Skip to content

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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05225272
Acronym
ERASCs
Enrollment
92
Registered
2022-02-04
Start date
2026-09-01
Completion date
2027-09-01
Last updated
2025-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disorder; Heart, Functional, Postoperative, Cardiac Surgery

Keywords

On-pump cardiac surgery, Enhanced recovery after surgery

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.

Interventions

OTHEREnhanced Recovery Program for on-pump cardiac surgery

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

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Time before patient extubationFrom the end of the surgery to extubation, up to 1 weekTime elapsed between final wound dressing and removal of the endotracheal tube, before and after implementation of the cardiac ERP.

Secondary

MeasureTime frameDescription
Acute pain scores using the Numerical Rating Scale (NRS)8, 16, 24 and 48 hours after surgeryUsing the verbal NRS, where 0 means no pain and 10 worst pain imaginable
Opioid consumption8, 16, 24 and 48 hours after surgeryOpioid consumption converted in intravenous morphine equivalents
Opioid side effects8, 16, 24 and 48 hours after surgeryIncluding nausea, vomiting, sedation and pruritus
Incidence of delirium in the intensive care unit (ICU) using the ICDSC scoreUp to 7 days after surgery or ICU discharge, whichever comes firstDelirium 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.
Postoperative complicationsUp to 7 days after surgeryAny stroke, acute renal failure (using the Kidney Disease Improving Global Outcomes (KDIGO), new-onset atrial fibrillation (more than 30 minutes or requiring cardioversion)
Incidence of reintubationUp to 24 hours after extubationNeed for postoperative endotracheal intubation given the occurrence of respiratory or non-respiratory complication after extubation.
Hospital dischargeAt hospital discharge, an average of one week after surgeryTime and date when the patient is discharged from the hospital
In-hospital mortalityAt hospital discharge, an average of one week after surgeryOccurrence of death during hospitalization
30-day mortalityUp to 30 days after surgeryOccurrence of death during the first 30 days following surgery
Hospital readmissionUp to 30 days after surgeryNeed for readmission following discharge after index surgery
ICU discharge timeAt ICU discharge, an average of one day after surgeryTime and date when the patient is transferred to ward or step-down unit

Countries

Canada

Contacts

Primary ContactAlex Moore, MD, FRCPC
alex.moore@umontreal.ca514-890-8000
Backup ContactJulie Desroches, PhD
anesthesie.recherche.chum@ssss.gouv.qc.ca514-890-8000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026