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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
3,030
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)
Fuwai hospital
Beijing, Beijing Municipality, China
Fuwai hospital
China, Beijing Municipality, China
composite outcomes
The composite outcomes include the major adverse cardiac events (MACE), major postoperative pulmonary complication (PPCs), and acute kidney injury (AKI)
Time frame: during hospitalization, an average of 1 week, assessed up to 30 days
length of hospital stay
From the date of admission until the date of discharging
Time frame: 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 frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: during hospitalization, an average of 1 week, assessed up to 30 days
cumulative opioid dosage
Total perioperative consumption of opioid analgesics
Time frame: during hospitalization, an average of 1 week, assessed up to 30 days
overall medical costs
Total cost of patients during hospitalization
Time frame: 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)
Time frame: 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
Time frame: within 30 days and 1 year
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