Evaluation Of Caudal Epidural Anatomy By Ultrasonography İn Pediatric Patients
1 other identifier
observational
348
1 country
1
Brief Summary
Detailed study of ultrasonographic caudal epidural anatomy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2019
CompletedStudy Start
First participant enrolled
January 28, 2019
CompletedFirst Posted
Study publicly available on registry
January 31, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2020
CompletedJanuary 11, 2022
April 1, 2021
11 months
January 24, 2019
December 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Definition Of Dural Sac Termination Level By Ultrasonography
After general anesthesia, patient will be placed in lateral decubitus position. First, a 12 MHz lineer ultrasound transducer will be placed transversely to obtain the transverse view of sacral hiatus; in this view we will try to show two sacral cornua, sacrococcygeal ligament, posterior sacral bone and caudal epidural depth. Secondly, transducer will be turned parallel to the midline or paravertebral to obtain longitudinal view; in longitudinal view we will try to obtain the images of sacral vertebral corpuses, caudal epidural area and dural sac. We will try to determine the level of dural sac termination according to a part of vertabral corpus or an intervertebral distance.
5 minutes
Distance Between Dural Sac Termination Level And Placement Of Caudal Epidural Needle
Distance Between Dural Sac Termination Level And Placement Of Caudal Epidural Needle will be measured under longitudinal ultrasound view
5 minutes
Definition Of Average Caudal Epidural Depth By Ultrasonography
Definition of caudal epidural depth by ultrasonography will be obtained under transverse view for every patient and average value will be defined for every age group.
5 minutes
Secondary Outcomes (1)
Determination Of Sacral Cornua As An Anatomic Landmark And Confirmation By Ultrasonography
5 minutes
Study Arms (3)
Group I
Caudal Epidural Ultrasonography will be performed in patients aged between 1-24 months
Group II
Caudal Epidural Ultrasonography will be performed in patients aged between 25-48 months
Group III
Caudal Epidural Ultrasonography will be performed in patients aged between 49-84 months
Interventions
Eligibility Criteria
Pediatric patients who are admitted to operating room for any pediatric surgery
You may qualify if:
- Pediatric patients who applied for any pediatric surgery from 20 january to 20 july
You may not qualify if:
- Premature patients
- Patients who have any sendromic diagnosis
- Patients who have any musculoskeletal abnormalities
- Patients who have any spinal abnormalities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Istanbul Universitylead
- Pinar Kendigelencollaborator
- Ayse Cigdem Tutuncucollaborator
- Kaya, Guner, M.D.collaborator
Study Sites (1)
Cerrahpasa Medical Faculty
Istanbul, 34098, Turkey (Türkiye)
Study Officials
- PRINCIPAL INVESTIGATOR
Celal Kaya, MD
Istanbul University
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- resident
Study Record Dates
First Submitted
January 24, 2019
First Posted
January 31, 2019
Study Start
January 28, 2019
Primary Completion
December 30, 2019
Study Completion
January 20, 2020
Last Updated
January 11, 2022
Record last verified: 2021-04