Clinical trial NCT03956420: Enhanced Recovery After Surgery (ERAS) in Coronary Artery Bypass Graft / Off Pump Coronary Artery Bypass (CABG/OPCAB)
Official title: ERAS Implementation in Coronary Artery Bypass Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Coronary Stenosis
Keywords: Coronary Artery Bypass Surgery/Grafting, ERAS
Lead sponsor: Silesian University of Medicine
Sponsor class: OTHER
First posted: 2019-05-20
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: ERAS bundle compliance in the first 72 hours post-op
timeFrame: 72 hours post operation
measure: Shorter Length Of Hospitalization (LOH)
timeFrame: up to 4 weeks after operation
Secondary outcomes:
measure: Preoperative anxiety
timeFrame: on admission to the operating unit
measure: Time to extubation
timeFrame: 0 -72 hours
measure: Assessment of postoperative pain
timeFrame: 0-24 hours
measure: Incidence of postoperative nausea and vomiting
timeFrame: At moment 0, 3, 6, 12 and 24 hours after extubation
measure: Time to drink
timeFrame: 0-72 hours
measure: Time to eating
timeFrame: 0-72 hours
measure: Time to bowel movement
timeFrame: in hours after extubation, up to 1 week
measure: Incidence of postoperative delirium
timeFrame: in hours after extubation, up to 72 hours
measure: Postoperative complications
timeFrame: up to 2 weeks after surgery
measure: Time to mobilisation
timeFrame: 0-72 hours
Other outcomes:
measure: Quality of Recovery
timeFrame: 1 and 6 months after operation
Locations:
city: Katowice
country: Poland
facility: Upper-Silesian Medical Centre of the Silesian Medical University
state: Polska
Study officials:
affiliation: Upper-Silesian Medical Centre; DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE WITH CARDIAC MONITORING
name: Ewa Kucewicz-Czech
role: STUDY_CHAIR
References: