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临床试验/NCT05302765
NCT05302765已完成不适用

Intravenous Fluid Administration's Effect on Pediatric Lumbar Puncture

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2022年11月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
182
试验地点
2
主要终点
Successful Lumbar Puncture

研究概览

简要总结

The purpose of this project is to determine if administration of normal saline intravenous fluids prior to a lumbar puncture improves first time success of lumbar puncture in infants less than 3 months of age. First time success of lumbar puncture defined as cerebrospinal fluid obtained on the first attempt with less than 1000 red blood cells per mm3 in the fluid specimen.

详细描述

Lumbar Puncture is a common procedure performed in the Pediatric Emergency Department. This procedure is often performed to assess the cerebrospinal fluid for infection. At Children's of Alabama, approximately 75% of patients undergoing this procedure are ages 3 months of age or younger. There is hypothesis that intravenous fluid administration prior to performing a lumbar puncture in this age group will increase the chances of obtaining non-bloody spinal fluid in less attempts.

A recent study by Rankin et al, infants 0 to 3 months with the diagnosis of pyloric stenosis in a pediatric emergency department were enrolled. This study measured the subarachnoid space in millimeters squared before and 1 hour after administration of normal saline intravenous fluid bolus with the use of ultrasound. The sample size was 40 patients with a mean age of 11.3 days. The study determined that fluid boluses were not associated with a significant increase in the sonographic measurement of the subarachnoid space. However, no lumbar punctures were actually performed in their study. Based on their results, they deduced that fluids may not increase lumbar puncture success rates. No studies have been published evaluating whether intravenous fluids affect the success rate of performed lumbar punctures.

A prospective randomized control trial will be performed with patients of the ages 0 to 3 months. Patients to be enrolled will be all patients 3 months or less in the Children's of Alabama Pediatric Emergency Department who will be undergoing a lumbar puncture procedure as part of their clinical work-up. The control arm will have the lumbar puncture performed in routine fashion without the administration of intravenous fluids prior to procedure. The experimental arm will undergo normal saline intravenous fluids (20 milliliters/kilogram) prior to lumbar puncture. The bolus is to be completed prior to performing the lumbar puncture in the experimental group.

Physicians and Nurse Practitioners caring for patients who are performing a lumbar puncture as part of their clinical work-up are responsible for identifying the patient as a candidate for the study. The providers identifies if patients in the age group are a candidate for enrollment based on inclusion and exclusion criteria.

If the patient is identified to be an acceptable candidate for the study, the provider caring for the patient notifies a physician in the Emergency Department who is qualified to obtain consent for the study. Consents are available in both English and Spanish. Once consent is obtained, providers obtain a sealed packet that contains a randomized assignment into one of the arms of the study. If the patient is assigned to the experimental arm, the provider orders a 20 mL/Kg normal saline intravenous fluid bolus and performs the lumbar puncture after the bolus has completed. If the patient is assigned to the control arm, the provider proceeds with the lumbar puncture without ordering or administering intravenous fluids.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
0 Months 至 3 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Ages 0 and 3 months
  • Patient at Children's of Alabama's Emergency Department
  • Undergoing a lumbar puncture as part of their clinical work-up

排除标准

  • Vertebral abnormalities
  • Severe scoliosis
  • Lumbar puncture to be performed by interventional radiology
  • Received intravenous fluids prior to study enrollment
  • Hypotension requiring fluid resuscitation
  • Shock requiring fluid resuscitation
  • Ultrasound assistance
  • Lumbar puncture performed or attempted at another hospital within 24 hours

结局指标

主要结局

Successful Lumbar Puncture

时间窗: 1 to 1.5 hours

Cerebrospinal fluid obtained on first attempt with less than 1000 red blood cells per mm3 in fluid.

次要结局

  • Time from intravenous fluid bolus completion to cerebrospinal fluid collection(0 minutes to 1.5 hours)
  • Level of trainings effect on successful lumbar punctures(1 to 1.5 hours)
  • Successfully Obtaining Cerebrospinal Fluid(1 to 1.5 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Austin Wheeler

Fellow

University of Alabama at Birmingham

研究点 (2)

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