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

Chinese Academy of Medical Sciences, Fuwai Hospital

Status

Not yet enrolling

Conditions

Complex Congenital Heart Disease

Enhanced Recovery After Surgery

Treatments

Procedure: ERAS

Study type

Interventional

Funder types

Other

Identifiers

NCT05914103

2023-1969

Details and patient eligibility

About

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.

Enrollment

3,030 estimated patients

Sex

All

Ages

28 days to 6 years old

Volunteers

No Healthy Volunteers

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