Trial Outcomes & Findings for Ultrasound vs Palpation for Infant Lumbar Puncture (NCT NCT02373774)

Last Updated: 2023-10-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

81 participants

Primary outcome timeframe

Outcome measured on the same day of the procedure

Results posted on

2023-10-24

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	40	41
Overall Study COMPLETED	40	38
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Participant sex was not collected

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Anatomic Palpation Technique n=40 Participants 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.	Pre-Procedural Ultrasound n=41 Participants 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.	Total n=81 Participants Total of all reporting groups
Age, Categorical <=18 years	40 Participants n=40 Participants	41 Participants n=41 Participants	81 Participants n=81 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=40 Participants	0 Participants n=41 Participants	0 Participants n=81 Participants
Age, Categorical >=65 years	0 Participants n=40 Participants	0 Participants n=41 Participants	0 Participants n=81 Participants
Age, Continuous	25.4 days STANDARD_DEVIATION 19.4 • n=40 Participants	29.9 days STANDARD_DEVIATION 19.3 • n=41 Participants	27.6 days STANDARD_DEVIATION NA • n=81 Participants
Sex: Female, Male Female	—	—	0 Participants Participant sex was not collected
Sex: Female, Male Male	—	—	0 Participants Participant sex was not collected
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	40 participants n=40 Participants	41 participants n=41 Participants	81 participants n=81 Participants

PRIMARY outcome

Timeframe: Outcome measured on the same day of the procedure

Outcome measures

Outcome measures
Measure	Standard Anatomic Palpation Technique n=40 Participants 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.	Pre-Procedural Ultrasound n=38 Participants 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.
Lumbar Puncture Success - Composite Score Including Lab Results and Reported Attempts	18 Participants	19 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Standard Anatomic Palpation Technique n=40 Participants 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.	Pre-Procedural Ultrasound n=38 Participants 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.
Number of Attempts- Per Direct Observation	2 number of attempts Interval 1.0 to 3.0	2 number of attempts Interval 1.0 to 2.0

Adverse Events

Standard Anatomic Palpation Technique

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pre-Procedural Ultrasound

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Raquel Schrager

Columbia University Medical Center

Phone: (212) 305-4687

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place