Cardiac Surgery, Enhanced Recovery After Surgery
Conditions
Brief summary
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.
Interventions
PROCEDUREERAS
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.
Sponsors
Yan Fuxia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite outcomes | during hospitalization, an average of 1 week, assessed up to 30 days | The composite outcomes include the major adverse cardiac and cerebrovascular events (MACCE), major postoperative pulmonary complication (PPCs), and acute kidney injury (AKI). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| length of hospital stay | From the date of admission until the date of discharging, assessed up to 30 days | From the date of admission until the date of discharging |
| the duration of intensive care unit (ICU) stay | Time from ICU admission to ICU discharge, assessed up to 30 days | Time from ICU admission to ICU discharge |
| time to extubation | The time from the end of operation to the removal of tracheal intubation, assessed up to 30 days | The time from the end of operation to the removal of tracheal intubation |
| time to drainage removal | The time from the end of operation to the removal of drainage tube, assessed up to 30 days | The time from the end of operation to the removal of drainage tube |
| the rate of other complications | during hospitalization, an average of 1 week, assessed up to 30 days | The rate of other complications include delium, pneumonia, pneumothorax, hematorrhea and so on |
| the quality of recovery score (QoR)-15 after surgery | At 24 hour after surgery | — |
| cumulative opioid dosage | during hospitalization, an average of 1 week, assessed up to 30 days | Total perioperative consumption of opioid analgesics |
| overall medical costs | during hospitalization, an average of 1 week, assessed up to 30 days | Total cost of patients during hospitalization |
| satisfaction score | the day before discharge, assessed up to 30 days | A satisfaction rating using a 0-10 number scale (0=unsatisfactory, 10=satisfactory) |
| the outcomes of long-term prognosis by telephone follow-up | within 30 days, 3 months, and 1 year | the outcomes of prognosis |
| the rate of reintubation for any cause | during hospitalization, an average of 1 week, assessed up to 30 days | The rate of reintubation for any cause |
Countries
China
Contacts
Primary ContactYan/Principle investigator
Outcome results
None listed