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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05665712
Other study ID # Pro00104502
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2019
Est. completion date August 15, 2023

Study information

Verified date October 2023
Source University of Alberta
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 483
Est. completion date August 15, 2023
Est. primary completion date August 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 18 Years
Eligibility 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 Design


Intervention

Procedure:
enhanced recovery
bundle of factors that have been shown to help with recovery in other surgical services such as good pain control, early ambulation, early nutrition

Locations

Country Name City State
Canada University of Alberta Edmonton Alberta

Sponsors (1)

Lead Sponsor Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary time to extubation time to extubation 24 hours
Secondary Length of stay LOS in ICU 48 hours
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