The Application of Enhanced Recovery After Surgery (ERAS) for Cardiovascular Surgery in Adult

Study Overview
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Brief Summary
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Among adults, patients undergoing elective extracorporeal circulation for cardiac surgery are included in the ERAS strategy intervention plan, which mainly includes preoperative education, preoperative oral intake of multidimensional carbohydrate beverages, multimodal analgesia, blood protection strategies, correction of perioperative hypoalbuminemia, early removal of tracheal intubation, maintenance of blood sugar at reasonable levels, 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 (MACCE 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, as well as the pain score during hospitalization and the total amount of opioid drug use (converted to equivalent dose morphine), hospitalization cost, postoperative recovery quality QoR15 scale score, and patient satisfaction score, 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 Adult: a Stepped Wedge Cluster Randomized Trial

Conditions
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Cardiac Surgery, 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 18 to 80 years Patients awaiting elective cardiac surgery with cardiopulmonary bypass (CPB) Exclusion Criteria: American Society of Anesthesiologists (ASA) class is above class V Patients with cardiac assist device or mechanical ventilation The ejection fraction of patients is less than 30% Patients with morbid obesity Patients with severe obstructive sleep apnea-hypopnea syndrome (OSAHS) Patients with severe pulmonary disease, including severe chronic obstructive pulmonary disease (COPD) or respiratory failure 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 Patients with long-term opioid or sedative utilization Patients with a history of alcohol or cigarette abuse Patients with long-term hormone therapy An international normalized ratio > 2.0 Patients with severe malnutrition Mental or legal disability Current enrollment in another clinical trial Patients' refusal or low adherence

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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 group<br> | Procedure: ERAS<br>* Among adults, patients undergoing elective extracorporeal circulation for cardiac surgery are included in the ERAS strategy intervention plan, which mainly includes preoperative education, preoperative oral intake of multidimensional carbohydrate beverages, multimodal analgesia, blood protection strategies, correction of perioperative hypoalbuminemia, early removal of tracheal intubation, maintenance of blood sugar at reasonable levels, and targeted liquid therapy.<br>|
| No Intervention: Control group<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 and cerebrovascular events (MACCE), 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 |
| --- | --- | --- |
| the quality of recovery score (QoR)-15 after surgery |  | At 24 hour after surgery | 
| 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 outcomes of long-term prognosis by telephone follow-up | the outcomes of prognosis | within 30 days, 3 months, and 1 year |