Disorder; Heart, Functional, Postoperative, Cardiac SurgeryERASCsNCT05225272
Effectiveness of an Enhanced Recovery After Surgery Protocol in Patients Undergoing On-pump Cardiac Surgery
An observational study of Disorder; Heart, Functional, Postoperative, Cardiac Surgery, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Disorder; Heart, Functional, Postoperative, Cardiac Surgery
- What is being tested?
- Enhanced Recovery Program for on-pump cardiac surgery
- How many people
- 92 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2026to 1 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
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).
Who may be able to join
- On-pump cardiac surgery
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 0A9
Cédrick Zaouter, MD, FRCPC, 514-890-8000 ext. 12132, cedrickzaouter@gmail.com
Julie Desroches, PhD, 514-890-8000 ext. 24542, anesthesie.recherche.chum@ssss.gouv.qc.ca
About this study
Official title: Evaluation of the Effectiveness of an Enhanced Recovery After Surgery Protocol in Patients Undergoing On-pump Cardiac Surgery
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.
Read the 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.
- Being tested
- Enhanced Recovery Program for on-pump cardiac surgery
- Keywords
- On-pump cardiac surgery, Enhanced recovery after surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Recovery Program for on-pump cardiac surgeryOther
Implementation of a Enhanced Recovery Program for on-pump cardiac surgery patients
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing on-pump cardiac surgery | The investigators aim to conduct a bidirectional (prospective and retrospective) observational, cohort study including on-pump cardiac surgery patients. Receives: Other: Enhanced Recovery Program for on-pump cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time before patient extubation
Time elapsed between final wound dressing and removal of the endotracheal tube, before and after implementation of the cardiac ERP.
Measured: From the end of the surgery to extubation, up to 1 week
Secondary outcomes (11)
Incidence of reintubation
Need for postoperative endotracheal intubation given the occurrence of respiratory or non-respiratory complication after extubation.
Measured: Up to 24 hours after extubation
Acute pain scores using the Numerical Rating Scale (NRS)
Using the verbal NRS, where 0 means "no pain" and 10 "worst pain imaginable"
Measured: 8, 16, 24 and 48 hours after surgery
Opioid consumption
Opioid consumption converted in intravenous morphine equivalents
Measured: 8, 16, 24 and 48 hours after surgery
Opioid side effects
Including nausea, vomiting, sedation and pruritus
Measured: 8, 16, 24 and 48 hours after surgery
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.
Measured: Up to 7 days after surgery or ICU discharge, whichever comes first
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)
Measured: Up to 7 days after surgery
ICU discharge time
Time and date when the patient is transferred to ward or step-down unit
Measured: At ICU discharge, an average of one day after surgery
Hospital discharge
Time and date when the patient is discharged from the hospital
Measured: At hospital discharge, an average of one week after surgery
In-hospital mortality
Occurrence of death during hospitalization
Measured: At hospital discharge, an average of one week after surgery
30-day mortality
Occurrence of death during the first 30 days following surgery
Measured: Up to 30 days after surgery
Hospital readmission
Need for readmission following discharge after index surgery
Measured: Up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder; Heart, Functional, Postoperative, Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alex Moore, MD, FRCPC, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225272
- Sponsor's protocol ID
- 21.320
- Acronym
- ERASCs
- Status last verified
- Sep 2025
- First submitted
- 26 Jan 2022
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of an Enhanced Recovery After Surgery Protocol in Patients Undergoing On-pump Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05225272
- Acronym / sponsor ID
- ERASCs / 21.320
- Keywords
- On-pump cardiac surgery, Enhanced recovery after surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 4 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing on-pump cardiac surgery | – | Other: Enhanced Recovery Program for on-pump cardiac surgeryThe investigators aim to conduct a bidirectional (prospective and retrospective) observational, cohort study including on-pump cardiac surgery patients. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- On-pump cardiac surgery
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Recovery Program for on-pump cardiac surgeryImplementation of a Enhanced Recovery Program for on-pump cardiac surgery patients | Other | Patients undergoing on-pump cardiac surgery |
Primary outcome
Time before patient extubation
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.
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alex Moore, MD, FRCPC principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disorder; Heart, Functional, Postoperative, Cardiac Surgery, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alex Moore, MD, FRCPC (514-890-8000 ext. 12132, alex.moore@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time before patient extubation (time frame: From the end of the surgery to extubation, up to 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.