EFFECTS OF ERAS PROTOCOLS ON PATIENT OUTCOMES IN CARDIOVASCULAR SURGERY

THE EFFECTS OF ERAS PROTOCOLS ON PATIENT OUTCOMES IN CARDIOVASCULAR SURGERY

A randomized controlled experimental study has been conducted to determine the effects of Enhanced Recovery After Surgery (ERAS) protocols on patient outcomes in the Cardiovascular Surgery Clinic.

Study Overview

• Status: Completed
• Conditions: ERAS Programmes
• Intervention / Treatment: Behavioral: Enhanced Recovery After Surgery (ERAS) Protocol

Detailed Description

This randomized controlled trial was conducted to evaluate the effects of an Enhanced Recovery After Surgery (ERAS) protocol on postoperative recovery and patient outcomes in patients undergoing elective coronary artery bypass grafting (CABG) surgery. The study was conducted in the Cardiovascular Surgery Clinic of Bolu Abant İzzet Baysal University İzzet Baysal Training and Research Hospital. A total of 50 patients who met the eligibility criteria were included in the study and randomly assigned to either the ERAS group (n=25) or the control group (n=25). Patients in the ERAS group received a comprehensive perioperative care program based on ERAS principles. The ERAS program included preoperative oral carbohydrate loading, multimodal analgesia, prevention of postoperative nausea and vomiting, early extubation, respiratory exercises, coughing exercises, early mobilization, and other evidence-based perioperative interventions. Patients in the control group received routine perioperative care according to standard clinical practice. The primary outcomes included quality of recovery and postoperative clinical outcomes. Quality of recovery was assessed using the Quality of Recovery-40 (QoR-40) questionnaire. Secondary outcomes included anxiety, pain intensity, nutritional risk, postoperative delirium, and cardiovascular surgery-related symptoms. Clinical recovery outcomes included time to extubation, duration of intensive care unit stay, duration of surgical drain use, time to urinary catheter removal, time to first bowel movement, time to first oral intake, and length of hospital stay. Patients were evaluated at multiple time points throughout the postoperative recovery process. Assessments were performed during the intensive care unit stay, after transfer to the surgical ward, at hospital discharge, and at one week and one month after discharge. These repeated assessments were used to evaluate changes in quality of recovery, anxiety, pain, cardiovascular surgery-related symptoms, and other patient outcomes over time. The study aimed to determine whether implementation of a comprehensive ERAS protocol could improve quality of recovery, reduce postoperative symptoms and anxiety, facilitate earlier recovery, shorten intensive care unit and hospital stays, and contribute to improved clinical outcomes in patients undergoing cardiovascular surgery.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Bolu, Turkey (Türkiye)
    • Bolu Abant İzzet Baysal University İzzet Baysal Training and Research Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Being admitted for their first planned coronary artery bypass graft (CABG) surgery;
• Undergoing off-pump coronary artery bypass (OPCAB) surgery without the use of a cardiopulmonary bypass machine;
• Not undergoing any additional surgical procedure during CABG surgery;
• Having no abnormalities in preoperative laboratory parameters, including hemoglobin, albumin, and electrolytes;
• Having no cognitive impairment;
• Having no psychological or mental disorder;
• Being able to speak Turkish and communicate effectively;
• Being at least literate;
• Being 18 years of age or older;
• Being reachable by telephone during the follow-up period; and
• Providing informed consent to participate in the study.

Exclusion Criteria:

