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

Disorder; Heart, Functional, Postoperative, Cardiac Surgery Clinical Trial

— ERASCs  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05225272
• Other study ID #: 21.320
• Status: Not yet recruiting
• Start date: December 1, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: February 2024
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: Alex Moore, MD, FRCPC
• Phone: 514-890-8000
• Email: alex.moore[@]umontreal.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 92
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2025
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disorder; Heart, Functional, Postoperative, Cardiac Surgery

Intervention

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

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal (CHUM)	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Opioid consumption	Opioid consumption converted in intravenous morphine equivalents	8, 16, 24 and 48 hours after surgery
Secondary	Opioid side effects	Including nausea, vomiting, sedation and pruritus	8, 16, 24 and 48 hours after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	Hospital discharge	Time and date when the patient is discharged from the hospital	At hospital discharge, an average of one week after surgery
Secondary	In-hospital mortality	Occurrence of death during hospitalization	At hospital discharge, an average of one week after surgery
Secondary	30-day mortality	Occurrence of death during the first 30 days following surgery	Up to 30 days after surgery
Secondary	Hospital readmission	Need for readmission following discharge after index surgery	Up to 30 days after surgery