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

NCT03956420 | Unknown

• 1 other identifier: KNW/0022/KB1/26/18
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Coronary Artery Disease; Coronary Stenosis

Keywords

Coronary Artery Bypass Surgery/Grafting, ERAS

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Preoperative anxiety

  on admission to the operating unit

• Time to extubation

  0 -72 hours

• Assessment of postoperative pain

  0-24 hours

• Incidence of postoperative nausea and vomiting

  At moment 0, 3, 6, 12 and 24 hours after extubation

• Time to drink

  0-72 hours

Other Outcomes (1)

• Quality of Recovery

  1 and 6 months after operation

Study Arms (2)

Study group

Implemented ERAS (Early Recovery After Surgery) elements

Behavioral: Premedication visit; Dietary Supplement: Preoperative period; Drug: Preoperative period; Other: Postoperative period; Other: Intraoperative period; Drug: Intraoperative period

Control group

The control group will consist of patients treated during the study in accordance with the current standards used in the Department

Interventions

Premedication visit BEHAVIORAL

detailed information about surgery, anaesthesia and postoperative period

Study group

Preoperative period DIETARY_SUPPLEMENT

avoidance of prolonged fasting, intake of fluids with carbohydrates before surgery

Study group

Postoperative period OTHER

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

Study group

Intraoperative period OTHER

deep temperature (necessity to maintain normothermia during the stay in the operating theatre 36 °C. Normothermia should be maintained rather than restored.

Also known as: Normothermia

Study group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Silesian University of Medicine: lead

Study Sites (1)

Upper-Silesian Medical Centre of the Silesian Medical University

Katowice, Polska, 40-635, Poland

Location

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis

Interventions

Preoperative Period; Postoperative Period; Intraoperative Period

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Perioperative Period; Surgical Procedures, Operative; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ewa Kucewicz-Czech

  Upper-Silesian Medical Centre; DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE WITH CARDIAC MONITORING

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Head of Unit

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 20, 2019
• Study Start: May 3, 2019
• Primary Completion: January 1, 2020
• Study Completion: May 1, 2021
• Last Updated: May 20, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)