CaRe-ECMO Program on ECMO Weaning

Critical Illness Clinical Trial

— CaRe-ECMO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05035797
• Other study ID #: CaRe-ECMO
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2022
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Yu Zheng, M.D.
• Phone: 8617327081766
• Email: yu.t.zheng[@]connect.polyu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 366
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of ready for ECMO weaning	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
Secondary	Rate of ECMO weaning	Rate of ECMO weaning will be calculated according to date of ECMO weaning fulfilled	CaRe-ECMO Day 7, 14, 30 and 90
Secondary	Total length of ready for ECMO weaning	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
Secondary	Total length of ECMO weaning	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
Secondary	Rate of mechanical ventilation weaning	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
Secondary	Total length of mechanical ventilation	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
Secondary	All-cause mortality	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
Secondary	Major complications	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
Secondary	Diaphragmatic thickness and mobility	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
Secondary	ECMO Unit length of stay (LOS)	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
Secondary	Total hospital length of stay	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
Secondary	Total cost for hospitalization	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
Secondary	Cerebral performance category (CPC) index	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
Secondary	Activity of daily living (ADL)	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
Secondary	Health related quality of life (HRQoL)	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