:
          • Wei Li, M.D.
        • Sub-Investigator:
          • Gang Zhang, MSc.
        • Sub-Investigator:
          • Huazhong Zhang, MSc.
        • Sub-Investigator:
          • Ying Chen, BSc.
        • Sub-Investigator:
          • Shenrui Wang, BSc.
        • Sub-Investigator:
          • Zhongman Zhang, MSc.
        • Sub-Investigator:
          • Baoquan Li, BSc.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

1) Aged 18yr or order 2) Eligible for receiving ECMO (veno-venous [VV] or veno-arterial [VA]) therapy 3) With mechanical ventilation 4) With stable condition and eligible for cardiopulmonary rehabilitation after 72 hours of ECMO 5) With no contraindications for cardiopulmonary rehabilitation 6) With a life expectancy of more than 3 days 7) Sign informed consent form by the guardian

Exclusion Criteria:

1) Pregnant 2) Use ECMO as a bridge to recovery or definitive treatment (e.g. lung transplantation or heart transplantation) 3) Enrolled in another trial previously

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: CaRe-ECMO group
Patients in the CaRe-ECMO group will be treated with usual care, ECMO therapy, and cardiopulmonary rehabilitation program.
Procedure: Cardiopulmonary rehabilitation
Cardiopulmonary rehabilitation program which encompasses six evidence-based components according to literature review: 1) positioning; 2) passive range of motion (PROM) training; 3) neuromuscular electronic stimulation (NMES); 4) surface electrical phrenic nerve stimulation (SEPNS); 5) PNF techniques; and 6) airway clearance techniques; Usual care normally comprises pharmacotherapy, mechanical ventilation, continuous renal replacement therapy (CRRT), intra-aortic balloon pump (IABP), and specific nursing for ECMO therapy and their original injuries, as appropriate.
Procedure: Usual care
Control group will be treated with usual care and ECMO therapy. Usual care normally comprises pharmacotherapy, mechanical ventilation, continuous renal replacement therapy (CRRT), intra-aortic balloon pump (IABP), and specific nursing for ECMO therapy and their original injuries, as appropriate.
Placebo Comparator: Control group
Usual care and ECMO therapy
Procedure: Usual care
Control group will be treated with usual care and ECMO therapy. Usual care normally comprises pharmacotherapy, mechanical ventilation, continuous renal replacement therapy (CRRT), intra-aortic balloon pump (IABP), and specific nursing for ECMO therapy and their original injuries, as appropriate.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of ready for ECMO weaning at CaRe-ECMO Day 7
Time Frame: CaRe-ECMO Day 7
Rate of ready for ECMO weaning will be calculated 7 days after cardiopulmonary rehabilitation delivery
CaRe-ECMO Day 7

