Clinical trial NCT05035797: CaRe-ECMO Program on ECMO Weaning
Official title: Impact of Cardiopulmonary Rehabilitation on Weaning of Extracorporeal Membrane Oxygenation (CaRe-ECMO): a Prospective Multidisciplinary Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Critical Illness
Keywords: Extracorporeal Membrane Oxygenation
Cardiopulmonary Rehabilitation
Weaning
Multidisciplinary
Randomized controlled trial
Open-label
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 366
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of ready for ECMO weaning at CaRe-ECMO Day 7
timeFrame: CaRe-ECMO Day 7
Secondary outcomes:
measure: Rate of ready for ECMO weaning
timeFrame: CaRe-ECMO Day 14, 30 and 90
measure: Rate of ECMO weaning
timeFrame: CaRe-ECMO Day 7, 14, 30 and 90
measure: Total length of ready for ECMO weaning
timeFrame: From date of ECMO initiation until the date of ready for ECMO weaning, assessed up to CaRe-ECMO Day 90
measure: Total length of ECMO weaning
timeFrame: From date of ECMO initiation until the date of ECMO weaning, assessed up to CaRe-ECMO Day 90
measure: Rate of mechanical ventilation weaning
timeFrame: CaRe-ECMO Day 7, 14, 30 and 90
measure: Total length of mechanical ventilation
timeFrame: From date of mechanical ventilation initiation until the date of mechanical ventilation weaning, assessed up to CaRe-ECMO Day 90
measure: All-cause mortality
timeFrame: CaRe-ECMO Day 7, 14, 30 and 90
measure: Major complications
timeFrame: CaRe-ECMO Day 7, 14, 30 and 90
measure: Diaphragmatic thickness and mobility
timeFrame: Every three days, assessed up to CaRe-ECMO Day 90
measure: ECMO Unit length of stay (LOS)
timeFrame: Discharge day (discharge from ECMO Unit), assessed up to CaRe-ECMO Day 90
measure: Total hospital length of stay
timeFrame: Discharge day (discharge from hospital), assessed up to CaRe-ECMO Day 90
measure: Total cost for hospitalization
timeFrame: Discharge day (discharge from hospital), assessed up to CaRe-ECMO Day 90
measure: Cerebral performance category (CPC) index
timeFrame: CaRe-ECMO Day 7, 14, 30, 90 and discharge day (discharge from ECMO Unit), assessed up to CaRe-ECMO Day 90
measure: Activity of daily living (ADL)
timeFrame: CaRe-ECMO Day 7, 14, 30, 90 and discharge day (discharge from ECMO Unit), assessed up to CaRe-ECMO Day 90
measure: Health related quality of life (HRQoL)
timeFrame: CaRe-ECMO Day 7, 14, 30, 90 and discharge day (discharge from ECMO Unit), assessed up to CaRe-ECMO Day 90
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Xiao Lu, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Jingsong Zhang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Xufeng Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: