- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05665712
Pediatric Enhanced Recovery After Cardiac Surgery (PERCS)
October 3, 2023 updated by: University of Alberta
Pediatric Enhanced Recovery After Cardiac Surgery: a Single-centre Retrospective Study
Identify our institution's current perioperative management strategies for pediatric cardiac surgery patients. Identify predictive factors for receiving perioperative care following P-ERACS strategies.
Compare outcomes between P-ERACS and non-P-ERACS patients
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
study aims to 1) assess our institution's current perioperative management strategies for pediatric cardiac surgery patients, 2) identify which patient population would be appropriate for inclusion in a pediatric ERACS (P-ERACS) program, and 3) compare the outcomes of patients whose perioperative care followed general consensus P-ERACS strategies (P-ERACS patients) and those whose perioperative care did not (non-P-ERACS patients).
Results from this study will inform current efforts to establish a local P-ERACS protocol, and facilitate the initiation of a clinical trial to assess adherence to a P-ERACS pathway as well as the impact of such a pathway on patient outcomes.
Study Type
Observational
Enrollment (Actual)
483
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mancho Ng, MD
- Phone Number: +1 587 590 5690
- Email: mancho@ualberta.ca
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G2R7
- University of Alberta
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
all pediatric patients (<18 years of age) who underwent elective cardiac surgery requiring cardiopulmonary bypass (CPB)
Description
Inclusion Criteria:
- all pediatric patients (<18 years of age) who underwent elective cardiac surgery requiring cardiopulmonary bypass (CPB)
Exclusion Criteria:
- Emergency procedures and transplantation (heart, lung, heart and lung)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
time to extubation
Time Frame: 24 hours
|
time to extubation
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of stay
Time Frame: 48 hours
|
LOS in ICU
|
48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.
- Engelman DT, Ben Ali W, Williams JB, Perrault LP, Reddy VS, Arora RC, Roselli EE, Khoynezhad A, Gerdisch M, Levy JH, Lobdell K, Fletcher N, Kirsch M, Nelson G, Engelman RM, Gregory AJ, Boyle EM. Guidelines for Perioperative Care in Cardiac Surgery: Enhanced Recovery After Surgery Society Recommendations. JAMA Surg. 2019 Aug 1;154(8):755-766. doi: 10.1001/jamasurg.2019.1153.
- Noss C, Prusinkiewicz C, Nelson G, Patel PA, Augoustides JG, Gregory AJ. Enhanced Recovery for Cardiac Surgery. J Cardiothorac Vasc Anesth. 2018 Dec;32(6):2760-2770. doi: 10.1053/j.jvca.2018.01.045. Epub 2018 Jan 31.
- Roy N, Parra MF, Brown ML, Sleeper LA, Nathan M, Sefton BA, Baird CW, Mistry KP, Del Nido PJ. Initial experience introducing an enhanced recovery program in congenital cardiac surgery. J Thorac Cardiovasc Surg. 2020 Nov;160(5):1313-1321.e5. doi: 10.1016/j.jtcvs.2019.10.049. Epub 2019 Oct 24.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2019
Primary Completion (Actual)
August 15, 2023
Study Completion (Actual)
August 15, 2023
Study Registration Dates
First Submitted
December 16, 2022
First Submitted That Met QC Criteria
December 16, 2022
First Posted (Actual)
December 27, 2022
Study Record Updates
Last Update Posted (Actual)
October 5, 2023
Last Update Submitted That Met QC Criteria
October 3, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00104502
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pediatric ALL
-
University of BirminghamCompletedCancer | Pediatric ALL | Pediatric Solid Tumor | Pediatric AMLUnited Kingdom, Australia, Netherlands
-
Samsung Medical CenterMinistry of Health, Republic of KoreaRecruitingRelapsed Pediatric AML | Refractory Pediatric AML | Relapsed Pediatric Solid Tumor | Refractory Pediatric Solid TumorKorea, Republic of
-
National Institute of Allergy and Infectious Diseases...Clinical Trials in Organ Transplantation in ChildrenCompletedPediatric Heart Transplantation | Pediatric Heart Transplant Recipients | Pediatric Cardiac TransplantationUnited States
-
University Hospital, Strasbourg, FranceTerminatedPediatric Lung Ultrasound | Pediatric Chest Radiography | Pediatric Lung DiagnosisFrance
-
TC Erciyes UniversityCompletedPediatric Cancer | Pediatric Brain Tumor | Pediatric Solid TumorTurkey
-
National Institute of Allergy and Infectious Diseases...National Heart, Lung, and Blood Institute (NHLBI)TerminatedPediatric Heart Transplantation | Pediatric Heart Transplant RecipientsUnited States, Canada
-
University of CalgaryCanadian Institutes of Health Research (CIHR); Alberta Children's Hospital; Stollery... and other collaboratorsNot yet recruitingPediatric Cancer | Pediatric Hematology
-
Children's Healthcare of AtlantaEmory UniversityCompletedPediatric Preoperative Anxiety, Pediatric CopingUnited States
-
Hospital Moinhos de VentoNot yet recruitingAdolescent | Telemedicine | Critical Care | Pediatric | Intensive Care Units, Pediatric
-
Samsung Medical CenterMinistry of Health, Republic of KoreaNot yet recruitingRelapsed Pediatric Solid Tumor | Refractory Pediatric Solid TumorKorea, Republic of
Clinical Trials on enhanced recovery
-
Sir Run Run Shaw HospitalUnknown
-
University of Alabama at BirminghamRecruitingHIV Infections | Opioid-Related Disorders | Pre-Exposure Prophylaxis (PrEP)United States
-
University of Cape TownActive, not recruiting
-
Centre hospitalier de l'Université de Montréal...Centre de Recherche du Centre Hospitalier de l'Université de MontréalCompleted
-
Instituto Brasileiro de Controle do CancerWithdrawnEnhanced Recovery After Surgery | Gynecologic Surgical ProceduresBrazil
-
Cliniques universitaires Saint-Luc- Université...Completed
-
University Hospital of FerraraUniversità degli Studi di Ferrara; Ministero della Salute, ItalyCompletedLaparoscopic Surgery | Colorectal Surgery | Recovery of Function
-
University of ArkansasActive, not recruitingColoRectal Cancer and Inflammatory Bowel DiseaseUnited States
-
University Hospital, AngersCompletedSurgery | Small Bowel ObstructionFrance
-
Groupe Hospitalier de la Rochelle Ré AunisCompletedArthroplasty ComplicationsFrance