NCT02652117

Brief Summary

This retrospective review presents a comparison of pediatric patients less than 5 years old undergoing cardiac surgery with general anesthesia with spinal, caudal epidural, or caudal epidural with catheter anesthesia from July 2007 to July 2013 observing differences in time to extubation, reintubation, and hypercarbia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
545

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2007

Longer than P75 for all trials

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

July 1, 2007

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 11, 2016

Completed
Last Updated

May 16, 2023

Status Verified

May 1, 2023

Enrollment Period

6 years

First QC Date

January 7, 2016

Last Update Submit

May 12, 2023

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • To expect difference in time to extubation

    24 hours

Eligibility Criteria

AgeUp to 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Cardiac Pediatric Patients less than 5 years old

You may qualify if:

  • Must be pediatric patients undergoing cardiac surgery under the age of 5 years old between the years 2007 and 2013

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Fawcett WJ, Edwards RE, Quinn AC, MacDonald IA, Hall GM. Thoracic epidural analgesia started after cardiopulmonary bypass. Adrenergic, cardiovascular and respiratory sequelae. Anaesthesia. 1997 Apr;52(4):294-9. doi: 10.1111/j.1365-2044.1997.80-az0088.x.

    PMID: 9135178BACKGROUND

  • Liu S, Carpenter RL, Neal JM. Epidural anesthesia and analgesia. Their role in postoperative outcome. Anesthesiology. 1995 Jun;82(6):1474-506. doi: 10.1097/00000542-199506000-00019. No abstract available.

    PMID: 7793661BACKGROUND

Study Officials

  • Sudhakar Subramani, MD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 7, 2016

First Posted

January 11, 2016

Study Start

July 1, 2007

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

May 16, 2023

Record last verified: 2023-05