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

The Application of Enhanced Recovery After Surgery (ERAS) for Cardiovascular Surgery in Adult: a Stepped Wedge Cluster Randomized Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiac Surgery; Enhanced Recovery After Surgery
• Intervention / Treatment: Procedure: ERAS

• Study Type: Interventional
• Enrollment (Estimated): 3600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yan/Principle investigator; Phone Number: 13641158173; Email: yanfuxia@sina.com

Study Locations

• China
  • Beijing
    • China, Beijing, China, 100037
      • Fuwai Hospital
      • Contact: Fuxia Yan/Principal investigator; Phone Number: 13641158173; Email: yanfuxia@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Intervention group	Procedure: ERAS; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yan Fuxia

Study record dates

Study Major Dates

• Study Start (Estimated): October 11, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: May 15, 2023
• First Submitted That Met QC Criteria: June 12, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2023--1968

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No