NCT Number: NCT05225272
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Observational
Montreal, Quebec, H2X 0A9, Canada
Cédrick Zaouter, MD, FRCPC
CONTACT
514-890-8000 ext. 12132
François Martin Carrier, MD, PhD
SUB_INVESTIGATOR
Julie Desroches, PhD
CONTACT
514-890-8000 ext. 24542
Louis Mathieu Stevens, MD, PhD
SUB_INVESTIGATOR
Martin Michaud, MD, PhD
SUB_INVESTIGATOR
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Implementation of a Enhanced Recovery Program for on-pump cardiac surgery patients
Time frame: From the end of the surgery to extubation, up to 1 week
Time elapsed between final wound dressing and removal of the endotracheal tube, before and after implementation of the cardiac ERP.
Time frame: Up to 24 hours after extubation
Need for postoperative endotracheal intubation given the occurrence of respiratory or non-respiratory complication after extubation.
Time frame: 8, 16, 24 and 48 hours after surgery
Using the verbal NRS, where 0 means "no pain" and 10 "worst pain imaginable"
Time frame: 8, 16, 24 and 48 hours after surgery
Opioid consumption converted in intravenous morphine equivalents
Time frame: 8, 16, 24 and 48 hours after surgery
Including nausea, vomiting, sedation and pruritus
Time frame: Up to 7 days after surgery or ICU discharge, whichever comes first
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.
Time frame: Up to 7 days after surgery
Any stroke, acute renal failure (using the Kidney Disease Improving Global Outcomes (KDIGO), new-onset atrial fibrillation (more than 30 minutes or requiring cardioversion)
Time frame: At ICU discharge, an average of one day after surgery
Time and date when the patient is transferred to ward or step-down unit
Time frame: At hospital discharge, an average of one week after surgery
Time and date when the patient is discharged from the hospital
Time frame: At hospital discharge, an average of one week after surgery
Occurrence of death during hospitalization
Time frame: Up to 30 days after surgery
Occurrence of death during the first 30 days following surgery
Time frame: Up to 30 days after surgery
Need for readmission following discharge after index surgery
Contact information is provided by the study sponsor or research team.
Alex Moore, MD, FRCPC
CONTACT
514-890-8000 ext. 12132
Julie Desroches, PhD
CONTACT
514-890-8000 ext. 24542
Centre hospitalier de l'Université de Montréal (CHUM)
Other
Evaluation of the Effectiveness of an Enhanced Recovery After Surgery Protocol in Patients Undergoing On-pump Cardiac Surgery
Acronym: ERASCs
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