Utility of Ultrasound-Guided Site Marking in Pediatric Lumbar Punctures

NCT04828746 | Unknown DMC

• 1 other identifier: IRB-20-800
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The standard way to identify landmarks in the spine before inserting a needle for a lumbar puncture is to feel by touch. The purpose of this research is to determine if doing an ultrasound to identify landmarks before performing a lumbar puncture will improve the first-time success rate of the needle insertion in pediatric patients.

Conditions

Ultrasound Therapy; Complications

Outcome Measures

Primary Outcomes (1)

• Attempts

  Number of attempts required for successful LP and subsequent specimen collection

  Through study completion, anticipated average of 1 year

Secondary Outcomes (5)

• Age

  Through study completion, anticipated average of 1 year

• BMI

  Through study completion, anticipated average of 1 year

• LP Position

  Through study completion, anticipated average of 1 year

• Quality of CSF sample based on grading criteria

  Through study completion, anticipated average of 1 year

• Time required for procedure completion

  Through study completion, anticipated average of 1 year

Study Arms (2)

Control

NO INTERVENTION

Patients who will undergo lumbar puncture without pre-procedural ultrasound-guided skin marking

Experimental

EXPERIMENTAL

Patients who will undergo lumbar puncture after pre-procedural ultrasound-guided skin marking

Procedure: Ultrasound Guided Skin Marking

Interventions

Ultrasound Guided Skin Marking PROCEDURE

Using ultrasound for skin marking pre-procedure

Experimental

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Birth to 17y of age
• Patient currently in Pediatric ED, Ward, or ICU
• Determined by providers caring for the patient that lumbar puncture is clinically indicated
• Parent/Legal Guardian able to give consent prior to the procedure

You may not qualify if:

• Known anatomic spinal deformity (e.g. scoliosis)
• Critical illness where emergent lumbar puncture is needed
• Patients only able to be entered in the study once per encounter
• Patients who are wards of the state or in foster care

Sponsors & Collaborators

• Carilion Clinic: lead

Study Sites (1)

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, 24014, United States

RECRUITING

Study Officials

• Rahul Pandey, MD

  Carilion Clinic Physician

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Hayes, DO

CONTACT

540-682-0259; ajhayes@carilionclinic.org

Rahul Pandey, MD

CONTACT

rkpandey@carilionclinic.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients assigned to either pre-procedural ultrasound-guided anatomy review and skin marking prior to a lumbar puncture v standard of care, palpation only guided lumbar puncture.

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 2, 2021
• Study Start: March 15, 2021
• Primary Completion: December 1, 2022
• Study Completion: March 1, 2023
• Last Updated: February 7, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)