Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06584864
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
Bedside Ultrasound on the Effectiveness of Lumbar Puncture in Children
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Bedside Ultrasound on the Effectiveness of Lumbar Puncture in Children - Open-label Randomized Trial
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the study is to assess the influence of ultrasound examination of the lumbar spinal canal on the effectiveness of lumbar puncture An open-label randomized interventional study
Detailed Description:
Lumbar puncture is a common procedure performed in pediatric departments The most common purpose of the examination in the pediatric patient population is to exclude infectious diseases of the central nervous system meningitis and encephalitis Risk factors for traumatic or unsuccessful puncture include among others patient age less than 3 months difficulty in identifying anatomical structures by palpation lack of local anesthesia lack of experience of the person performing the procedure and patient movement during puncture The use of spinal canal ultrasonography before performing lumbar puncture brings promising benefits Ultrasound imaging can be helpful in visualizing key anatomical structures within the spinal canal and increasing the certainty of correct performance of the procedure especially in inexperienced physicians
The study objective is to assess the effect of ultrasound imaging of the lumbar spinal canal on the effectiveness of lumbar puncture
We plan to include every child 18 years old with an indication for lumbar puncture to the one of the two groups ultrasound group and standard group
Before the procedure doctors performing the lumbar puncture in both groups will complete a questionnaire regarding their previous experience In the USG group before performing the lumbar puncture one of the two researchers will perform a bedside ultrasound examination of the lumbar spinal canal
The ultrasound examination will be performed using a Lumify linear probe frequency range 4-12 MHz In the longitudinal projection the doctor will assess the sites of the spinal cord endings by marking them with a sterile marker - a horizontal line on the patients back In the same projection the doctor will designate a safe and optimal site the greatest width of the dural sac for performing a lumbar puncture by marking it with a sterile marker Additionally in the longitudinal projection the researcher will measure the depth from the skin surface to the dura mater Then in the transverse projection the doctor will confirm the absence of the spinal cord at the planned puncture site and the optimal amount of cerebrospinal fluid in the selected space This information will be passed on to the operator who will ultimately decide on the location of the lumbar puncture
In patients in the control group the lumbar puncture will be performed by palpation without additional interventions The position of the patient in both groups will depend on the preferences of the physician performing the puncture The procedure time will be measured from the moment the needle pierces the skin until the moment of obtaining cerebrospinal fluid or removing the needle if the fluid is not obtained In the research group the time of the ultrasound examination will be additionally measured
The study objective is to assess the effect of ultrasound imaging of the lumbar spinal canal on the effectiveness of lumbar puncture
We plan to include every child 18 years old with an indication for lumbar puncture to the one of the two groups ultrasound group and standard group
Before the procedure doctors performing the lumbar puncture in both groups will complete a questionnaire regarding their previous experience In the USG group before performing the lumbar puncture one of the two researchers will perform a bedside ultrasound examination of the lumbar spinal canal
The ultrasound examination will be performed using a Lumify linear probe frequency range 4-12 MHz In the longitudinal projection the doctor will assess the sites of the spinal cord endings by marking them with a sterile marker - a horizontal line on the patients back In the same projection the doctor will designate a safe and optimal site the greatest width of the dural sac for performing a lumbar puncture by marking it with a sterile marker Additionally in the longitudinal projection the researcher will measure the depth from the skin surface to the dura mater Then in the transverse projection the doctor will confirm the absence of the spinal cord at the planned puncture site and the optimal amount of cerebrospinal fluid in the selected space This information will be passed on to the operator who will ultimately decide on the location of the lumbar puncture
In patients in the control group the lumbar puncture will be performed by palpation without additional interventions The position of the patient in both groups will depend on the preferences of the physician performing the puncture The procedure time will be measured from the moment the needle pierces the skin until the moment of obtaining cerebrospinal fluid or removing the needle if the fluid is not obtained In the research group the time of the ultrasound examination will be additionally measured
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None