The Application of Enhanced Recovery After Surgery (ERAS) for Cardiovascular Surgery in the Correction of Complex Congenital Heart Disease

Study Overview
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Brief Summary
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This study is a multicenter, stepwise design, cluster randomized controlled trial. Random sequence is generated by computer, and each center enters the intervention expectation (Phase I) in random order to implement ERAS strategy. If it does not enter the intervention expectation (Phase C) center, clinical diagnosis and treatment will be completed according to the traditional scheme. Among children, patients aged 28 to 6 who underwent cardiac surgery were included in the ERAS strategy intervention plan, which mainly includes preoperative education, preoperative comfort for the patient, preoperative oral sugary beverage, continuous infusion of dexmedetomidine, multimodal analgesia, blood protection strategies, prevention of postoperative nausea and vomiting, intraoperative insulation, early tracheal extubation and intubation, and targeted liquid therapy. The traditional plan group follows the current clinical diagnosis and treatment routine. By comparing the differences in the incidence of major postoperative outcomes (MACE events, major pulmonary complications, and acute kidney injury) between the intervention group and the non intervention group, as well as comparing other adverse events (including but not limited to pneumonia, massive bleeding, postoperative arrhythmia, incision infection, postoperative nausea, vomiting, and delirium), all cause secondary intubation, and all cause secondary surgery between the two groups, and recording hospitalization time, ICU stay time The removal time of tracheal intubation and drainage tube, the pain score during hospitalization, the total amount of opioid drug use (converted to the same dose of morphine), hospitalization expenses, and family satisfaction scores were recorded to explore whether the ERAS regimen can reduce the incidence of major postoperative adverse events, improve patient prognosis, and accelerate postoperative recovery compared to traditional regimens.

Official Title
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The Application of Enhanced Recovery After Surgery (ERAS) for Cardiovascular Surgery in the Correction of Complex Congenital Heart Disease: a Stepped Wedge Cluster Randomized Trial

Conditions
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Complex Congenital Heart Disease, Enhanced Recovery After Surgery

Intervention / Treatment
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* Procedure: ERAS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 28 days to 6 years Patients awaiting elective cardiac surgery with cardiopulmonary bypass (CPB). Exclusion Criteria: The risk adjustment for congenital heart surgery (RACHS) is above class 5 Patients with cardiac assist device, mechanical ventilation or the history of asphyxia Patients with pulmonary disease, including respiratory tract infections and asthma Patients with severe liver or renal dysfunction, including severe acute or chronic renal dysfunction need renal replacement therapy, and acute or chronic liver failure need artificial liver therapy Fetal malformation includes polysplenia syndrome, Asplenia Syndrome, Down syndrome, DiGeoge syndrome, Marfan syndrome, trachea-bronchus stricture, diabetes, nervous functioning disorders, genital system malformations, imperforate anus, and Williams syndrome Current enrollment in another clinical trial Guardian's refusal or low adherence

Ages Eligible for Study
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Minimum Age: 28 Days
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Procedure: ERAS<br>* The primary endpoint is the rate of composite outcomes. The composite outcomes include the major adverse cardiac events (MACE), major postoperative pulmonary complication (PPCs), and acute kidney injury (AKI)<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite outcomes | The composite outcomes include the major adverse cardiac events (MACE), major postoperative pulmonary complication (PPCs), and acute kidney injury (AKI) | during hospitalization, an average of 1 week, assessed up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of hospital stay | From the date of admission until the date of discharging | From the date of admission until the date of discharging, assessed up to 30 days | 
| the duration of intensive care unit (ICU) stay | Time from ICU admission to ICU discharge | Time from ICU admission to ICU discharge, assessed up to 30 days | 
| time to extubation | The time from the end of operation to the removal of tracheal intubation | The time from the end of operation to the removal of tracheal intubation, assessed up to 30 days | 
| time to drainage removal | The time from the end of operation to the removal of drainage tube | The time from the end of operation to the removal of drainage tube, assessed up to 30 days | 
| the rate of other complications | The rate of other complications include delium, pneumonia, pneumothorax, hematorrhea and so on | during hospitalization, an average of 1 week, assessed up to 30 days | 
| the rate of reintubation for any cause | The rate of reintubation for any cause | during hospitalization, an average of 1 week, assessed up to 30 days | 
| cumulative opioid dosage | Total perioperative consumption of opioid analgesics | during hospitalization, an average of 1 week, assessed up to 30 days | 
| overall medical costs | Total cost of patients during hospitalization | during hospitalization, an average of 1 week, assessed up to 30 days | 
| Satisfaction score | A satisfaction rating using a 0-10 number scale (0=unsatisfactory, 10=satisfactory) | the day before discharge, assessed up to 30 days | 
| the cumulative incidence of death from any cause within 30 days and 1 year | the cumulative incidence of death from any cause within 30 days and 1 year | within 30 days and 1 year |