An interventional study of Cardiopulmonary rehabilitation and Usual care in Critical Illness, sponsored by The First Affiliated Hospital with Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-31.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Not applicable, Interventional, and Treatment
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).
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.
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This study's planned enrollment of 366 is above the median of 90 across 979 interventional studies indexed under Critical Illness.
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Exclusion Criteria:
Patients in the CaRe-ECMO group will be treated with usual care, ECMO therapy, and cardiopulmonary rehabilitation program.
Procedure: Cardiopulmonary rehabilitation · Procedure: Usual care
Usual care and ECMO therapy
Procedure: Usual care
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.
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.
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
Time frame: CaRe-ECMO Day 7
Rate of ready for ECMO weaning
Rate of ready for ECMO weaning will be calculated 14, 30 and 90 days after cardiopulmonary rehabilitation delivery
Time frame: CaRe-ECMO Day 14, 30 and 90
Rate of ECMO weaning
Rate of ECMO weaning will be calculated according to date of ECMO weaning fulfilled
Time frame: CaRe-ECMO Day 7, 14, 30 and 90
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
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 ECMO weaning
Total length of ECMO weaning refers to exact length in day for patients treated with ECMO therapy
Time frame: From date of ECMO initiation until the date of ECMO weaning, assessed up to CaRe-ECMO Day 90
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
Time frame: CaRe-ECMO Day 7, 14, 30 and 90
Total length of mechanical ventilation
Total length of mechanical ventilation refers to exact length in day for patients treated with mechanical ventilation
Time frame: From date of mechanical ventilation initiation until the date of mechanical ventilation weaning, assessed up to CaRe-ECMO Day 90
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
Time frame: CaRe-ECMO Day 7, 14, 30 and 90
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
Time frame: CaRe-ECMO Day 7, 14, 30 and 90
Diaphragmatic thickness and mobility
Diaphragmatic thickness and mobility refer to ultrasound guided evaluation of diaphragmatic thickness and mobility under M mode
Time frame: Every three days, assessed up to CaRe-ECMO Day 90
ECMO Unit length of stay (LOS)
ECMO Unit length of stay (LOS) accounts for length in day for patients' stay in the ECMO Unit
Time frame: Discharge day (discharge from ECMO Unit), assessed up to CaRe-ECMO Day 90
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
Time frame: Discharge day (discharge from hospital), assessed up to CaRe-ECMO Day 90
Total cost for hospitalization
Total cost for hospitalization will be calculated by addition of the cost of all units and departments admission
Time frame: Discharge day (discharge from hospital), assessed up to CaRe-ECMO Day 90
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
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)
Activity of daily living (ADL) will be evaluated, for those successfully weaning of ECMO, with Katz Index
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)
Health related quality of life (HRQoL) will be measured, for those successfully weaning of ECMO, with SF-12
Time frame: CaRe-ECMO Day 7, 14, 30, 90 and discharge day (discharge from ECMO Unit), assessed up to CaRe-ECMO Day 90
Plan to share: No
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