The Effect of Bedside Ultrasound Assistance on the Proportion of Successful Infant Spinal Taps

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Traumatic Lumbar Puncture

Treatments: Device: Mindray M7 Ultrasound; Procedure: Bedside Ultrasound-Assisted Site Marking; Procedure: Routine lumbar puncture

Study type: Interventional

Funder types: Other

Identifiers

NCT02133066

13-010667

Details and patient eligibility

About

The reported rate of unsuccessful spinal taps in children, especially young infants, is high. Our hypothesis is that ultrasound assistance can improve the success rate of spinal taps.

Full description

The reported rate of unsuccessful spinal taps in children is high. At the Children's Hospital of Philadelphia (CHOP), quality improvement data demonstrates a failure rate of ~40-50%. Research has shown that bedside ultrasound can improve visualization and improve the success rate of spinal taps. Increasing the proportion of successful spinal taps in the emergency department could significantly reduce the rate of unnecessary hospitalizations, additional interventional procedures and antibiotic use. Our objective is to determine if bedside ultrasound-assisted site marking will increase the proportion of first attempt successful spinal taps. This will be a prospective, randomized controlled study that will take place over the course of 18 months with the goal to recruit a sample of approximately 128 patients. We will recruit subjects from the CHOP Emergency Department. The patients will be randomized into an ultrasound-assisted group versus a non-ultrasound-assisted group. Our hypothesis is that bedside ultrasound-assisted site marking will increase the number of successful spinal taps.

Enrollment: 128 patients

Sex: All

Ages: Under 6 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Less than or equal to six months of age
• Plan for diagnostic or therapeutic lumbar puncture as per front line clinician
• Availability of a study sonographer to perform bedside ultrasound

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 2 patient groups, including a placebo group

US-Assisted site marking for Lumbar Punctures (LP)

Active Comparator group

Description:

Mindray M7 Ultrasound marking

Treatment:

Procedure: Bedside Ultrasound-Assisted Site Marking

Device: Mindray M7 Ultrasound

Routine lumbar puncture

Placebo Comparator group

Description:

These patients will receive no ultrasound-assisted site marking prior to lumbar puncture; The patients will simply have a "standard-of-care" spinal tap performed by the clinician

Treatment:

Procedure: Routine lumbar puncture