Hemorrhage Elimination During Lumbar Puncture Using Ultrasound Measurements (HELPUS)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-12
SponsorVanderbilt University Medical Center

About this trial

This is a clinical trial to determine the extent to which ultrasound-assisted lumbar puncture using a standardized procedure, including use of ultrasound to ascertain the presence of cerebrospinal fluid (CSF) at L3 - L5 and the optimal needle insertion distance, increases the acquisition rate of CSF that is interpretable for patient management.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

- Neonates and infants (< 12 months)

Hemodynamically stable

Undergoing a lumbar puncture for diagnostic testing

Disqualifiers

- Infants > 12 months and 1 day

Signs of clinical instability

Known spinal anomalies (e.g., spina bifida, meningomyelocele) or previous spinal surgery

Trial design

Design model

Parallel

Treatments tested in this trial

  • ultrasound contrast

    Device

    Ultrasound of spinal canal without contrast. We included the term "ultrasound contrast" because the choices were limited.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: UltrasoundExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Successful LP rate

Acquisition of CSF sufficient for cell count, culture and meningoencephalitis PCR panel (MEP).

Time frame
Time from lumbar puncture to results of CSF returned by lab, approximately 1 hour.

Secondary outcomes

1

Unsuccessful ultrasound attempt

Ultrasound attempt in which the ultrasound operator could not complete the study and, as a result, did not attempt to use ultrasound images to inform LP. Potential causes include but are not limited to infant fussiness, inability to maintain positioning sufficient for ultrasound, and malfunction of the ultrasound machine.

Time frame
Immediately after intervention
2

Traumatic LP rate

CSF RBC count \> 500 cells/mm, the most widely accepted definition of traumatic LP. 10-12 The rate of traumatic LPs using this definition is 35 - 47% in neonates and 22 - 26% in infants (\< 13 months).

Time frame
Time from lumbar puncture to results of CSF returned by lab, approximately 1 hour
3

Number of attempts/ Number of Fluoroscopy-guided lumbar puncture (LP)

Number of attempts required for CSF acquisition or need for fluoroscopy-guided LP

Time frame
Immediately after intervention

Other outcomes

Sponsors and contacts

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