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of ready for ECMO weaning
Time Frame: CaRe-ECMO Day 14, 30 and 90
Rate of ready for ECMO weaning will be calculated 14, 30 and 90 days after cardiopulmonary rehabilitation delivery
CaRe-ECMO Day 14, 30 and 90
Rate of ECMO weaning
Time Frame: CaRe-ECMO Day 7, 14, 30 and 90
Rate of ECMO weaning will be calculated according to date of ECMO weaning fulfilled
CaRe-ECMO Day 7, 14, 30 and 90
Total length of ready for ECMO weaning
Time Frame: From date of ECMO initiation until the date of ready for ECMO weaning, assessed up to CaRe-ECMO Day 90
Total length of ready for ECMO weaning refers to exact length in day till patients fulfill all criteria of ready for ECMO weaning according to daily checkout records
From date of ECMO initiation until the date of ready for ECMO weaning, assessed up to CaRe-ECMO Day 90
Total length of ECMO weaning
Time Frame: From date of ECMO initiation until the date of ECMO weaning, assessed up to CaRe-ECMO Day 90
Total length of ECMO weaning refers to exact length in day for patients treated with ECMO therapy
From date of ECMO initiation until the date of ECMO weaning, assessed up to CaRe-ECMO Day 90
Rate of mechanical ventilation weaning
Time Frame: CaRe-ECMO Day 7, 14, 30 and 90
Rate of mechanical ventilation weaning will be calculated according to date of mechanical ventilation weaning fulfilled. Daily screening of mechanical ventilation weaning will be strictly performed with checklist
CaRe-ECMO Day 7, 14, 30 and 90
Total length of mechanical ventilation
Time Frame: From date of mechanical ventilation initiation until the date of mechanical ventilation weaning, assessed up to CaRe-ECMO Day 90
Total length of mechanical ventilation refers to exact length in day for patients treated with mechanical ventilation
From date of mechanical ventilation initiation until the date of mechanical ventilation weaning, assessed up to CaRe-ECMO Day 90
All-cause mortality
Time Frame: CaRe-ECMO Day 7, 14, 30 and 90
All-cause mortality is defined as rate of death due to any causes and will be calculated according to date of death
CaRe-ECMO Day 7, 14, 30 and 90
Major complications
Time Frame: CaRe-ECMO Day 7, 14, 30 and 90
Rate of complications occurred after ECMO, including but not limited to ECMO related complications (e.g., thromboembolism), mechanical ventilation related complications (e.g., pneumonia), newly developed myocardial infarction, acute kidney injury, neurologic events (e.g., stroke, seizures), and multiple organ failure
CaRe-ECMO Day 7, 14, 30 and 90
Diaphragmatic thickness and mobility
Time Frame: Every three days, assessed up to CaRe-ECMO Day 90
Diaphragmatic thickness and mobility refer to ultrasound guided evaluation of diaphragmatic thickness and mobility under M mode
Every three days, assessed up to CaRe-ECMO Day 90
ECMO Unit length of stay (LOS)
Time Frame: Discharge day (discharge from ECMO Unit), assessed up to CaRe-ECMO Day 90
ECMO Unit length of stay (LOS) accounts for length in day for patients' stay in the ECMO Unit
Discharge day (discharge from ECMO Unit), assessed up to CaRe-ECMO Day 90
Total hospital length of stay
Time Frame: Discharge day (discharge from hospital), assessed up to CaRe-ECMO Day 90
Total hospital LOS accounts for total hospital LOS in day for patients' stay in both ECMO Unit and other departments
Discharge day (discharge from hospital), assessed up to CaRe-ECMO Day 90
Total cost for hospitalization
Time Frame: Discharge day (discharge from hospital), assessed up to CaRe-ECMO Day 90
Total cost for hospitalization will be calculated by addition of the cost of all units and departments admission
Discharge day (discharge from hospital), assessed up to CaRe-ECMO Day 90
Cerebral performance category (CPC) index
Time Frame: CaRe-ECMO Day 7, 14, 30, 90 and discharge day (discharge from ECMO Unit), assessed up to CaRe-ECMO Day 90
Cerebral performance category (CPC) index will be recorded, for those successfully weaning of ECMO, to reflect post-ECMO neurological status
CaRe-ECMO Day 7, 14, 30, 90 and discharge day (discharge from ECMO Unit), assessed up to CaRe-ECMO Day 90
Activity of daily living (ADL)
Time Frame: CaRe-ECMO Day 7, 14, 30, 90 and discharge day (discharge from ECMO Unit), assessed up to CaRe-ECMO Day 90
Activity of daily living (ADL) will be evaluated, for those successfully weaning of ECMO, with Katz Index
CaRe-ECMO Day 7, 14, 30, 90 and discharge day (discharge from ECMO Unit), assessed up to CaRe-ECMO Day 90
Health related quality of life (HRQoL)
Time Frame: CaRe-ECMO Day 7, 14, 30, 90 and discharge day (discharge from ECMO Unit), assessed up to CaRe-ECMO Day 90
Health related quality of life (HRQoL) will be measured, for those successfully weaning of ECMO, with SF-12
CaRe-ECMO Day 7, 14, 30, 90 and discharge day (discharge from ECMO Unit), assessed up to CaRe-ECMO Day 90

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Affiliated Hospital with Nanjing Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xiao Lu, M.D., The First Affiliated Hospital with Nanjing Medical University
  • Principal Investigator: Jingsong Zhang, M.D., The First Affiliated Hospital with Nanjing Medical University
  • Principal Investigator: Xufeng Chen, M.D., The First Affiliated Hospital with Nanjing Medical 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CaRe-ECMO

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.

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