Effectiveness of an Enhanced Recovery After Surgery Protocol in Patients Undergoing On-pump Cardiac Surgery

Study Overview
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Brief Summary
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In 2019, the Enhanced Recovery After Surgery (ERAS) Society published recommendations for perioperative care in cardiac surgery. ERAS recommendations included 22 perioperative interventions that may be part of any cardiac Enhanced Recovery Program (ERP). Since that publication, additional perioperative interventions were reported and may be added to a cardiac ERP. Studies on cardiac ERPs report variable benefits on postoperative recovery including lower pain scores, lower opioid consumption and related side effects, shorter intensive care unit and hospital discharge times. At the Centre Hospitalier de l'Université de Montréal (CHUM), although most care takers are aware of ERAS recommendations for cardiac surgery patients, adherence to these recommendations is heterogeneous and a cardiac ERP was never implemented.

Detailed Description
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Primary objective: Estimate the effect of implementation of an ERP (including the use of a checklist and teaching of caretakers) on the time needed for patient extubation after on-pump cardiac surgery. Secondary objective: Estimate the effect of implementation of a ERP (including the use of a checklist and teaching of caretakers) on the need for reintubation, the need to return to the operating room for hemostasis, on pain scores, opioid consumption and related side effects, on the incidence of postoperative delirium in the intensive care unit, on intensive care unit and hospital discharge times, on postoperative complications (stroke, acute renal failure, postoperative atrial fibrillation), and on in-hospital mortality, 30-day mortality and hospital readmission. The hypothesis of the study is that implementation of an ERP (including the use of a checklist and teaching of caretakers) in patients undergoing on-pump cardiac surgery improves postoperative recovery through shorter extubation time and a reduction of postoperative complications. Design of the study: single center, bidirectional (prospective and retrospective) chronological cohort study. The adherence to ERP interventions will be measured. Prospective data will be collected in eligible patients after implementation of a cardiac ERP and compared retrospectively with eligible patients who had surgery in the year before (but not in the four weeks preceding) implementation of the cardiac ERP. In these patients, prospective data is already collected in a quality of care database in cardiac surgery. The cardiac ERP will be implemented using a checklist designed by cardiac surgeons, anesthesiologists and intensive care specialists. The checklist is based on official ERAS recommendations and other interventions suggested in further studies on ERAS after cardiac surgery. Professionals involved in the perioperative care of cardiac surgery patients will receive specific ERP teachings three weeks and one week before the official implementation of the cardiac ERP. Posters detailing the cardiac ERP will be clearly visible in the cardiac operating rooms and next to the intensive care unit beds to promote adherence.

Official Title
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Evaluation of the Effectiveness of an Enhanced Recovery After Surgery Protocol in Patients Undergoing On-pump Cardiac Surgery

Conditions
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Disorder; Heart, Functional, Postoperative, Cardiac Surgery

Intervention / Treatment
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* Other: Enhanced Recovery Program for on-pump cardiac surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: On-pump cardiac surgery Exclusion Criteria: Left Ventricular Ejection Fraction (LVEF) lower than 50% Glomerular filtration rate lower than 50 mL/min Significant pulmonary hypertension (systolic pulmonary artery pressure higher than 65 mmHg) Presence of Intra-aortic balloon pump therapy before surgery Endocarditis surgery An estimated mortality over 8% based on the EuroSCORE II Patients who already had cardiac surgery in the past.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing on-pump cardiac surgery<br>The investigators aim to conduct a bidirectional (prospective and retrospective) observational, cohort study including on-pump cardiac surgery patients. | Other: Enhanced Recovery Program for on-pump cardiac surgery<br>* Implementation of a Enhanced Recovery Program for on-pump cardiac surgery patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time before patient extubation | Time elapsed between final wound dressing and removal of the endotracheal tube, before and after implementation of the cardiac ERP. | From the end of the surgery to extubation, up to 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of reintubation | Need for postoperative endotracheal intubation given the occurrence of respiratory or non-respiratory complication after extubation. | Up to 24 hours after extubation | 
| Acute pain scores using the Numerical Rating Scale (NRS) | Using the verbal NRS, where 0 means no pain and 10 worst pain imaginable | 8, 16, 24 and 48 hours after surgery | 
| Opioid consumption | Opioid consumption converted in intravenous morphine equivalents | 8, 16, 24 and 48 hours after surgery | 
| Opioid side effects | Including nausea, vomiting, sedation and pruritus | 8, 16, 24 and 48 hours after surgery | 
| Incidence of delirium in the intensive care unit (ICU) using the ICDSC score | Delirium will be assessed every 8 hours during the ICU stay using the Intensive Care Delirium Screening Checklist (ICDSC). A total ICDSC score greater or equal to 4 has a 99% sensitivity for a psychiatric diagnosis of delirium. | Up to 7 days after surgery or ICU discharge, whichever comes first | 
| Postoperative complications | Any stroke, acute renal failure (using the Kidney Disease Improving Global Outcomes (KDIGO), new-onset atrial fibrillation (more than 30 minutes or requiring cardioversion) | Up to 7 days after surgery | 
| ICU discharge time | Time and date when the patient is transferred to ward or step-down unit | At ICU discharge, an average of one day after surgery | 
| Hospital discharge | Time and date when the patient is discharged from the hospital | At hospital discharge, an average of one week after surgery | 
| In-hospital mortality | Occurrence of death during hospitalization | At hospital discharge, an average of one week after surgery | 
| 30-day mortality | Occurrence of death during the first 30 days following surgery | Up to 30 days after surgery | 
| Hospital readmission | Need for readmission following discharge after index surgery | Up to 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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On-pump cardiac surgery, Enhanced recovery after surgery