UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020413 |
|---|---|
| Receipt number | R000023573 |
| Scientific Title | Measuring skin to subarachnoid space depth in Egyptian population, A prospective cohort study. |
| Date of disclosure of the study information | 2016/01/04 |
| Last modified on | 2016/01/18 01:19:43 |
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Basic information
Public title
Measuring skin to subarachnoid space depth in Egyptian population, A prospective cohort study.
Acronym
Measuring skin to subarachnoid space depth in Egyptian population, A prospective cohort study.
Scientific Title
Measuring skin to subarachnoid space depth in Egyptian population, A prospective cohort study.
Scientific Title:Acronym
Measuring skin to subarachnoid space depth in Egyptian population, A prospective cohort study.
Region
| Africa |
Condition
Condition
This study tries to measure the skin to subarachniod distance in Egyptian population generally and in individual male, females and pregnant females and find a differences between them
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to measure the skin to subarachnoid distance in Egyptian population
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
to know the skin to subarachnoid distance in egyptian population and put a formula for its calculation by approach the subarachniod space in midline by a spinal needle and put a mark on that needle and measure a distance by a ruler and find a correlation between it and bodymass index
Key secondary outcomes
to find which formula is applicable in egyptian population
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
we insert a spinal needle in l3-4 space and measure the distance from skin to subarachnoid space using a spescific measurement
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
400 adult Egyptian patients (age is 18- 60byears) of either sex, ASA I&II, who will submitted for elective surgical procedures under spinal anesthesia
Key exclusion criteria
Patients with neurological disorder, history of seizures, spinal anomaly, low back pain, prior back surgery, skin infection at puncture site, sepsis, drug allergies and coagulation defects will be excluded. Pregnant females with hypertensive disorder, less than term pregnancy or those scheduled for surgery other than caesarean delivery
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hani I, Taman |
Organization
Mansoura faculty of medicine, anestheasia department
Division name
Mansoura university main hospital
Zip code
Address
17, elgomhoria street, mansoura, egypt
TEL
+81-2050220772
hani_taman@mans.edu.eg
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hani I, Taman |
Organization
Mansoura faculty of medicine, anestheasia department
Division name
Mansoura university main hospital
Zip code
Address
17 elgomhoria street, mansoura, egypt
TEL
+81-2050220772
Homepage URL
hani_taman@mans.edu.eg
Sponsor or person
Institute
Mansoura Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 01 | Day |
Last modified on
| 2016 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023573
