A previous champagne tap reduces the probability of traumatic lumbar puncture in the following procedure.

A cerebrospinal fluid (CSF) sample containing no red blood cells (RBC), colloquially known as a champagne tap, is an ideal outcome of a lumbar puncture (LP). In this pseudoprospective study of 2573 patients aged from 0 days to 95 years, we examined in four different age categories (neonates and infants, children and adolescents, adults, and older adults) whether a champagne tap in the patient's first LP procedure and a shorter time than 1 week between the two successive procedures are independently associated with fewer blood-contaminated CSF samples (traumatic LP) in the following procedure. One out of five CSF samples from the patient's first LP procedures were RBC-free on average, varying from about 9% in neonates and infants to about 36% in children and adolescents. The mean incidence of champagne taps was 19.5%. According to binary logistic regression, a champagne tap in the previous LP procedure significantly determined whether the following procedure was not blood-contaminated. The odds of traumatic LP were halved or even reduced tenfold after a champagne tap. Less than a week between the two successive procedures, in turn, multiplied the odds of traumatic LP in the latter even more than tenfold. A champagne tap was not significantly associated with traumatic LP in the following procedure among pediatric patients. If the patient's condition or therapy plan permits and the blood contamination can compromise the reliability of the CSF-based analysis and consequent diagnosis, postponing the LP procedure by several days is advisable to improve the odds of receiving a high-quality CSF sample.

Success and complications in lumbar punctures of pediatric patients with leukemia: a study protocol for a randomized clinical crossover trial of a bioimpedance needle system versus conventional procedure.

BACKGROUND: Acute lymphoblastic leukemia (ALL) is the most common malignancy diagnosed in children. At present, the long-term survival from pediatric ALL is well over 90%. However, the probability of event-free survival is reduced if the lumbar puncture (LP) procedures at the beginning of the patient's intrathecal therapy cause blood leakage into the spinal canal and blast cells contaminate the cerebrospinal fluid. According to the literature, such traumatic LP procedures concern one out of five pediatric patients with ALL. Recently, a novel medical device measuring the tissue bioimpedance at the tip of a spinal needle was found feasible in pediatric patients with ALL. The LP procedure was successful at the first attempt in 80% of procedures, and the incidence of traumatic LPs was then 11%. The purpose of the present study is to compare the bioimpedance spinal needle system with the standard clinical practice resting on a conventional spinal needle and investigate its efficacy in clinical practice. METHODS: The study is a multicenter, randomized, two-arm crossover noninferiority trial of pediatric hemato-oncology patients that will be conducted within the usual clinical workflow. Patients' LP procedures will be performed alternately either with the IQ-Tip system (study arm A) or a conventional Quincke-type 22G spinal needle (study arm B). For each enrolled patient, the order of procedures is randomly assigned either as ABAB or BABA. The total number of LP procedures will be at least 300, and the number of procedures per patient between two and four. After each study LP procedure, the performance will be recorded immediately, and 1-week diary-based and 4-week record-based follow-ups on symptoms, complications, and adverse events will be conducted thereafter. The main outcomes are the incidence of traumatic LP, first puncture success rate, and incidence of post-dural puncture headache. DISCUSSION: The present study will provide sound scientific evidence on the clinical benefit, performance, and safety of the novel bioimpedance spinal needle compared with the standard clinical practice of using conventional spinal needles in the LP procedures of pediatric patients with leukemia. TRIAL REGISTRATION: ISRCTN ISRCTN16161453. Registered on 8 July 2022.

Incidence of traumatic lumbar punctures in adults: the impact of a patient's first procedure.

INTRODUCTION: Lumbar puncture (LP) is a widely used diagnostic method in patients of all ages. Blood-contaminated cerebrospinal fluid samples are frequent and may compromise diagnostic accuracy. OBJECTIVES: We determined age-specific incidences of traumatic LPs (TLPs) in adults and examined factors that accounted for the incidence of TLPs. METHODS: Erythrocyte count data from 15,812 LP procedures (2,404 were performed twice) were collected from hospital records of patients aged from 18 to 104 years. The incidence of TLPs in a patient's second LP procedure was evaluated with logistic regression analysis using the first LP, the time between the procedures and age as predictors. RESULTS: The incidence of TLP in the second procedure was at least double that in the first procedure. If the first procedure was traumatic, the odds ratio of a TLP in the second procedure was 7-40-fold. One day between the successive procedures was associated with an over 10-fold odds ratio increase of TLP, and a week was still 4-8-fold odds ratio increase. Age was also associated with the incidence of TLP. CONCLUSIONS: Two factors (a week or less between a patient's two LP procedures or a traumatic first LP) multiply the odds of the second procedure being traumatic and contribute to whether a patient's following LP procedure is successful.

Incidence of Traumatic Lumbar Punctures in Neonates and Infants.