• Having previously undergone CABG surgery;
• Undergoing CABG surgery using cardiopulmonary bypass with the heart arrested;
• Undergoing any additional surgical procedure during CABG surgery;
• Having electrolyte abnormalities in preoperative laboratory parameters;
• Having cognitive impairment;
• Having a psychological or mental disorder;
• Being unable to speak Turkish, communicate effectively, or provide consent to participate in the study;
• Being unable to read and write;
• Being younger than 18 years of age;
• Being unreachable by telephone during the follow-up period;
• Withdrawing from the study after initially agreeing to participate;
• Undergoing any surgical operation after hospital admission; or
• Dying during the study intervention or follow-up period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ENHANCED RECOVERY AFTER SURGERY (ERAS) GROUP; Patients in the ERAS group received a multimodal enhanced recovery program covering the preoperative, intraoperative, and postoperative periods. Interventions included patient education and counseling, nutritional assessment and support when indicated, preoperative oral carbohydrate loading, appropriate fasting, and avoidance of mechanical bowel preparation. Intraoperative interventions included multimodal anesthesia, lung-protective ventilation, maintenance of normothermia, antimicrobial prophylaxis, blood conservation, and minimization of surgical drains. Postoperative care included early extubation, respiratory physiotherapy, incentive spirometry, coughing and leg exercises, early mobilization and oral intake, multimodal analgesia, thromboprophylaxis, glycemic control, wound care, delirium screening, and early removal of chest tubes and urinary catheters when clinically appropriate. Quality of recovery, anxiety, pain, and cardiovascular surgery-related symptoms were assessed during	Behavioral: Enhanced Recovery After Surgery (ERAS) Protocol; A comprehensive 31-factor Enhanced Recovery After Surgery (ERAS) program was implemented throughout the perioperative period in patients undergoing elective coronary artery bypass grafting (CABG) surgery. The program included patient education and counseling, nutritional assessment, preoperative oral carbohydrate loading, appropriate fasting, avoidance of mechanical bowel preparation, multimodal anesthesia and analgesia, lung-protective ventilation, normothermia, antimicrobial prophylaxis, blood conservation, prevention of postoperative nausea and vomiting, early extubation, respiratory physiotherapy, incentive spirometry, coughing and leg exercises, early mobilization and oral intake, thromboprophylaxis, glycemic control, systematic delirium screening, wound care, and early removal of chest tubes and urinary catheters when clinically appropriate. Quality of recovery, anxiety, pain, and cardiovascular surgery-related symptoms were assessed at predefined postoperative time points.
No Intervention: CONTROL GROUP; Patients in the control group received routine perioperative care according to standard clinical practice. No specific Enhanced Recovery After Surgery (ERAS) protocol was applied. Patients received standard preoperative, intraoperative, and postoperative care, including routine monitoring, pain management, respiratory care, mobilization, nutritional management, and other clinical interventions as indicated by the treating healthcare team. Patient outcomes were assessed at the same time points as in the ERAS group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Recovery-40 (QoR-40) Score	The scale is a 5-point Likert-type scale, and the total score ranges from 40 to 200 based on the sum of all items. A higher total score indicates that the patients' emotional and physical well-being is at the expected and favorable level following surgery, whereas a lower score indicates that their well-being has been adversely affected. With a Cronbach's alpha value of 0.936, the questionnaire is a valid and reliable instrument for assessing recovery following	one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac Surgery-Related Symptom Score	The inventory is unidimensional and consists of 35 items. It is a Likert-type instrument, with each item scored from 0 to 4. The total score ranges from 0 to 140, with higher scores indicating greater symptom severity. The inventory has a total Cronbach's alpha coefficient of 0.961, and the total item correlations for all items are positive.	one month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
State-Trait Anxiety Inventory Score	The State-Trait Anxiety Inventory (STAI) was developed to assess individuals' state and trait anxiety levels separately. The scale consists of two sections and 40 items. The first section, the State Anxiety Inventory, assesses how the individual feels at a particular moment, whereas the second section, the Trait Anxiety Inventory, assesses the individual's general feelings and anxiety tendency. Higher total anxiety scores indicate higher levels of anxiety. The scale has a Cronbach's alpha coefficient of 0.76.	1 month
Postoperative Delirium	The scale assesses eight domains: attention deficit, altered level of consciousness, hallucinations, psychosis, delusions, disorientation, psychomotor retardation or agitation, inappropriate affect or speech, sleep-wake cycle disturbance, and fluctuating course of symptoms. Negative findings are scored as 0, while positive findings are scored as 1. Patients with a total score of 4 or higher are considered to have delirium	One month

Collaborators and Investigators

• Sponsor: Karabuk University
• Investigators: Principal Investigator: Aynur Ülkü, Karabuk Universty

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2024
• Primary Completion (Actual): October 30, 2024
• Study Completion (Actual): May 30, 2025

Study Registration Dates

• First Submitted: September 8, 2026
• First Submitted That Met QC Criteria: September 8, 2026
• First Posted (Actual): September 14, 2026

Study Record Updates

• Last Update Posted (Actual): September 14, 2026
• Last Update Submitted That Met QC Criteria: September 8, 2026
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Postoperative Pain; Anxiety; Cardiac Surgery; ERAS; Symptoms
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Mental Disorders; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Anxiety Disorders; Health Care Quality, Access, and Evaluation; Therapeutics; Surgical Procedures, Operative; Health Care Evaluation Mechanisms; Quality of Health Care; Epidemiologic Study Characteristics; Perioperative Care; Enhanced Recovery After Surgery; Clinical Protocols
• Other Study ID Numbers: KarabukU-AUlku-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant-level data will not be shared publicly due to patient privacy and confidentiality requirements. However, the aggregated results of the study will be reported and made available through scientific publication. No personally identifiable patient information will be included in the published results.

Drug and device information, study documents

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