Can Cardiopulmonary Rehabilitation Facilitate Weaning of Extracorporeal Membrane Oxygenation (CaRe-ECMO)? Study Protocol for a Prospective Multidisciplinary Randomized Controlled Trial.

Yu Zheng,Baoquan Li,Xufeng Chen,Shenrui Wang,Yongxia Gao,Xintong Zhang,Dijia Pan,Zhongman Zhang,Ying Chen,Wei Li,Huazhong Zhang,Gang Zhang,Lu Wang,Jinru Lv,Deliang Hu,Feng Sun,Jinsong Zhang ,Huiling Sun ,Yong Mei ,Xiao Lü

doi:10.3389/fcvm.2021.779695

Abstract

Background: Mortality of patients suffering from critical illness has been dramatically improved with advanced technological development of extracorporeal membrane oxygenation (ECMO) therapy. However, the majority of ECMO-supported patients failed to wean from ECMO therapy. 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 role 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 ECMO weaning in ECMO-supported patients (CaRe-ECMO).Methods: The CaRe-ECMO trial is a randomized controlled, parallel group, clinical trial. This trial will be performed in a minimum number of 366 ECMO-supported eligible patients. Patients will be randomly assigned to either: (1) the CaRe-ECMO group, which will be treated with usual care including pharmacotherapy, non-pharmacotherapy, and specific nursing for ECMO therapy and the CaRe-ECMO program; or (2) the control group, which will receive usual care only. The CaRe-ECMO program consists of protocolized positioning, passive range of motion (PROM) training, neuromuscular electrical stimulation (NMES), surface electrical phrenic nerve stimulation (SEPNS), and pulmonary rehabilitation. The primary outcome of the CaRe-ECMO trial is the rate of ready for ECMO weaning at CaRe-ECMO day 7 (refers to 7 days after the CaRe-ECMO program initiation). Secondary outcomes include rate of ECMO and mechanical ventilation weaning, total length in day of ready for ECMO weaning, ECMO weaning and mechanical ventilation, all-cause mortality, rate of major post-ECMO complications, ECMO unit length of stay (LOS) and hospital LOS, total cost for hospitalization, cerebral performance category (CPC), activities of daily living (ADL), and health-related quality of life (HRQoL).Discussion: The CaRe-ECMO is designed to answer the question “whether cardiopulmonary rehabilitation can facilitate weaning of ECMO (CaRe-ECMO).” Should the implementation of the CaRe-ECMO program result in superior primary and secondary outcomes as compared to the controls, specifically the add-on effects of cardiopulmonary rehabilitation to the routine ECMO practice for facilitating successful weaning, the CaRe-ECMO trial will offer an innovative treatment option for ECMO-supported patients and meaningfully impact on the standard care in ECMO therapy.Clinical Trial Registration: ClinicalTrials.gov, identifier: NCT05035797.

Highlights

Recent improvements in technology have created extra chances for lifesaving, i.e., using extracorporeal membrane oxygenation (ECMO) as a bridge to win over time for the body and medical strategies struggling with critical illness [1]
Hemodynamic and cardiac functional assessment: If MAP > 70 mmHg and PPD > 30 mmHg for 24 h, the heart rate increases over 20% of the baseline following the reduction of ECMO flow, Vasoactive-inotrope score (VIS) of 70%, with improved function of other damaged organs, move to the step
We considered the rate of ready for ECMO weaning being conservatively 50% higher in the CaRe-ECMO group than in the control group at CaRe-ECMO day 7 as a clinically meaningful effect, implying a hazard ratio (HR) of 0.5

Summary

Introduction

Recent improvements in technology have created extra chances for lifesaving, i.e., using extracorporeal membrane oxygenation (ECMO) as a bridge to win over time for the body and medical strategies struggling with critical illness [1]. Pulmonary, or cardiopulmonary failure who have failed conventional treatment appeared to benefit from ECMO therapy [2] This population is often exposed to prolonged immobilization, which may lead to multiple complications and impaired physical function [3]. Shortening the sedative course and managing issues such as intensive care unit (ICU)-acquired weakness and critical illness-induced cardiopulmonary function impairment should take priority, as this can greatly impact the post-ECMO prognosis. In this context, attention toward enhancing ICU recovery, reducing complications, and improving functional prognosis has started to be shifted to ECMOsupported patients [4]. The purpose of this study is to investigate the effectiveness of cardiopulmonary rehabilitation on rate of ready for ECMO weaning in ECMO-supported patients (CaRe-ECMO)

Objectives

Methods

Findings

Conclusion