ObesityNCT04095117
Evaluation of Sagittal Abdominal Diameter as a Predictor of the Skin to Epidural Space Distance in Obese Patients
An observational study of Obesity and Epidural; Anesthesia, Headache, run by Ain Shams University at 2 sites in Egypt.
Trial summary
The aim of this study is to evaluate the use of the sagittal abdominal diameter (SAD) as a potential predictor of the skin to epidural space distance (SESD) and to compare its accuracy versus that of the BMI as a previously validated predictor Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Epidural; Anesthesia, Headache
- What is being tested?
- Epidural block
- Type of treatment
- Surgery or procedure
- How many people
- 135 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jul 2019to 1 Jul 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects with BMI of 30 to 39.9 kg/m2 who are scheduled for lower extremity surgery under epidural anesthesia.
Who may be able to join
- Age 18 years or older
- BMI 30 to 39.9
- Either sex
- Elective surgery on lower extremities performed under epidural anesthesia
Who cannot join
- Pregnant women
- Contraindications to epidural block
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Ain Shams University Hospitals
Cairo, 11517
Hany Eldhahaby, MD, +201227463000, hanyzahaby@hotmail.com
- Recruiting
Ain Shams University Hospitals
Cairo
Hany Eldhahaby, MD, +201227463000, hanyzahaby@hotmail.com
About this study
The aim of this study is to evaluate the use of the sagittal abdominal diameter (SAD) as a potential predictor of the skin to epidural space distance (SESD) and to compare its accuracy versus that of the BMI as a previously validated predictor
Read the detailed description
Adult patients from either sex with BMI from 30-39.9 kg/m², scheduled for lower abdominal operations or surgeries on the lower extremities under epidural anesthesia will be eligible. Pregnant women will be excluded.
The sagittal abdominal diameter (SAD), which is the anteroposterior diameter of the abdomen in the supine position at L4-5 level will be measured in all subjects along with the BMI prior to epidural placement.
The epidural space will be accessed at the L3-L4 or L4-L5 interspace with a 16-G or 18-G Tuohy needle using a loss of resistance to saline technique. The proper placement of the needle in the epidural space will be confirmed by connecting the hub of the epidural needle via a rigid extension tubing to a saline filled pressure transducer to demonstrate the characteristic epidural space pressure wave changes described by Arnuntasupakul and his colleagues (2016), which is a pulsatile waveform synchronized with arterial pulsations.
The distance from skin to epidural space will be marked on the needle with a sterile marker and will be recorded.
An epidural catheter will be passed into the epidural space and the epidural block will be activated in the usual way until adequate sensory and motor block is established in both lower extremities (Bromage score 3-4).
Successful placement of the epidural needle will be considered if the following two criteria are fulfilled: (1) Detection of the characteristic epidural pressure wave form as described above and (2) Establishment of adequate sensory and motor block.
Simple linear regression will be used to deduce an equation relating the skin to epidural space distance to the sagittal abdominal diameter or to the BMI.
- Conditions
- Obesity, Epidural; Anesthesia, Headache
- Being tested
- Epidural block
- Medical subject headings
- Obesity, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural blockProcedure or surgery
Epidural catheter will be inserted at the L3-L4 or L4-L5 interspace in obese subjects scheduled for surgery on the lower extremities under epidural anesthesia.
The sagittal abdominal diameter, BMI and skin to epidural space distance will be recorded.
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the sagittal abdominal diameter for prediction of the skin to epidural space distance
Actual skin to epidural space distance will be determined and regressed on the sagittal abdominal diameter to determine accuracy of the latter for prediction of the former
Measured: 18 months
Secondary outcomes (1)
Accuracy of the BMI for prediction of the skin to epidural space distance
Actual skin to epidural space distance will be determined and regressed on the BMI to determine accuracy of the latter for prediction of the former
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start1 Jul 2019
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh M. Hakim, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095117
- Sponsor's protocol ID
- FMASU MD 153/2019
- Status last verified
- Jul 2024
- First submitted
- 17 Sep 2019
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sagittal Abdominal Diameter as a Predictor of the Skin to Epidural Space Distance in Obese Patients
- ClinicalTrials.gov ID
- NCT04095117
- Acronym / sponsor ID
- FMASU MD 153/2019
- Conditions
- Obesity, Epidural; Anesthesia, Headache
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 19 Sep 2019 (actual)
- 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 aim of this study is to evaluate the use of the sagittal abdominal diameter (SAD) as a potential predictor of the skin to epidural space distance (SESD) and to compare its accuracy versus that of the BMI as a previously validated predictor
Detailed description
Adult patients from either sex with BMI from 30-39.9 kg/m², scheduled for lower abdominal operations or surgeries on the lower extremities under epidural anesthesia will be eligible. Pregnant women will be excluded.
The sagittal abdominal diameter (SAD), which is the anteroposterior diameter of the abdomen in the supine position at L4-5 level will be measured in all subjects along with the BMI prior to epidural placement.
The epidural space will be accessed at the L3-L4 or L4-L5 interspace with a 16-G or 18-G Tuohy needle using a loss of resistance to saline technique. The proper placement of the needle in the epidural space will be confirmed by connecting the hub of the epidural needle via a rigid extension tubing to a saline filled pressure transducer to demonstrate the characteristic epidural space pressure wave changes described by Arnuntasupakul and his colleagues (2016), which is a pulsatile waveform synchronized with arterial pulsations.
The distance from skin to epidural space will be marked on the needle with a sterile marker and will be recorded.
An epidural catheter will be passed into the epidural space and the epidural block will be activated in the usual way until adequate sensory and motor block is established in both lower extremities (Bromage score 3-4).
Successful placement of the epidural needle will be considered if the following two criteria are fulfilled: (1) Detection of the characteristic epidural pressure wave form as described above and (2) Establishment of adequate sensory and motor block.
Simple linear regression will be used to deduce an equation relating the skin to epidural space distance to the sagittal abdominal diameter or to the BMI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects with BMI of 30 to 39.9 kg/m2 who are scheduled for lower extremity surgery under epidural anesthesia.
Key inclusion criteria (4 listed)
- Age 18 years or older
- BMI 30 to 39.9
- Either sex
- Elective surgery on lower extremities performed under epidural anesthesia
Key exclusion criteria (2 listed)
- Pregnant women
- Contraindications to epidural block
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural blockEpidural catheter will be inserted at the L3-L4 or L4-L5 interspace in obese subjects scheduled for surgery on the lower extremities under epidural anesthesia. The sagittal abdominal diameter, BMI and skin to epidural space distance will be recorded. | Procedure or surgery | – |
Primary outcome
Accuracy of the sagittal abdominal diameter for prediction of the skin to epidural space distance
Time frame: 18 months
Actual skin to epidural space distance will be determined and regressed on the sagittal abdominal diameter to determine accuracy of the latter for prediction of the former
1 secondary outcome
Accuracy of the BMI for prediction of the skin to epidural space distance
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Epidural; Anesthesia, Headache, run by Ain Shams University at 2 sites in Egypt.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sameh M Hakim, MD (+201286824970, hakimsm@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the sagittal abdominal diameter for prediction of the skin to epidural space distance (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2024.