Ultrasound Assisted Lumbar Puncture in the Neonate

NCT ID: NCT02918149

Last Updated: 2023-07-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2024-06-30

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.

Detailed Description

Obtaining cerebrospinal fluid (CSF) through a lumbar puncture (LP) is an essential procedure in the neonatal/infant intensive care unit (N/IICU) for establishing diagnosis and determining treatment. The traditional technique for performing an LP involves palpation of anatomic landmarks followed by a "blind" stick of the appropriate inter-spinous process space. This technique has a failure rate (defined as the inability to obtain cerebrospinal fluid or obtaining a traumatic puncture) of 15-50%.

Bedside ultrasonography possesses the ability to visualize the anatomic landmarks, including the subarachnoid space. In the adult literature, ultrasound has been shown to reduce the LP failure rate. Its utility has also been shown to significantly improve success rates and accuracy in epidural needle placement in neonates and children undergoing regional anesthesia. Increasing the proportion of successful LPs in the N/IICU could significantly reduce patient/family discomfort, sedation exposure, off unit travel, additional interventional procedures and antibiotic use. However, research on the utility of bedside ultrasound assisted LPs by clinicians working in an N/IICU is lacking.

This is a prospective randomized controlled trial. Eligible subjects will be randomized to undergo LP (performed as part of their standard of care) with ultrasound assisted method or traditional landmark method.

Primary Objective:

-To determine if bedside ultrasound-assisted LP, performed by N/IICU clinicians on neonates and infants aged ≤6 months, increases the proportion of successful first attempt non-traumatic LPs when compared to a traditional landmark palpation technique.

Secondary Objectives:

• To determine if bedside-ultrasound assisted LPs increases the proportion of overall successful non-traumatic LPs within 2 attempts.
• To determine if bedside-ultrasound assisted LPs is associated with a decrease in the length of antibiotic exposure in patients undergoing LPs.

Conditions

Lumbar Puncture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Palpation Landmark Technique LP

Traditional landmark palpation technique will be used to perform LP

Group Type: OTHER

Palpation Landmark Technique

Intervention Type: OTHER

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.

Ultrasound-Assisted Technique LP

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

Group Type: EXPERIMENTAL

Ultrasound-Assisted Technique LP

Intervention Type: DEVICE

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.

Interventions

Palpation Landmark Technique

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.

Intervention Type: OTHER

Ultrasound-Assisted Technique LP

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.

Intervention Type: DEVICE

Other Intervention Names

Non-Ultrasound Assisted LP; Phillips CX50

Eligibility Criteria

Inclusion Criteria

1. Neonates and infants aged ≤6 months

2. Clinical indication for a lumbar puncture (LP), as determined by the clinical team

3. Availability of study personnel to perform bedside ultrasound

Exclusion Criteria

1. Known spinal cord abnormality (for e.g., tethered cord, spina bifida)

2. Presence of skin and soft tissue infection at insertion site

3. Recent failed LP traumatic LP attempts within the preceding 48 hours

4. Recent diagnosis of intraventricular hemorrhage, within the preceding 7 days

5. Clinically unstable patient, as determined by the clinical team

6. Eligible patients on the resident care team

• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason Stoller, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

16-012757

Identifier Type: -

Identifier Source: org_study_id