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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).

Clinical Trial 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 Design

Related Conditions & MeSH terms

NCT number NCT05035797
Study type Interventional
Source The First Affiliated Hospital with Nanjing Medical University
Contact Yu Zheng, M.D.
Phone 8617327081766
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date September 15, 2021
Completion date December 31, 2025

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