ObesityNCT00439998
Ultrasound Imaging For Facilitating Labour Epidurals in Obese Parturients
A study testing Ultrasound in people with Obesity, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial summary
The efficacy of an epidural depends mainly on accurate placement of the catheter in the epidural space. Therefore, identification of the epidural space is the most vital part of the procedure. Obese patients represent the most challenging group for the identification of anatomical landmarks. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 54 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2006to Feb 2008
- Phase
- Interventional
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Full term pregnant patients requesting labor epidurals
- Pre-pregnancy BMI greater than 30
Who cannot join
- Known spinal deformities
- Previous back instrumentation
- Pre-pregnancy BMI less than 30
Trial locations and contacts
1 site in 1 country.
About this study
The efficacy of an epidural depends mainly on accurate placement of the catheter in the epidural space. Therefore, identification of the epidural space is the most vital part of the procedure. Obese patients represent the most challenging group for the identification of anatomical landmarks. With the use of ultrasound, we can visualize the images of the anatomical structures in the back. Some anesthesiologists believe ultrasound can help in the placement of an epidural, and routinely use it to assist in determining needle entry point in your back as well as estimating the depth at which the epidural space will be found. Our hypothesis is that the use of lumbar spine ultrasound imaging will accurately determine the epidural space depth and the epidural insertion point in obese patients.
Read the detailed description
Recent technical advances, especially the evolution of ultrasound technology, have helped to some extent in circumventing some of the limitations of epidural anesthesia. The efficacy of an epidural depends mainly on accurate placement of the catheter in the epidural space. Therefore, identification of the epidural space is the most vital part of the procedure. Obese patients represent are the most challenging group for the identification of anatomical landmarks, it is important to determine if ultrasound imaging is a useful technique in this population.
All the patients will undergo ultrasound imaging of the lumbar spine just before epidural insertion. Ultrasound imaging will be performed by one of the investigators. A different anesthesiologist will perform the epidural procedure based on the US information provided by the investigator. The investigator will provide information to the epidural performer on the insertion point, the angle of needle insertion and safe approximate distance before reaching the epidural space to facilitate the epidural performance. To maintain blinding and to prevent performer bias, the exact depth of the epidural space from skin, as seen on the ultrasound will not be disclosed. The investigator, with the aid of an in-built caliper, will measure this distance at a later time before saving the image.
The results of this study are expected to determine the clinical reliability of ultrasound imaging in visualizing the anatomical structures relevant to the technical performance of epidural analgesia in the obese population. Since technical difficulty in performing epidurals is more commonly encountered in obese patients, ultrasound visualization would improve the overall success of the technique by predicting the depth of the epidural needle to be inserted. In turn, the complication rate would be minimized.
- Conditions
- Obesity
- Being tested
- Ultrasound
- Keywords
- Ultrasound, Obesity, Needle Depth
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundProcedure or surgery
ultrasound scan of the lumbar spine with 2-5 MHz curved array probe
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Epidural Depth
Measured: 30 minutes
Secondary outcomes (4)
Accuracy of needle angle, re-insertion of the epidural needle in the same interspace or different interspace
Measured: 30 minutes
Correlation between BMI and skin thickness
Measured: analysis at study end, approximately 1 year
Correlation between BMI and needle depth
Measured: analysis at study end, approximately 1 year
Duration of ultrasound scanning
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2007 (estimated)
- Study startOct 2006
- Primary completionFeb 2008
- Study completionFeb 2008
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Mrinalini Balki, MD, Principal investigator, Department of Anesthesia and Pain Management, Mount Sinai Hospital, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00439998
- Sponsor's protocol ID
- 06-03
- Other IDs
- 06-0218-E
- Status last verified
- Jul 2009
- First submitted
- 22 Feb 2007
- Last updated
- 30 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Imaging For Facilitating Labour Epidurals in Obese Parturients
- ClinicalTrials.gov ID
- NCT00439998
- Acronym / sponsor ID
- 06-03
- Conditions
- Obesity
- Keywords
- Ultrasound, Obesity, Needle Depth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 26 Feb 2007 (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 efficacy of an epidural depends mainly on accurate placement of the catheter in the epidural space. Therefore, identification of the epidural space is the most vital part of the procedure. Obese patients represent the most challenging group for the identification of anatomical landmarks. With the use of ultrasound, we can visualize the images of the anatomical structures in the back. Some anesthesiologists believe ultrasound can help in the placement of an epidural, and routinely use it to assist in determining needle entry point in your back as well as estimating the depth at which the epidural space will be found. Our hypothesis is that the use of lumbar spine ultrasound imaging will accurately determine the epidural space depth and the epidural insertion point in obese patients.
Detailed description
Recent technical advances, especially the evolution of ultrasound technology, have helped to some extent in circumventing some of the limitations of epidural anesthesia. The efficacy of an epidural depends mainly on accurate placement of the catheter in the epidural space. Therefore, identification of the epidural space is the most vital part of the procedure. Obese patients represent are the most challenging group for the identification of anatomical landmarks, it is important to determine if ultrasound imaging is a useful technique in this population.
All the patients will undergo ultrasound imaging of the lumbar spine just before epidural insertion. Ultrasound imaging will be performed by one of the investigators. A different anesthesiologist will perform the epidural procedure based on the US information provided by the investigator. The investigator will provide information to the epidural performer on the insertion point, the angle of needle insertion and safe approximate distance before reaching the epidural space to facilitate the epidural performance. To maintain blinding and to prevent performer bias, the exact depth of the epidural space from skin, as seen on the ultrasound will not be disclosed. The investigator, with the aid of an in-built caliper, will measure this distance at a later time before saving the image.
The results of this study are expected to determine the clinical reliability of ultrasound imaging in visualizing the anatomical structures relevant to the technical performance of epidural analgesia in the obese population. Since technical difficulty in performing epidurals is more commonly encountered in obese patients, ultrasound visualization would improve the overall success of the technique by predicting the depth of the epidural needle to be inserted. In turn, the complication rate would be minimized.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Full term pregnant patients requesting labor epidurals
- Pre-pregnancy BMI greater than 30
Key exclusion criteria (3 listed)
- Known spinal deformities
- Previous back instrumentation
- Pre-pregnancy BMI less than 30
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 |
|---|---|---|
| Ultrasoundultrasound scan of the lumbar spine with 2-5 MHz curved array probe | Procedure or surgery | – |
Primary outcome
Accuracy of Epidural Depth
Time frame: 30 minutes
4 secondary outcomes
Accuracy of needle angle, re-insertion of the epidural needle in the same interspace or different interspace
Time frame: 30 minutes
Correlation between BMI and skin thickness
Time frame: analysis at study end, approximately 1 year
Correlation between BMI and needle depth
Time frame: analysis at study end, approximately 1 year
Duration of ultrasound scanning
Time frame: 30 minutes
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 30 Jul 2009.
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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.
Mrinalini Balki, MD principal investigator
Department of Anesthesia and Pain Management, Mount Sinai Hospital, University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Obesity, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
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 2 inclusion and 3 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 30 Jul 2009. 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 Canada. 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?
Accuracy of Epidural Depth (time frame: 30 minutes). 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 2009.