NCT02918149

Brief Summary

Clinicians are often unable to successfully do a spinal tap. Ultrasound has been proposed as a method to improve success but it is not known if it helps. This study is designed to see if ultrasound improves the success rate.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2016

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

July 17, 2023

Status Verified

July 1, 2023

Enrollment Period

7.8 years

First QC Date

September 27, 2016

Last Update Submit

July 13, 2023

Conditions

Lumbar Puncture

Keywords

UltrasonographyInfantNewbornLumbar punctureSpinal punctureCerebrospinal fluid

Outcome Measures

Primary Outcomes (1)

  • Proportion of successful first attempt LPs

    The proportion of successful first attempt LPs (defined as obtainment of CSF and non-traumatic LP) for patients in the ultrasound-assisted group compared to the traditional landmark palpation group.

    Up to 30 minutes

Secondary Outcomes (2)

  • Proportion of overall success of LPs within 2 attempts

    Up to 30 minutes

  • Difference in length of antibiotic exposure

    Length of Hospitalization (approximately 1 month)

Study Arms (2)

Palpation Landmark Technique LP

OTHER

Traditional landmark palpation technique will be used to perform LP

Other: Palpation Landmark Technique

Ultrasound-Assisted Technique LP

EXPERIMENTAL

Bedside ultrasonography exam will be used for identification of anatomic landmarks before performing LP

Device: Ultrasound-Assisted Technique LP

Interventions

Palpation Landmark TechniqueOTHER

Clinician will follow routine palpation landmark technique procedure for LP, such as identification of anatomic landmarks by palpation (i.e., superior borders of the posterior iliac crest lies in parallel with L4 spinous process). Palpation will be followed by "blind" stick of the appropriate inter-spinous process space. The study member will have 2 attempts to complete the LP. A "successful" attempt is obtaining cerebrospinal fluid.

Also known as: Non-Ultrasound Assisted LP
Palpation Landmark Technique LP
Ultrasound-Assisted Technique LPDEVICE

Clinician will use an ultrasound-assisted technique to perform the LP. The Phillips CX50 ultrasound machine is an FDA approved device and will be used in accordance with its approved labeling. Spinal ultrasound will be performed using a linear high-frequency transducer to locate and mark the termination of the conus medullaris, the narrowing of the spinal canal, and the midline to delineate a "safe zone". The study team member will have 2 attempts to complete the LP. A "successful" attempt is obtaining cerebrospinal fluid.

Also known as: Phillips CX50
Ultrasound-Assisted Technique LP

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Neonates and infants aged ≤6 months
  • Clinical indication for a lumbar puncture (LP), as determined by the clinical team
  • Availability of study personnel to perform bedside ultrasound

You may not qualify if:

  • Known spinal cord abnormality (for e.g., tethered cord, spina bifida)
  • Presence of skin and soft tissue infection at insertion site
  • Recent failed LP traumatic LP attempts within the preceding 48 hours
  • Recent diagnosis of intraventricular hemorrhage, within the preceding 7 days
  • Clinically unstable patient, as determined by the clinical team
  • Eligible patients on the resident care team

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

  • Jason Stoller, MD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 27, 2016

First Posted

September 28, 2016

Study Start

September 1, 2016

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

July 17, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)