HealthyNCT02697747
Identification of L3-L4 Interspace in Parturients
An observational study of Healthy, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The investigators hypothesize that teaching ultrasound sonoanatomy to identify the L3-L4 interspace will improve resident's long term skill to correctly identify the interspace as compared to palpation alone. Read more about this study
- Who is it for?
- Ages 12 to 65 years, women only
- Conditions the study is for
- Healthy
- What is being tested?
- Education
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Aug 2021
- 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 12 to 65 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pregnant female patients.
Who may be able to join
- term gestation (at least 38 weeks gestation)
Who cannot join
- Prior back surgery
- Previously diagnosed skeletal deformities such as scoliosis
- BMI greater than 40
- Height less than 60 inches
- Patient discomfort requiring immediate analgesia
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
The investigators hypothesize that teaching ultrasound sonoanatomy to identify the L3-L4 interspace will improve resident's long term skill to correctly identify the interspace as compared to palpation alone.
Read the detailed description
This will be an observational education based study to improve anesthesiology resident's ability to correctly identify the L3-L4 interspace. Residents who agree to participate in the study will be trained using ultrasound to identify the L3-L4 interspace during their rotation on the obstetric anesthesia service. Training will include using the ultrasound to correlate the surface palpation with the underlying structures. This will be supplemented with teaching videos and literature. The training will be performed for the first three weeks of the four week rotation.
After undergoing this training program, during the fourth week of the rotation, the residents will be asked to perform palpation identification of the L3-L4 interspace on parturients. Ultrasound will be used to assess the accuracy of the identified level. These assessments will repeated at six and 12 months to assess whether the skill has been retained.
- Conditions
- Healthy
- Being tested
- Education
- Keywords
- Ultrasound, Palpation, Analgesia, Epidural
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
Educational intervention in the use of ultrasound to identify landmarks
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound education | Training in the use of ultrasound to identify the L3-L4 interspace Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy measured as percentage of cases where the L3-4 vertebral interspace is identified correctly
Percentage of cases where the L3-4 vertebral interspace is identified correctly
Measured: 1 month
Secondary outcomes (1)
Durability measured as percentage of cases where the L3-4 vertebral interspace is identified correctly
percentage of cases where the L3-4 interspace is identified correctly at 6 months and again at 12 months
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startNov 2015
- Primary completionDec 2020
- Study completionAug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phillip Hess, Beth Israel Deaconess Medical Center
- Investigators
- Philip E Hess, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02697747
- Sponsor's protocol ID
- 2015P000225
- Status last verified
- Sep 2021
- First submitted
- 16 Nov 2015
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of L3-L4 Interspace in Parturients
- ClinicalTrials.gov ID
- NCT02697747
- Acronym / sponsor ID
- 2015P000225
- Conditions
- Healthy
- Keywords
- Ultrasound, Palpation, Analgesia, Epidural
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Dec 2020 (actual)
- Study completion
- Aug 2021 (actual)
- First posted
- 3 Mar 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 investigators hypothesize that teaching ultrasound sonoanatomy to identify the L3-L4 interspace will improve resident's long term skill to correctly identify the interspace as compared to palpation alone.
Detailed description
This will be an observational education based study to improve anesthesiology resident's ability to correctly identify the L3-L4 interspace. Residents who agree to participate in the study will be trained using ultrasound to identify the L3-L4 interspace during their rotation on the obstetric anesthesia service. Training will include using the ultrasound to correlate the surface palpation with the underlying structures. This will be supplemented with teaching videos and literature. The training will be performed for the first three weeks of the four week rotation.
After undergoing this training program, during the fourth week of the rotation, the residents will be asked to perform palpation identification of the L3-L4 interspace on parturients. Ultrasound will be used to assess the accuracy of the identified level. These assessments will repeated at six and 12 months to assess whether the skill has been retained.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound education | – | Other: EducationTraining in the use of ultrasound to identify the L3-L4 interspace |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant female patients.
Key inclusion criteria (1 listed)
- term gestation (at least 38 weeks gestation)
Key exclusion criteria (5 listed)
- Prior back surgery
- Previously diagnosed skeletal deformities such as scoliosis
- BMI greater than 40
- Height less than 60 inches
- Patient discomfort requiring immediate analgesia
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 |
|---|---|---|
| EducationEducational intervention in the use of ultrasound to identify landmarks | Other | Ultrasound education |
Primary outcome
Accuracy measured as percentage of cases where the L3-4 vertebral interspace is identified correctly
Time frame: 1 month
Percentage of cases where the L3-4 vertebral interspace is identified correctly
1 secondary outcome
Durability measured as percentage of cases where the L3-4 vertebral interspace is identified correctly
Time frame: 6 months and 12 months
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 1 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Philip E Hess, MD principal investigator
Beth Israel Deaconess Medical Center
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 Healthy, run by Beth Israel Deaconess Medical Center at 1 site in United States.
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 5 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 1 Oct 2021. 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 United States. 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 measured as percentage of cases where the L3-4 vertebral interspace is identified correctly (time frame: 1 month). 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 1 Oct 2021.