NCT05665712

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
483

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 27, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
Last Updated

October 5, 2023

Status Verified

October 1, 2023

Enrollment Period

3.8 years

First QC Date

December 16, 2022

Last Update Submit

October 3, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • time to extubation

    time to extubation

    24 hours

Secondary Outcomes (1)

  • Length of stay

    48 hours

Interventions

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

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

all pediatric patients (\<18 years of age) who underwent elective cardiac surgery requiring cardiopulmonary bypass (CPB)

You may qualify if:

  • all pediatric patients (\<18 years of age) who underwent elective cardiac surgery requiring cardiopulmonary bypass (CPB)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G2R7, Canada

Location

Related Publications (4)

  • 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.

    PMID: 28097305BACKGROUND
  • 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.

    PMID: 29503121BACKGROUND
  • 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.

    PMID: 31054241BACKGROUND
  • 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.

    PMID: 31859070BACKGROUND

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaHeart Defects, Congenital

Interventions

Enhanced Recovery After Surgery

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Perioperative CareSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2022

First Posted

December 27, 2022

Study Start

November 1, 2019

Primary Completion

August 15, 2023

Study Completion

August 15, 2023

Last Updated

October 5, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations