Clinical trial NCT05225272: Effectiveness of an Enhanced Recovery After Surgery Protocol in Patients Undergoing On-pump Cardiac Surgery
Official title: Evaluation of the Effectiveness of an Enhanced Recovery After Surgery Protocol in Patients Undergoing On-pump Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Disorder; Heart, Functional, Postoperative, Cardiac Surgery
Keywords: On-pump cardiac surgery
Enhanced recovery after surgery
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The investigators aim to conduct a bidirectional cohort study including on-pump cardiac surgery patients. This study will take place at the Centre Hospitalier de l'Université de Montréal (CHUM).

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.

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.

Primary outcomes:
measure: Time before patient extubation
timeFrame: From the end of the surgery to extubation, up to 1 week
Secondary outcomes:
measure: Incidence of reintubation
timeFrame: Up to 24 hours after extubation
measure: Acute pain scores using the Numerical Rating Scale (NRS)
timeFrame: 8, 16, 24 and 48 hours after surgery
measure: Opioid consumption
timeFrame: 8, 16, 24 and 48 hours after surgery
measure: Opioid side effects
timeFrame: 8, 16, 24 and 48 hours after surgery
measure: Incidence of delirium in the intensive care unit (ICU) using the ICDSC score
timeFrame: Up to 7 days after surgery or ICU discharge, whichever comes first
measure: Postoperative complications
timeFrame: Up to 7 days after surgery
measure: ICU discharge time
timeFrame: At ICU discharge, an average of one day after surgery
measure: Hospital discharge
timeFrame: At hospital discharge, an average of one week after surgery
measure: In-hospital mortality
timeFrame: At hospital discharge, an average of one week after surgery
measure: 30-day mortality
timeFrame: Up to 30 days after surgery
measure: Hospital readmission
timeFrame: Up to 30 days after surgery
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal (CHUM)
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Alex Moore, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: