Lumbar Puncture
Conditions
Keywords
Ultrasonography, Infant, Newborn, Lumbar puncture, Spinal puncture, Cerebrospinal fluid
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.
Interventions
OTHERPalpation 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.
DEVICEUltrasound-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.
Sponsors
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Successful First Attempt LPs | Up to 30 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Overall Success of LPs Within 2 Attempts | Up to 30 minutes | 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. Providers will have 2 attempts to complete the LP. If CSF cannot be obtained within 2 attempts, any subsequent attempt will be at the discretion of the attending neonatologist and will be performed outside this study by the care team. |
| Difference in Length of Antibiotic Exposure | Length of Hospitalization (approximately 1 month) | To determine whether bedside-ultrasound assisted LPs are associated with a decrease in the length of antibiotic exposure in patients undergoing LPs. If LP is unsuccessful, the mean length of antibiotic exposure as compared to patients with successful LPs will be compared. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJason Stoller, MD
Children's Hospital of Philadelphia
Participant flow
Pre-assignment details
91 subjects were randomized and completed 95 LPs. Two infants were randomized to one traditional LP and one ultrasound LP; two infants were randomized to traditional LP twice.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 15 Days |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 45 |
| other Total, other adverse events | 0 / 46 | 0 / 45 |
| serious Total, serious adverse events | 0 / 46 | 0 / 45 |
Outcome results
None listed