CaRe-ECMO Program on ECMO Weaning

NCT05035797 | Unknown DMC

• 1 other identifier: CaRe-ECMO
• Study Type: interventional
• Target: 366
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Critical Illness

Keywords

Extracorporeal Membrane Oxygenation; Cardiopulmonary Rehabilitation; Weaning; Multidisciplinary; Randomized controlled trial; Open-label

Outcome Measures

Primary Outcomes (1)

• Rate of ready for ECMO weaning at CaRe-ECMO Day 7

  Rate of ready for ECMO weaning will be calculated 7 days after cardiopulmonary rehabilitation delivery

  CaRe-ECMO Day 7

Secondary Outcomes (15)

• Rate of ready for ECMO weaning

  CaRe-ECMO Day 14, 30 and 90

• Rate of ECMO weaning

  CaRe-ECMO Day 7, 14, 30 and 90

• Total length of ready for ECMO weaning

  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

  From date of ECMO initiation until the date of ECMO weaning, assessed up to CaRe-ECMO Day 90

• Rate of mechanical ventilation weaning

  CaRe-ECMO Day 7, 14, 30 and 90

Study Arms (2)

CaRe-ECMO group

ACTIVE COMPARATOR

Patients in the CaRe-ECMO group will be treated with usual care, ECMO therapy, and cardiopulmonary rehabilitation program.

Procedure: Cardiopulmonary rehabilitation; Procedure: Usual care

Control group

PLACEBO COMPARATOR

Usual care and ECMO therapy

Procedure: Usual care

Interventions

Cardiopulmonary rehabilitation PROCEDURE

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.

CaRe-ECMO group

Usual care PROCEDURE

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.

CaRe-ECMO group; Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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

You may not qualify if:

• \) 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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Zheng, M.D.

CONTACT

8617327081766; yu.t.zheng@connect.polyu.hk

Hao Sun, M.D.

CONTACT

8613584017821; Haosun@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending doctor

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 5, 2021
• Study Start: October 15, 2021
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)