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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Disorder; Heart, Functional, Postoperative, Cardiac Surgery
• Intervention / Treatment: Other: Enhanced Recovery Program for on-pump cardiac surgery

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 92

Contacts and Locations

• Study Contact: Name: Alex Moore, MD, FRCPC; Phone Number: 12132 514-890-8000; Email: alex.moore@umontreal.ca
• Study Contact Backup: Name: Julie Desroches, PhD; Phone Number: 24542 514-890-8000; Email: anesthesie.recherche.chum@ssss.gouv.qc.ca

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2X 0A9
      • Centre Hospitalier de l'Université de Montréal (CHUM)
      • Contact: Cédrick Zaouter, MD, FRCPC; Phone Number: 12132 514-890-8000; Email: cedrickzaouter@gmail.com
      • Sub-Investigator: François Martin Carrier, MD, PhD
      • Sub-Investigator: Martin Michaud, MD, PhD
      • Sub-Investigator: Louis Mathieu Stevens, MD, PhD
      • Contact: Julie Desroches, PhD; Phone Number: 24542 514-890-8000; Email: anesthesie.recherche.chum@ssss.gouv.qc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

The investigators aim to conduct a bidirectional cohort study including on-pump cardiac surgery patients. This study will take place at the Centre Hospitalier de l'Université de Montréal (CHUM).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing on-pump cardiac surgery; 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; Implementation of a Enhanced Recovery Program for on-pump cardiac surgery patients

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Investigators: Principal Investigator: Alex Moore, MD, FRCPC, Centre Hospitalier de l'Université de Montréal (CHUM)

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: January 26, 2022
• First Submitted That Met QC Criteria: February 1, 2022
• First Posted (Actual): February 4, 2022

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Enhanced recovery after surgery; On-pump cardiac surgery
• Other Study ID Numbers: 21.320

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