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NCT02785081 Clinical Trial

Thoracic Epidural Depth in Children Using Magnetic Resonance Imaging.Magnetic Resonance Imaging

Magnetic Resonance Imaging Clinical Trial

Official title:
Thoracic Epidural Depth in Children Using Magnetic Resonance Imaging

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02785081
Other study ID # H-01-R-012, 16-207
Secondary ID
Status Completed
Phase N/A
First received May 24, 2016
Last updated June 13, 2016
Start date May 2016
Est. completion date June 2016

Study information
Verified date June 2016
Source King Fahad Medical City
Contact n/a
Is FDA regulated No
Health authority Saudi Arabia: 'Ministry of Health'
Study type Observational

Clinical Trial 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.

Description:

Thoracic epidural in children confers clinical benefits but are technically challenging. The prediction of thoracic skin epidural depth (SED) might increase the success rate and decrease complications. Magnetic resonance imaging (MRI) is the most comprehensive imaging modality of the spine, and the measurements derived can be more accurate.

The present study is based on Magnetic Resonance Imaging (MRI)-based measurements to evaluate the thoracic SED and define the ratio between the straight and inclined SED at the two thoracic levels (T6-7 and T9-10) in children.

Recruitment information / eligibility
Status Completed
Enrollment 109
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender Both
Age group 1 Month to 8 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Saudi Arabia King Fahad Medical City Riyadh

Sponsors (2)
Lead Sponsor Collaborator
King Fahad Medical City Nationwide Children's Hospital

Country where clinical trial is conducted

Saudi Arabia, 

References & 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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Depth of thoracic epidural space in children Derive a formula for predicting the thoracic skin epidural depth in children 3 months No
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