ERASPERCSNCT05665712
Pediatric Enhanced Recovery After Cardiac Surgery
An observational study of ERAS and Pediatric ALL, run by University of Alberta at 1 site in Canada.
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 Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- ERAS, Pediatric ALL, Congenital Heart Disease
- What is being tested?
- enhanced recovery
- Type of treatment
- Surgery or procedure
- How many people
- 483 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2019to 15 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: all pediatric patients (\<18 years of age) who underwent elective cardiac surgery requiring cardiopulmonary bypass (CPB)
Who may be able to join
- all pediatric patients (\<18 years of age) who underwent elective cardiac surgery requiring cardiopulmonary bypass (CPB)
Who cannot join
- Emergency procedures and transplantation (heart, lung, heart and lung)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- ERAS, Pediatric ALL, Congenital Heart Disease
- Being tested
- enhanced recovery
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enhanced recoveryProcedure or surgery
bundle of factors that have been shown to help with recovery in other surgical services such as good pain control, early ambulation, early nutrition
What is being measured
The primary outcome is the main question the study is designed to answer.
time to extubation
time to extubation
Measured: 24 hours
Secondary outcomes (1)
Length of stay
LOS in ICU
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start1 Nov 2019
- Primary completion15 Aug 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ERASStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 483 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665712
- Sponsor's protocol ID
- Pro00104502
- Acronym
- PERCS
- Status last verified
- Oct 2023
- First submitted
- 16 Dec 2022
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28097305Noss 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.
PubMed 29503121Engelman 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.
PubMed 31054241Roy 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.
PubMed 31859070
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Enhanced Recovery After Cardiac Surgery: a Single-centre Retrospective Study
- ClinicalTrials.gov ID
- NCT05665712
- Acronym / sponsor ID
- PERCS / Pro00104502
- Conditions
- ERAS, Pediatric ALL, Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 483 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 27 Dec 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- all pediatric patients (\<18 years of age) who underwent elective cardiac surgery requiring cardiopulmonary bypass (CPB)
Key inclusion criteria (1 listed)
- all pediatric patients (\<18 years of age) who underwent elective cardiac surgery requiring cardiopulmonary bypass (CPB)
Key exclusion criteria (1 listed)
- Emergency procedures and transplantation (heart, lung, heart and lung)
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 recoverybundle of factors that have been shown to help with recovery in other surgical services such as good pain control, early ambulation, early nutrition | Procedure or surgery | – |
Primary outcome
time to extubation
Time frame: 24 hours
time to extubation
1 secondary outcome
Length of stay
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Background: PubMed 28097305Ljungqvist 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.
- Background: PubMed 29503121Noss 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.
- Background: PubMed 31054241Engelman 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.
- Background: PubMed 31859070Roy 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.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 ERAS and Pediatric ALL, run by University of Alberta 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 1 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: finished, as of the sponsor's last update on 5 Oct 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to extubation (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05665712, which also lists 4 linked publications.
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 5 Oct 2023.