Enhanced Recovery After Surgery (ERAS) in Coronary Artery Bypass Graft / Off Pump Coronary Artery Bypass (CABG/OPCAB)

ERAS Implementation in Coronary Artery Bypass Surgery

It has been assumed that some elements of the ERAS protocol may contribute to the reduction of complications and improve the satisfaction of patients undergoing coronary artery bypass surgery.

Elements of the ERAS strategy will be tested in this study. The elements that prove to be feasible and have a positive effect on the treatment process will be introduced into everyday clinical practice.

In the next stage of the research, we are planning to investigate whether the introduction of the ERAS strategy has had a long-term positive effect on the quality of life after treatment (a survey 1 month and 6 months after leaving the hospital).

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease; Coronary Stenosis
• Intervention / Treatment: Behavioral: Premedication visit; Dietary supplement: Preoperative period; Drug: Preoperative period; Other: Postoperative period; Other: Intraoperative period; Drug: Intraoperative period; Drug: Intraoperative period; Drug: Intraoperative period; Drug: Intraoperative period; Drug: Intraoperative period

Detailed Description

Evaluation of the impact of implemented elements of the ERAS strategy on the results of surgical treatment of coronary artery disease in the aspect of:

• preoperative preparation (comprehensive information, premedication, hydration),
• haemodynamic stability (discontinuation of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers immediately before surgery), optimal pre- and intraoperative fluid therapy,
• occurrence of respiratory complications (assessment of the duration of mechanical ventilation and passive oxygen therapy),
• demand for painkillers in the postoperative period, after introducing the preemptive strategy,
• incidence of postoperative delirium,
• time to recovery of the normal bowel function (nausea, vomiting),
• possibility of early mobilisation on the first day after surgery,
• patient's satisfaction with treatment assessed on the basis of a survey carried out on the day before leaving the hospital.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Poland
  • Polska
    • Katowice, Polska, Poland, 40-635
      • Upper-Silesian Medical Centre of the Silesian Medical University

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients who meet the inclusion criteria will be eligible for the study. The perioperative period and anaesthesia will be supervised by anaesthesiologists trained to carry out the study. The study group will include 50 patients. The results obtained in the study group will be compared with the results of the control group. The control group will consist of patients treated during the study in accordance with the current standards used in the Department.

Description

Inclusion Criteria:

• CABG/OPCAB (Coronary Artery Bypass Surgery/Off Pump Coronary Bypass Surgery).
• Left ventricular ejection fraction above 35% (EF ≥ 35%).
• The operation was performed in a planned mode.

Exclusion Criteria:

• Haematological diseases and the associated increased risk of bleeding in the early postoperative period. Patients taking anticoagulants until the day of surgery with the exception of aspirin.
• Neurological disorders, stroke with persistent symptoms, dementia.
• Chronic lung disease with hypoxia and the need for regular medication.
• Inability to move independently, disability preventing efficient rehabilitation, prolonged use of painkillers.
• Emergency surgery, reoperation.
• Return to the operating room regardless of the reason (resternotomy).
• Perioperative infarction with circulatory destabilization.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group; Implemented ERAS (Early Recovery After Surgery) elements	Behavioral: Premedication visit; detailed information about surgery, anaesthesia and postoperative period; Dietary supplement: Preoperative period; avoidance of prolonged fasting, intake of fluids with carbohydrates before surgery; Drug: Preoperative period; administration of melatonin 5 mg in the evening and pregabalin 75 mg one hour before entering the operating theatre; Other: Postoperative period; Fluids 1 ml/kg/h; Discontinuation of propofol at the moment of drainage and cardiovascular system stabilization; Fluids administered orally 2 hours after extubation; Early mobilisation; Other: Intraoperative period; deep temperature (necessity to maintain normothermia during the stay in the operating theatre 36 °C. Normothermia should be maintained rather than restored.; Other Names: Normothermia; Drug: Intraoperative period; Pyralgin 1 g i.v. after induction of anaesthesia; in patients allergic to Pyralginum, Perfalgan 1 g i.v.; Drug: Intraoperative period; Ketamine 30 mg i.v. after induction of anaesthesia; Drug: Intraoperative period; Sevoflurane 1.5 MAC higher in patients < 60 years old; Drug: Intraoperative period; Propofol infusion in patients at risk of postoperative vomiting (Apfel ≥ 2 points), sevoflurane administration at the moments of strong stimuli from the operating field; Drug: Intraoperative period; Continuous infusion of balanced multi-electrolyte fluids 1-3 ml/kg/h
Control group; The control group will consist of patients treated during the study in accordance with the current standards used in the Department

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ERAS bundle compliance in the first 72 hours post-op	Number of interventions for the ERAS protocol that are delivered to patient (numeric data e.g. 5 out of 10)	72 hours post operation
Shorter Length Of Hospitalization (LOH)	Total amount of days spent in hospital	up to 4 weeks after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative anxiety	Assessment of patient's emotional status according to Anxiety Likert Scale (consisted of five evenly spaced numbers each anchored to a level of anxiety: 1="not at all anxious," 2="a little anxious," 3="moderately anxious," 4="very anxious," 5="extremely anxious)	on admission to the operating unit
Time to extubation	Time taken until patient extubated post operation (in hours)	0 -72 hours
Assessment of postoperative pain	Pain scores at 6hours, Numeric scale 0 (no pain) - 10 (severe pain)	0-24 hours
Incidence of postoperative nausea and vomiting	To calculate the PONV Impact Scale score, add the numerical responses to questions 1 and 2. A PONV Impact Scale score of ≥5 defines clinically important PONV (Q1. Have you vomited: 0. No; Once; Twice; Three or more times Q2. Have you experienced a feeling of nausea :0. Not at all 1. Sometimes 2. Often or most of the time 3. All of the time)	At moment 0, 3, 6, 12 and 24 hours after extubation
Time to drink	Time until patient first drinks post extubation (in hours)	0-72 hours
Time to eating	Time until patient first eats post extubation (in hours)	0-72 hours
Time to bowel movement	Hours elapsed to event	in hours after extubation, up to 1 week
Incidence of postoperative delirium	Delirium Screening according to Nursing Delirium Screening Scale, Each feature is scored on 0-2 based on severity, with 0=absent, 1=mild, and 2=severe. Positive Nu-DESC is score ≥2, maximum total score is 10	in hours after extubation, up to 72 hours
Postoperative complications	Rate measurement	up to 2 weeks after surgery
Time to mobilisation	First mobilisation with nurse/physiotherapist post-op (in hours)	0-72 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Recovery	This process resulted in the QoR-15 questionnaire ( Part A: How have you been feeling in the last 24 hours; 0-10 0-poor, 10 - excellent; rated areas: breath,food,feeling rested, sleep, hygiene,communicate, getting support, return to work, feeling comfortable, well-being; Part B Have you had any of following in the last 24h: modreate pain, severe pain, nause or vomiting, feeling worried, feeling sad; 10-0, 10 - none of the time, 0 - all of the time	1 and 6 months after operation

Collaborators and Investigators

• Sponsor: Silesian University of Medicine
• Investigators: Study Chair: Ewa Kucewicz-Czech, Upper-Silesian Medical Centre; DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE WITH CARDIAC MONITORING

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2019
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: May 14, 2019
• First Submitted That Met QC Criteria: May 17, 2019
• First Posted (Actual): May 20, 2019

Study Record Updates

• Last Update Posted (Actual): May 20, 2019
• Last Update Submitted That Met QC Criteria: May 17, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Coronary Artery Bypass Surgery/Grafting, ERAS
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Coronary Stenosis
• Other Study ID Numbers: KNW/0022/KB1/26/18

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