Traumatic Lumbar Puncture
Conditions
Keywords
Ultrasound, Lumbar Puncture, Spinal Tap, Pediatric, Infant, Bedside Ultrasonography
Brief summary
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.
Detailed 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.
Interventions
DEVICEMindray M7 Ultrasound
Patient will receive a bedside ultrasound exam of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap
PROCEDUREBedside Ultrasound-Assisted Site Marking
Patient will receive a bedside ultrasound-assisted site marking of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap using Mindray M7 Ultrasound.
PROCEDURERoutine lumbar puncture
Lumbar puncture will be performed per routine standard of care
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
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Successful First Attempt Lumbar Punctures in the Ultrasound-assisted Group as Compared to the Non-ultrasound Assisted Group | 30 minutes | First attempt success in ultrasound-assisted group compared to first attempt success in non-ultrasound assisted group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Overall Success of Lumbar Punctures in the Ultrasound-assisted Group Versus the Non-ultrasound-assisted Group | 30 minutes | Overall success of lumbar punctures (within 3 attempts) in the non-ultrasound-assisted group compared to the ultrasound-assisted group |
| Length of Hospitalization in Ultrasound-assisted Lumbar Puncture Patients Versus Non-ultrasound-assisted Patients | Participants will be followed for the duration of the hospital stay, an expected average of 2 days | If a lumbar puncture is not successful, this may lead to a longer hospitalization than necessary until a lumbar puncture can be completed (with interventional radiology or other resources). According to our hypothesis, we believe that ultrasound assistance will increase the proportion of successful lumbar punctures, and therefore, decrease the length of unnecessary hospitalization. |
| Length of Antibiotic Use in Ultrasound-assisted Lumbar Puncture Patients Versus Non-ultrasound-assisted Patients | Participants will be followed until discontinuation of antibiotics, an expected average of 2 days | If a lumbar puncture is not successful, this may lead to unnecessary (prophylactic) antibiotic use until a lumbar puncture can be completed (with interventional radiology or other resources) to rule out meningitis. According to our hypothesis, we believe that ultrasound assistance will increase the proportion of successful lumbar punctures, and therefore, decrease the length of unnecessary antibiotics. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| US-Assisted Site Marking for LP Mindray M7 Ultrasound marking
Bedside Ultrasound-Assisted Site Marking: Patient will receive a bedside ultrasound-assisted site marking of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap using Mindray M7 Ultrasound.
Mindray M7 Ultrasound: Patient will receive a bedside ultrasound exam of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap | 64 |
| Routine Lumbar Puncture 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
Routine lumbar puncture: Lumbar puncture will be performed per routine standard of care | 64 |
| Total | 128 |
Baseline characteristics
| Characteristic | Routine Lumbar Puncture | US-Assisted Site Marking for LP | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 64 Participants | 64 Participants | 128 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 | 29 days | 24 days | 26 days |
| Region of Enrollment United States | 64 participants | 64 participants | 128 participants |
| Sex: Female, Male Female | 34 Participants | 19 Participants | 53 Participants |
| Sex: Female, Male Male | 30 Participants | 45 Participants | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 64 | 0 / 64 |
| other Total, other adverse events | 0 / 64 | 0 / 64 |
| serious Total, serious adverse events | 0 / 64 | 0 / 64 |
Outcome results
Primary
Percentage of Successful First Attempt Lumbar Punctures in the Ultrasound-assisted Group as Compared to the Non-ultrasound Assisted Group
First attempt success in ultrasound-assisted group compared to first attempt success in non-ultrasound assisted group
Time frame: 30 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| US-Assisted Site Marking for LP | Percentage of Successful First Attempt Lumbar Punctures in the Ultrasound-assisted Group as Compared to the Non-ultrasound Assisted Group | 58 percent success |
| Routine Lumbar Puncture | Percentage of Successful First Attempt Lumbar Punctures in the Ultrasound-assisted Group as Compared to the Non-ultrasound Assisted Group | 31 percent success |
Secondary
Length of Antibiotic Use in Ultrasound-assisted Lumbar Puncture Patients Versus Non-ultrasound-assisted Patients
If a lumbar puncture is not successful, this may lead to unnecessary (prophylactic) antibiotic use until a lumbar puncture can be completed (with interventional radiology or other resources) to rule out meningitis. According to our hypothesis, we believe that ultrasound assistance will increase the proportion of successful lumbar punctures, and therefore, decrease the length of unnecessary antibiotics.
Time frame: Participants will be followed until discontinuation of antibiotics, an expected average of 2 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| US-Assisted Site Marking for LP | Length of Antibiotic Use in Ultrasound-assisted Lumbar Puncture Patients Versus Non-ultrasound-assisted Patients | 26.8 hours |
| Routine Lumbar Puncture | Length of Antibiotic Use in Ultrasound-assisted Lumbar Puncture Patients Versus Non-ultrasound-assisted Patients | 25 hours |
Secondary
Length of Hospitalization in Ultrasound-assisted Lumbar Puncture Patients Versus Non-ultrasound-assisted Patients
If a lumbar puncture is not successful, this may lead to a longer hospitalization than necessary until a lumbar puncture can be completed (with interventional radiology or other resources). According to our hypothesis, we believe that ultrasound assistance will increase the proportion of successful lumbar punctures, and therefore, decrease the length of unnecessary hospitalization.
Time frame: Participants will be followed for the duration of the hospital stay, an expected average of 2 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| US-Assisted Site Marking for LP | Length of Hospitalization in Ultrasound-assisted Lumbar Puncture Patients Versus Non-ultrasound-assisted Patients | 46 hours |
| Routine Lumbar Puncture | Length of Hospitalization in Ultrasound-assisted Lumbar Puncture Patients Versus Non-ultrasound-assisted Patients | 48.1 hours |
Secondary
Percentage of Overall Success of Lumbar Punctures in the Ultrasound-assisted Group Versus the Non-ultrasound-assisted Group
Overall success of lumbar punctures (within 3 attempts) in the non-ultrasound-assisted group compared to the ultrasound-assisted group
Time frame: 30 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| US-Assisted Site Marking for LP | Percentage of Overall Success of Lumbar Punctures in the Ultrasound-assisted Group Versus the Non-ultrasound-assisted Group | 75 percentage success |
| Routine Lumbar Puncture | Percentage of Overall Success of Lumbar Punctures in the Ultrasound-assisted Group Versus the Non-ultrasound-assisted Group | 44 percentage success |