Bedside Ultrasound Assisted Pediatric Lumbar Puncture

October 2, 2024 updated by: Wake Forest University Health Sciences

Bedside Ultrasound Assisted Pediatric Lumbar Puncture--A Randomized Controlled Trial

This is a prospective, randomized study evaluating the efficacy of bedside ultrasound assisted lumbar puncture in pediatric patients

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Comparison of bedside ultrasound assisted lumbar puncture to traditional anatomical landmark approach in neonates and young infants requiring lumbar puncture

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Oak Lawn, Illinois, United States, 60453
        • Advocate Christ Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Any patient 0-12 months old requiring a lumbar puncture in the pediatric emergency department or inpatient pediatric floor is eligible to participate in the study

Exclusion Criteria:

  • previous back surgeries
  • parent/ guardian inability to understand informed consent
  • parent/guardian refusal of informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 90 days and under--Interventional
Neonates aged 90 days and under randomized to ultrasound assisted lumbar puncture
Procedure: Ultrasound assisted lumbar puncture
An investigator will perform beside ultrasound on the spinal area using a bedside ultrasound device. Attempts will be made to visualize the spinous processes and vertebral bodies in the general lumbarsacral area, as well as the presence of CSF in the thecal space below the conus medullaris, and identify the optimal location to perform the LP. This will be marked with a skin marker (If no CSF or abnormal anatomy is visualized, the LP will be advised to be postponed or cancelled). The treating physician will then proceed with the LP guided by the skin markings.
Other Names:
  • Sonosite M-Turbo ultrasound device (Bothell, WA) with a L25 linear transducer
  • or
  • Zonare Z.One device(Mountain View, CA) with a L10-5 linear array transducer,
No Intervention: 90 days and under--control
Neonates aged 90 days and under randomized to lumbar puncture using the anatomical landmark approach
Experimental: Over 90 days--Interventional
Neonates aged over 90 days randomized to ultrasound assisted lumbar puncture
Procedure: Ultrasound assisted lumbar puncture
An investigator will perform beside ultrasound on the spinal area using a bedside ultrasound device. Attempts will be made to visualize the spinous processes and vertebral bodies in the general lumbarsacral area, as well as the presence of CSF in the thecal space below the conus medullaris, and identify the optimal location to perform the LP. This will be marked with a skin marker (If no CSF or abnormal anatomy is visualized, the LP will be advised to be postponed or cancelled). The treating physician will then proceed with the LP guided by the skin markings.
Other Names:
  • Sonosite M-Turbo ultrasound device (Bothell, WA) with a L25 linear transducer
  • or
  • Zonare Z.One device(Mountain View, CA) with a L10-5 linear array transducer,
No Intervention: Over 90 days--Control
Neonates aged over 90 days randomized to lumbar puncture using the anatomical landmark approach

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Traumatic lumbar puncture
Time Frame: up to 24 hours
RBC>10,000/ mm3 on spinal fluid analysis
up to 24 hours
Unsuccessful lumbar puncture
Time Frame: average of <1hour
failure to yield enough fluid for cerebrospinal fluid cell count as indicated by operator report on data collection sheet
average of <1hour

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hospital length of stay
Time Frame: average of <7days
as reported in the subjects' medical record
average of <7days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
clinical outcome/ hospital course of the patient
Time Frame: 30days
whether there was any adverse effect/ complication due to lumbar puncture based on review of medical record
30days
number of lumbar puncture attempts
Time Frame: average of <1hour
as recorded on the data collection form
average of <1hour
time to completion of lumbar puncture
Time Frame: average of <1hour
as reported in the data collection form (measured in seconds)
average of <1hour
perception of the clinician on the usefulness of bedside ultrasound if used
Time Frame: up to 24 hours
as rated on a 1-5 Likert scale by the operator on the data collection form
up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Samuel Lam, MD, Advocate Health Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AHC 4746

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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