NCT02785081

Brief Summary

The purpose of this study is to evaluate the thoracic skin to epidural space depth in children and define the ratio between the straight and inclined thoracic skin to epidural depth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
109

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2016

Shorter than P25 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

May 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 27, 2016

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 14, 2016

Status Verified

June 1, 2016

Enrollment Period

1 month

First QC Date

May 24, 2016

Last Update Submit

June 13, 2016

Conditions

Anesthesia, EpiduralMagnetic Resonance Imaging

Keywords

Thoracic epiduralMagnetic Resonance ImagingChildren

Outcome Measures

Primary Outcomes (1)

  • Depth of thoracic epidural space in children

    Derive a formula for predicting the thoracic skin epidural depth in children

    3 months

Eligibility Criteria

Age1 Month - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

MRI images of children aged 1 month to 8 years undergoing Magnetic Resonance Imaging evaluation unrelated to spine pathology were studied.

You may qualify if:

  • Children aged 1 month to 8 years undergoing Magnetic Resonance Imaging evaluation

You may not qualify if:

  • Patients with scoliosis, myelomeningocele, tumors of the spinal cord or vertebral bodies, spina bifida, tethered cord, spinal metastasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Fahad Medical City

Riyadh, Riyadh Region, 11525, Saudi Arabia

Location

Related Publications (2)

  • Franklin AD, Lorinc AN, Shotwell MS, Greene EB, Wushensky CA. Evaluation of the skin to epidural and subarachnoid space distance in young children using magnetic resonance imaging. Reg Anesth Pain Med. 2015 May-Jun;40(3):245-8. doi: 10.1097/AAP.0000000000000234.

    PMID: 25899953BACKGROUND

  • Kil HK, Cho JE, Kim WO, Koo BN, Han SW, Kim JY. Prepuncture ultrasound-measured distance: an accurate reflection of epidural depth in infants and small children. Reg Anesth Pain Med. 2007 Mar-Apr;32(2):102-6. doi: 10.1016/j.rapm.2006.10.005.

    PMID: 17350519BACKGROUND

Study Officials

  • Tariq M Wani, MD

    King Fahad Medical City, Riyadh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Pediatric Anesthesia

Study Record Dates

First Submitted

May 24, 2016

First Posted

May 27, 2016

Study Start

May 1, 2016

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

June 14, 2016

Record last verified: 2016-06

Locations

SA(1)