HeadacheNCT00317382
Does Static Ultrasound-Preview Reduce the Incidence of Difficult Lumbar Puncture?
A study testing Ultrasound in people with Headache and Meningitis, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
Trial summary
Does the use of ultrasound facilitate a lumbar puncture by reducing the number of difficult and traumatic lumbar punctures? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Headache, Meningitis, Subarachnoid Hemorrhage
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Oct 2005
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18
- Clinical need for lumbar puncture
- Unable to visualize spine in position for the lumbar puncture
Who cannot join
- Able to visualize the spinous processes
Trial locations and contacts
1 site in 1 country.
United States1 site
St.Luke's-Roosevelt Hospital
New York, New York, 10025
About this study
Official title: Does Static Ultrasound-Preview Reduce the Incidence of Traumatic and/or Difficult Lumbar Puncture? A Randomized Control Trial
Does the use of ultrasound facilitate a lumbar puncture by reducing the number of difficult and traumatic lumbar punctures?
Read the detailed description
This is a controlled trial randomizing lumbar puncture patients to groups utilizing ultrasound to preview the bony structures of the spine versus using standard palpation technique. The goal is to determine the helpfulness of ultrasound in performing lumbar punctures (to reduce difficult and traumatic lumbar punctures) among patients whose spines cannot be easily visualized.
- Conditions
- Headache, Meningitis, Subarachnoid Hemorrhage
- Being tested
- Ultrasound
- Keywords
- lumbar puncture, headache, traumatic tap
- Medical subject headings
- Headache, Meningitis, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Ultrasound used to visualize spine to determine best location for lumbar puncture.
| Study group | Role | What they receive |
|---|---|---|
| No Ultrasound | No intervention | Standard LP without ultrasound use |
| Ultrasound Use | Experimental | Ultrasound used to assess spine and best location for lumbar puncture. Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 or more needle sticks to successfully complete lumbar puncture
Measured: We collect the data immediately
Greater than 400 red blood cells in the cerebral spinal fluid
Measured: Data is obtained within 1 hour when the lab reports the results of the CSF analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2006 (estimated)
- Study startDec 2004
- Primary completionOct 2005
- Study completionOct 2005
Why it stopped: We could not get physicians in the ED to enroll patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Investigators
- Kaushal Shah, MD, Principal investigator, St. Luke's-Roosevelt Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00317382
- Sponsor's protocol ID
- 03-148
- Status last verified
- Feb 2015
- First submitted
- 20 Apr 2006
- Last updated
- 19 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Static Ultrasound-Preview Reduce the Incidence of Traumatic and/or Difficult Lumbar Puncture? A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT00317382
- Acronym / sponsor ID
- 03-148
- Conditions
- Headache, Meningitis, Subarachnoid Hemorrhage
- Keywords
- lumbar puncture, headache, traumatic tap
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We could not get physicians in the ED to enroll patients.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Study start
- Dec 2004
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 24 Apr 2006 (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.
Does the use of ultrasound facilitate a lumbar puncture by reducing the number of difficult and traumatic lumbar punctures?
Detailed description
This is a controlled trial randomizing lumbar puncture patients to groups utilizing ultrasound to preview the bony structures of the spine versus using standard palpation technique. The goal is to determine the helpfulness of ultrasound in performing lumbar punctures (to reduce difficult and traumatic lumbar punctures) among patients whose spines cannot be easily visualized.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Ultrasound | No intervention | –Standard LP without ultrasound use |
| Ultrasound Use | Experimental | Device: UltrasoundUltrasound used to assess spine and best location for lumbar puncture. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age greater than 18
- Clinical need for lumbar puncture
- Unable to visualize spine in position for the lumbar puncture
Key exclusion criteria (1 listed)
- Able to visualize the spinous processes
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 used to visualize spine to determine best location for lumbar puncture. | Device | Ultrasound Use |
Primary outcome
3 or more needle sticks to successfully complete lumbar puncture
Time frame: We collect the data immediately
Greater than 400 red blood cells in the cerebral spinal fluid
Time frame: Data is obtained within 1 hour when the lab reports the results of the CSF analysis
Results and safety
The study was stopped early (reason given: We could not get physicians in the ED to enroll patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2015.
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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.
Kaushal Shah, MD principal investigator
St. Luke's-Roosevelt Hospital Center
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 Headache and Meningitis, run by St. Luke's-Roosevelt Hospital 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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 19 Feb 2015. 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 was stopped early (reason given: We could not get physicians in the ED to enroll patients.). Results are not available in the source record.
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?
3 or more needle sticks to successfully complete lumbar puncture (time frame: We collect the data immediately). 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 19 Feb 2015.