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

NCT ID: NCT05225272

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 92 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-09-01
• Study Completion Date: 2027-09-01

Brief Summary

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

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.

Conditions

Disorder; Heart, Functional, Postoperative, Cardiac Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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.

Enhanced Recovery Program for on-pump cardiac surgery

Intervention Type: OTHER

Implementation of a Enhanced Recovery Program for on-pump cardiac surgery patients

Interventions

Enhanced Recovery Program for on-pump cardiac surgery

Implementation of a Enhanced Recovery Program for on-pump cardiac surgery patients

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alex Moore, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier de l'Université de Montréal (CHUM)

Locations

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Countries

Canada

Central Contacts

Alex Moore, MD, FRCPC

Role: CONTACT

alex.moore@umontreal.ca

514-890-8000 ext. 12132

Julie Desroches, PhD

Role: CONTACT

anesthesie.recherche.chum@ssss.gouv.qc.ca

514-890-8000 ext. 24542

Facility Contacts

Cédrick Zaouter, MD, FRCPC

Role: primary

cedrickzaouter@gmail.com

514-890-8000 ext. 12132

Julie Desroches, PhD

Role: backup

anesthesie.recherche.chum@ssss.gouv.qc.ca

514-890-8000 ext. 24542

Other Identifiers

21.320

Identifier Type: -

Identifier Source: org_study_id