Ultrasound vs Palpation for Infant Lumbar Puncture
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02373774|
Recruitment Status : Completed
First Posted : February 27, 2015
Last Update Posted : September 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Spinal; Puncture, Complications||Device: Ultrasound||Not Applicable|
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).
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.
- 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
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sonographic Visualization vs Palpation Technique for Infant Lumbar Puncture|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
No Intervention: 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.
Experimental: 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.
Patients will receive an ultrasound prior to lumbar puncture procedure to help visualize and select spinal interspace.
Other Name: (Zonare Z1.pro and/or Sonosite Mturbo)
- Lumbar Puncture Success - composite score including lab results and reported attempts [ Time Frame: 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.
- Number of Attempts- per direct observation [ Time Frame: 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.
- Traumatic Lumbar Puncture- per lab results [ Time Frame: Outcome measured on the same day of the procedure ]Defined as cerebrospinal fluid with greater than 1000 red blood cells per highpowered field. (will look for first attempt and for overall)
- Initial Lumbar Interspace Selection- as measured during clip review [ Time Frame: Clip review for outcome will occur on average within one month of the procedure ]Defined as the lumbar interspace that the clinician performing the lumbar puncture initially inserts the lumbar puncture needle into, with the level determined by the post-procedural ultrasound by a blinded sonologist.
- Highest Lumbar Interspace Selectionas-measured during clip review [ Time Frame: Clip review for outcome occurs on average within one month of the procedure ]Defined as the lumbar interspace that the lumbar puncture needle is inserted that is the most caudal (when more than one is performed), with level determined by the post-procedural ultrasound by a blinded sonologist.
- Lumbar Puncture Success - as per lab results ( <1000 red blood cells per high powered field on any attempt) [ Time Frame: Outcome measured on the same day of the procedure ]Overall success will be defined as obtaining fluid with csf <1000 rbcs by any practitioner on any attempt
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373774
|United States, New York|
|NY, New York, United States, 10032|
|Principal Investigator:||David O Kessler, MD, MSc||Columbia University|
|Principal Investigator:||Gerald Behr, MD||Columbia University|
|Principal Investigator:||Peter S Dayan, MD, MSc||Columbia University|