Anesthesia, EpiduralNCT02785081
Thoracic Epidural Depth in Children Using Magnetic Resonance Imaging.Magnetic Resonance Imaging
An observational study of Anesthesia, Epidural and Magnetic Resonance Imaging, run by King Fahad Medical City at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 1 month to 8 years
- Conditions the study is for
- Anesthesia, Epidural, Magnetic Resonance Imaging
- How many people
- 109 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- May 2016to Jun 2016
- 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 1 month to 8 years
- All sexes
- No healthy volunteers
- Child
Study population: MRI images of children aged 1 month to 8 years undergoing Magnetic Resonance Imaging evaluation unrelated to spine pathology were studied.
Who may be able to join
- Children aged 1 month to 8 years undergoing Magnetic Resonance Imaging evaluation
Who cannot join
- Patients with scoliosis, myelomeningocele, tumors of the spinal cord or vertebral bodies, spina bifida, tethered cord, spinal metastasis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thoracic Epidural Depth in Children Using Magnetic Resonance Imaging
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.
Read the detailed 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.
- Conditions
- Anesthesia, Epidural, Magnetic Resonance Imaging
- Keywords
- Thoracic epidural, Magnetic Resonance Imaging, Children
What is being measured
The primary outcome is the main question the study is designed to answer.
Depth of thoracic epidural space in children
Derive a formula for predicting the thoracic skin epidural depth in children
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, EpiduralStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Fahad Medical City
- Sponsor type
- Other government
- Collaborators
- Nationwide Children's Hospital
- Responsible party
- Principal investigator, Tariq Wani, King Fahad Medical City
- Investigators
- Tariq M Wani, MD, Principal investigator, King Fahad Medical City, Riyadh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785081
- Sponsor's protocol ID
- H-01-R-012, 16-207
- Status last verified
- Jun 2016
- First submitted
- 24 May 2016
- Last updated
- 14 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25899953Kil 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.
PubMed 17350519
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracic Epidural Depth in Children Using Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT02785081
- Acronym / sponsor ID
- H-01-R-012, 16-207
- Conditions
- Anesthesia, Epidural, Magnetic Resonance Imaging
- Keywords
- Thoracic epidural, Magnetic Resonance Imaging, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- King Fahad Medical CityOther government
- Collaborators
- Nationwide Children's Hospital
- Study start
- May 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 27 May 2016 (estimated)
- 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.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 month to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- MRI images of children aged 1 month to 8 years undergoing Magnetic Resonance Imaging evaluation unrelated to spine pathology were studied.
Key inclusion criteria (1 listed)
- Children aged 1 month to 8 years undergoing Magnetic Resonance Imaging evaluation
Key exclusion criteria (1 listed)
- Patients with scoliosis, myelomeningocele, tumors of the spinal cord or vertebral bodies, spina bifida, tethered cord, spinal metastasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Depth of thoracic epidural space in children
Time frame: 3 months
Derive a formula for predicting the thoracic skin epidural depth in children
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 14 Jun 2016.
- Background: PubMed 25899953Franklin 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.
- Background: PubMed 17350519Kil 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.
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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.
Tariq M Wani, MD principal investigator
King Fahad Medical City, Riyadh
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 Anesthesia, Epidural and Magnetic Resonance Imaging, run by King Fahad Medical City at 1 site in Saudi Arabia.
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 14 Jun 2016. 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 Saudi Arabia. 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?
Depth of thoracic epidural space in children (time frame: 3 months). 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 NCT02785081, which also lists 2 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 14 Jun 2016.