Bedside Ultrasound Assisted Pediatric Lumbar Puncture

Infant/ Neonate Lumbar Puncture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02193763
• Other study ID #: AHC 4746
• Status: Suspended
• Phase: N/A
• Start date: August 2009
• Est. completion date: December 2020

Study information

• Verified date: July 2019
• Source: Advocate Health Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 120
• Est. completion date: December 2020
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Months

Eligibility

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.

Related Conditions & MeSH terms

• Infant/ Neonate Lumbar Puncture
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Advocate Christ Medical Center	Oak Lawn	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Advocate Health Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	clinical outcome/ hospital course of the patient	whether there was any adverse effect/ complication due to lumbar puncture based on review of medical record	30days
Other	number of lumbar puncture attempts	as recorded on the data collection form	average of <1hour
Other	time to completion of lumbar puncture	as reported in the data collection form (measured in seconds)	average of <1hour
Other	perception of the clinician on the usefulness of bedside ultrasound if used	as rated on a 1-5 Likert scale by the operator on the data collection form	up to 24 hours
Primary	Traumatic lumbar puncture	RBC>10,000/ mm3 on spinal fluid analysis	up to 24 hours
Primary	Unsuccessful lumbar puncture	failure to yield enough fluid for cerebrospinal fluid cell count as indicated by operator report on data collection sheet	average of <1hour
Secondary	Hospital length of stay	as reported in the subjects' medical record	average of <7days