Anesthesia, LocalNCT04757805
Accuracy of Manual Palpation vs Ultrasound for Spinal Anesthesia
A study testing Ultrasound in people with Anesthesia, Local and Infant Conditions, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
Although the current standard for lumbar puncture and spinal anesthesia is the use of manual palpation of surface landmarks to identify the correct interspace, performance of the procedure at too high of a level may increase the incidence of adverse effects. Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Anesthesia, Local, Infant Conditions
- What is being tested?
- Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2021to 21 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients less than 1 year of age scheduled for spinal anesthesia for elective lower abdominal, urologic, or lower extremity surgery at Nationwide Children's Hospital
Who cannot join
- Parents unwilling for their children to undergo spinal anesthesia for surgery.
- Children with known spinal anomalies including sacral dimple.
- Children with coagulation abnormalities or receiving anticoagulation which precludes the use of spinal anesthesia.
- Children with superficial or deep infections over the spine which precludes the use of spinal anesthesia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Assessment of the Accuracy of the Manual Palpation of Surface Landmarks Versus Ultrasound for Identification of the Correct Intervertebral Space for Spinal Anesthesia in Children Less Than 1 Year of Age
Although the current standard for lumbar puncture and spinal anesthesia is the use of manual palpation of surface landmarks to identify the correct interspace, performance of the procedure at too high of a level may increase the incidence of adverse effects. The current study will evaluate the efficacy of ultrasound in identifying the correct intervertebral space for lumbar puncture thereby improving the safety of the procedure.
- Conditions
- Anesthesia, Local, Infant Conditions
- Being tested
- Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
Ultrasound to locate the appropriate lumbar interspace to perform spinal anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Spinal anesthesia | Experimental | Infants receiving spinal anesthesia for standard of care procedure Receives: Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intended Interspace
The vertebral interspace that the anesthesia provider believes that they had marked \& identified by manual palpation
Measured: Immediately prior to spinal anesthesia
Actual Interspace of Provider's Mark
The actual vertebral interspace that the anesthesia provider marked \& identified, as verified by ultrasound.
Measured: Immediately prior to spinal anesthesia
Secondary outcomes (3)
Level of Conus Medullaris - Sitting
Assessing the level of the conus medullaris by ultrasound in the sitting position.
Measured: Immediately prior to spinal anesthesia
Time to Mark
The amount of time if took for the anesthesia provider to manually palpate and mark the desired interspace.
Measured: Immediately prior to spinal anesthesia
Time to Conduct Ultrasound
The amount of time it took for the investigator to identify the actual space that the provider marked using ultrasound.
Measured: Immediately prior to spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start6 May 2021
- Primary completion21 Mar 2022
- Study completion21 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giorgio Veneziano, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757805
- Sponsor's protocol ID
- STUDY00000558
- Status last verified
- Jan 2023
- First submitted
- 12 Feb 2021
- Last updated
- 26 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Accuracy of the Manual Palpation of Surface Landmarks Versus Ultrasound for Identification of the Correct Intervertebral Space for Spinal Anesthesia in Children Less Than 1 Year of Age
- ClinicalTrials.gov ID
- NCT04757805
- Acronym / sponsor ID
- STUDY00000558
- Conditions
- Anesthesia, Local, Infant Conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- 6 May 2021 (actual)
- Primary completion
- 21 Mar 2022 (actual)
- Study completion
- 21 Mar 2022 (actual)
- First posted
- 17 Feb 2021 (actual)
- Results
- Posted 15 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although the current standard for lumbar puncture and spinal anesthesia is the use of manual palpation of surface landmarks to identify the correct interspace, performance of the procedure at too high of a level may increase the incidence of adverse effects. The current study will evaluate the efficacy of ultrasound in identifying the correct intervertebral space for lumbar puncture thereby improving the safety of the procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal anesthesia | Experimental | Diagnostic Test: UltrasoundInfants receiving spinal anesthesia for standard of care procedure |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients less than 1 year of age scheduled for spinal anesthesia for elective lower abdominal, urologic, or lower extremity surgery at Nationwide Children's Hospital
Key exclusion criteria (4 listed)
- Parents unwilling for their children to undergo spinal anesthesia for surgery.
- Children with known spinal anomalies including sacral dimple.
- Children with coagulation abnormalities or receiving anticoagulation which precludes the use of spinal anesthesia.
- Children with superficial or deep infections over the spine which precludes the use of spinal anesthesia.
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 to locate the appropriate lumbar interspace to perform spinal anesthesia. | Diagnostic test | Spinal anesthesia |
Primary outcome
Intended Interspace
Time frame: Immediately prior to spinal anesthesia
The vertebral interspace that the anesthesia provider believes that they had marked \& identified by manual palpation
Actual Interspace of Provider's Mark
Time frame: Immediately prior to spinal anesthesia
The actual vertebral interspace that the anesthesia provider marked \& identified, as verified by ultrasound.
3 secondary outcomes
Level of Conus Medullaris - Sitting
Time frame: Immediately prior to spinal anesthesia
Time to Mark
Time frame: Immediately prior to spinal anesthesia
Time to Conduct Ultrasound
Time frame: Immediately prior to spinal anesthesia
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Anesthesia, Local and Infant Conditions, run by Nationwide Children's Hospital 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 4 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 26 Jan 2023. 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?
Yes. Results are posted in the registry (first posted 15 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Intended Interspace (time frame: Immediately prior to spinal anesthesia). The study lists 2 primary outcomes in all. 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 26 Jan 2023.