Recruiting

Observational Study

Sponsor:

Carilion Clinic

Code:

NCT04828746

Conditions

Ultrasound Therapy; Complications

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Accepted

Interventions

Ultrasound Guided Skin Marking

Study Details

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

Study ID

NCT04828746

Start date

Mar 15, 2021

Status verified date

Jan, 2022

Completion date

Mar, 2023

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

no intervention: Control

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

Interventions

Ultrasound Guided Skin Marking

Using ultrasound for skin marking pre-procedure

Primary outcome measure

  • Attempts [ Time Frame: Through study completion, anticipated average of 1 year ]

Central Contacts and Locations

Central contacts

Andrew Hayes, DO

540-682-0259ajhayes@carilionclinic.org

Rahul Pandey, MD

rkpandey@carilionclinic.org

Locations

Carilion Roanoke Memorial Hospital

Recruiting

Roanoke, Virginia, United States, 24014

Contacts

Rahul Pandey, MD

rkpandey@carilionclinic.org

More Information

Sponsor

Carilion Clinic

Last update posted

Feb 7, 2022

Last verified

Jan, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Carilion Clinic on 2022-02-07.