Clinical trial NCT05665712: Pediatric Enhanced Recovery After Cardiac Surgery
Official title: Pediatric Enhanced Recovery After Cardiac Surgery: a Single-centre Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ERAS
Pediatric ALL
Congenital Heart Disease
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 483
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all pediatric patients (\&lt;18 years of age) who underwent elective cardiac surgery requiring cardiopulmonary bypass (CPB)

Brief summary: 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

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.

Eligibility criteria: Inclusion Criteria:

* all pediatric patients (\&lt;18 years of age) who underwent elective cardiac surgery requiring cardiopulmonary bypass (CPB)

Exclusion Criteria:

* Emergency procedures and transplantation (heart, lung, heart and lung)

Primary outcomes:
measure: time to extubation
timeFrame: 24 hours
Secondary outcomes:
measure: Length of stay
timeFrame: 48 hours
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.