Effectiveness of an Enhanced Recovery After Surgery Protocol in Patients Undergoing On-pump Cardiac Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Enhanced Recovery Program for on-pump cardiac surgery.
- Who it may be relevant to
- Registry conditions: Disorder; Heart, Functional, Postoperative, Cardiac Surgery. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Effectiveness of an Enhanced Recovery After Surgery Protocol in Patients Undergoing On-pump Cardiac Surgery
Overview
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
- Other Enhanced Recovery Program for on-pump cardiac surgery
Implementation of a Enhanced Recovery Program for on-pump cardiac surgery patients
Primary outcome measures
- Time before patient extubation [Time frame: From the end of the surgery to extubation, up to 1 week]
Secondary outcome measures (11)
- Incidence of reintubation [Time frame: Up to 24 hours after extubation]
- Acute pain scores using the Numerical Rating Scale (NRS) [Time frame: 8, 16, 24 and 48 hours after surgery]
- Opioid consumption [Time frame: 8, 16, 24 and 48 hours after surgery]
- Opioid side effects [Time frame: 8, 16, 24 and 48 hours after surgery]
- Incidence of delirium in the intensive care unit (ICU) using the ICDSC score [Time frame: Up to 7 days after surgery or ICU discharge, whichever comes first]
- Postoperative complications [Time frame: Up to 7 days after surgery]
- ICU discharge time [Time frame: At ICU discharge, an average of one day after surgery]
- Hospital discharge [Time frame: At hospital discharge, an average of one week after surgery]
- In-hospital mortality [Time frame: At hospital discharge, an average of one week after surgery]
- 30-day mortality [Time frame: Up to 30 days after surgery]
- Hospital readmission [Time frame: Up to 30 days after surgery]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Canada · 1 center
- Centre Hospitalier de l'Université de Montréal (CHUM) — Montreal
Identifiers
NCT: NCT05225272 · 21.320