Spinal; Puncture, Complications
Conditions
Keywords
infant, lumbar puncture, patient safety, ultrasound
Brief summary
The purpose of this study is to determine if performing an ultrasound to identify the space to insert the needle before performing a lumbar puncture will improve success of the procedure and patient safety.
Detailed description
The investigators are conducting a single-center, prospective two-arm parallel group randomized clinical trial in an urban pediatric emergency department to determine if performing an ultrasound prior to lumbar puncture procedure improves success of the procedure. Patients will be block-randomized into two groups to receive procedural interspace selection via 1) standard anatomic palpation technique or 2) visualization with pre-procedural ultrasound (experimental group). 1. Standard Anatomic Palpation Technique: Participants randomized to this group will receive standard of care treatment with providers using the palpation technique to select an interspace. As variations on the palpation technique exist, the investigators will provide a standardized educational cognitive aid that clinicians can use for this approach. 2. Pre-Procedural Ultrasound: Clinicians will first use the standard palpation technique to select an interspace for ultrasound evaluation. A select group of pediatric emergency medicine attendings and fellows who have already trained to a mastery standard with the ultrasound protocol will then conduct the pre-procedural ultrasound. The clinicians performing the lumbar puncture will be provided the following information to conduct the lumbar puncture: i. Assessment for fluid at the level selected (and the number of interspaces above that have fluid without conus present) ii. Measurements of appropriate angle and depth iii. Evaluation of any overlying vasculature Post-Lumbar Puncture: After the lumbar puncture, infants randomized to both groups will receive a post-procedural ultrasound scan performed by one of the mastery trained ultrasound physicians.
Interventions
DEVICEUltrasound
Patients will receive an ultrasound prior to lumbar puncture procedure to help visualize and select spinal interspace.
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 90 Days
Healthy volunteers
Yes
Inclusion criteria
* Patient is less than 90 days old. * Patient is receiving a lumbar puncture
Exclusion criteria
* Patient is clinically unstable * Patient had a previous lumbar puncture in the past 24 hours * An outside consultant (not working in ED) is performing the LP * Patient has developmental delay or neurological impairment * There is no legal guardian present * The legal guardians speak neither English nor Spanish * There is no ultrasound personnel available to enroll
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lumbar Puncture Success - Composite Score Including Lab Results and Reported Attempts | Outcome measured on the same day of the procedure | Our primary outcome of the clinical trial is binary, success or failure of lumbar puncture. Success is defined as obtaining a sample of cerebrospinal fluid on the first attempt that has a red blood cell count of \<1000 red blood cells per high-powered field. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Attempts- Per Direct Observation | Outcome measured at the time of the procedure (same day) | Defined as the number of times a lumbar puncture needle is removed from skin and reinserted or a new needle is inserted. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Anatomic Palpation Technique Participants randomized to this group will receive standard of care treatment with providers using the palpation technique to select an interspace to perform lumbar puncture. | 40 |
| Pre-Procedural Ultrasound Participants randomized to this group will receive an ultrasound of the interspace selected via the palpation method prior to performance of the lumbar puncture to determine measurements of appropriate angle and depth and evaluation of any overlying vasculature.
Ultrasound: Patients will receive an ultrasound prior to lumbar puncture procedure to help visualize and select spinal interspace. | 41 |
| Total | 81 |
Baseline characteristics
| Characteristic | Standard Anatomic Palpation Technique | Pre-Procedural Ultrasound | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 40 Participants | 41 Participants | 81 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 25.4 days STANDARD_DEVIATION 19.4 | 29.9 days STANDARD_DEVIATION 19.3 | 27.6 days |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 40 participants | 41 participants | 81 participants |
| Sex: Female, Male Female | — | — | 0 Participants |
| Sex: Female, Male Male | — | — | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 38 |
| other Total, other adverse events | 0 / 40 | 0 / 38 |
| serious Total, serious adverse events | 0 / 40 | 0 / 38 |
Outcome results
Primary
Lumbar Puncture Success - Composite Score Including Lab Results and Reported Attempts
Our primary outcome of the clinical trial is binary, success or failure of lumbar puncture. Success is defined as obtaining a sample of cerebrospinal fluid on the first attempt that has a red blood cell count of \<1000 red blood cells per high-powered field.
Time frame: Outcome measured on the same day of the procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Anatomic Palpation Technique | Lumbar Puncture Success - Composite Score Including Lab Results and Reported Attempts | 18 Participants |
| Pre-Procedural Ultrasound | Lumbar Puncture Success - Composite Score Including Lab Results and Reported Attempts | 19 Participants |
Secondary
Number of Attempts- Per Direct Observation
Defined as the number of times a lumbar puncture needle is removed from skin and reinserted or a new needle is inserted.
Time frame: Outcome measured at the time of the procedure (same day)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Anatomic Palpation Technique | Number of Attempts- Per Direct Observation | 2 number of attempts |
| Pre-Procedural Ultrasound | Number of Attempts- Per Direct Observation | 2 number of attempts |