OBJECTIVE: The objective of this study is to examine factors accounting for the incidence of traumatic lumbar puncture (TLP) in infants younger than 1 year old. STUDY DESIGN: Retrospective analysis of cerebrospinal fluid (CSF) data from 1,240 neonatal (≤28 days) and 399 infant lumbar puncture (LP) procedures was conducted. Data from two successive LP procedures were obtained from 108 patients. Logistic regression analysis was used to assess factors accounting for the incidence of TLP in the second LP procedure. The following categorical variables were entered into the model: whether the first procedure was traumatic according to criteria of ≥500 and ≥10,000 erythrocytes/µL, whether the LP procedures were performed within a week, and whether the patient was neonatal at the first procedure. RESULTS: The incidences of TLP were 42.9% in neonates and 22.5% in infants for the criterion of ≥500 erythrocytes/µL, and 16.6 and 10.3% for the criterion of ≥10,000 erythrocytes/µL. Compared with a nontraumatic first LP procedure, if the first procedure was traumatic according to the criterion of ≥10,000 erythrocytes/µL, the odds ratio (OR) of TLP in the second procedure was 5.86 (p = 0.006). Compared with a longer time, if the successive procedures were performed within a week, the OR of TLP was 9.06 (p < 0.0001) according to the criteria of ≥500 erythrocytes/µL and 3.34 (p = 0.045) according to the criteria of ≥10,000 erythrocytes/µL. If the patient was neonatal at the first procedure, the OR of TLP at the second puncture was 0.32 (p = 0.031) according to the criterion of ≥500 erythrocytes/µL. CONCLUSIONS: The incidence of TLP in neonates is twice as high as that in infants. Successive LP procedures performed within a week and a highly blood-contaminated CSF sample in the first procedure each multiplied the odds of TLP in the second procedure, whereas being a neonate at the time of the first procedure reduced the odds of TLP. KEY POINTS: · Traumatic LPs increase diagnostic uncertainty.. · Traumatic LPs are twice as common in neonates as in infants.. · Two LPs performed within a week multiplied the odds of traumatic LP.. · Erythrocyte-based criteria for traumatic LP affect the incidence of TLP..

Traumatic lumbar punctures in diagnostic and intrathecal treatment punctures of pediatric hemato-oncology patients.

Successful first diagnostic lumbar puncture (LP) is crucial because intrathecal chemotherapy has not yet protected the central nervous system against cancer cells. If blood contaminates the cerebrospinal fluid (CSF) with blasts, they may enter the central neural system and compromise the patient's health. We retrospectively determined the incidence of traumatic lumbar punctures (TLP) in 2,507 LPs of 250 pediatric hemato-oncology patients aged from one to 18 years, including both diagnostic and intrathecal treatment procedures, and 2,617 LPs of 1,525 other age-matched pediatric patients. We used ≥10 erythrocytes/µL in the CSF sample as the criterion of TLP. TLPs were less frequent in hemato-oncology patients than in other patients (31.6% vs. 48.5%, p < 0.0001). The incidence of TLP was significantly lower in the first diagnostic LP than in subsequent intrathecal treatment LPs (20.5% vs. 31.6%, p = 0.0046). According to logistic regression analysis, the odds of TLP was 1.6-fold if the LP procedure was not performed in the hemato-oncology department. The odds of the patient's next LP being traumatic were threefold if the previous first LP was traumatic. A week or less time between the first and next LP tripled the odds of TLP as well. The patient's age category was not significantly associated with the incidence of TLP. Given the risks of TLP, hemato-oncology patients' first diagnostic LP should include administration of chemotherapy, as generally recommended, and be performed under general anesthesia or deep sedation by an experienced physician to optimize not only the success of the first LP procedure but also following procedures.

Bioimpedance spinal needle provides high success and low complication rate in lumbar punctures of pediatric patients with acute lymphoblastic leukemia.

In this prospective single-arm study of 50 pediatric patients with acute lymphoblastic leukemia (ALL), we evaluated the clinical performance of a novel bioimpedance spinal needle system in 152 intrathecal treatment lumbar punctures (LP) of these patients. The system detects in real-time when the needle tip reaches the cerebrospinal fluid (CSF) in the spinal canal. The success was defined as getting a CSF sample and/or administering the intrathecal treatment with one needle insertion. Incidence of traumatic LP (TLP) was defined as ≥ 10 erythrocytes/µL of CSF. Post-procedural complications were monitored with a one-week diary and one-month register follow-up. The success of the first attempt was 79.5%, with the CSF detection sensitivity of 86.1%. The incidence of TLP was 17.3%. A successful first attempt was associated with a significantly lower incidence of TLP (10% vs 40%, p = 0.0015). During the week after the procedure, the incidence of post-dural puncture headache was 6%. During the follow-up, no major complications were observed. In conclusion, the novel bioimpedance spinal needle system achieved a high success rate and low incidence of TLP and other complications in pediatric patients with ALL in a real-world clinical setting, indicating clinical utility for this system in pediatric hemato-oncology.

Humanin vivoliver and tumor bioimpedance measured with biopsy needle.

Objective.Liver biopsy is an essential procedure in cancer diagnostics but targeting the biopsy to the actual tumor tissue is challenging. Aim of this study was to evaluate the clinical feasibility of a novel bioimpedance biopsy needle system in liver biopsy and simultaneously to gatherin vivobioimpedance data from human liver and tumor tissues.Approach.We measured human liver and tumor impedance datain vivofrom 26 patients who underwent diagnostic ultrasound-guided liver biopsy. Our novel 18 G core biopsy needle tip forms a bipolar electrode that was used to measure bioimpedance during the biopsy in real-time with frequencies from 1 kHz to 349 kHz. The needle tip location was determined by ultrasound. Also, the sampled tissue type was determined histologically.Main results.The bioimpedance values showed substantial variation between individual cases, and liver and tumor data overlapped each other. However, Mann-Whitney U test showed that the median bioimpedance values of liver and tumor tissue are significantly (p < 0.05) different concerning the impedance magnitude at frequencies below 25 kHz and the phase angle at frequencies below 3 kHz and above 30 kHz.Significance.This study uniquely employed a real-time bioimpedance biopsy needle in clinical liver biopsies and reported the measured humanin vivoliver and tumor impedance data. Impedance is always device-dependent and therefore not directly comparable to measurements with other devices. Although the variation in tumor types prevented coherent tumor identification, our study provides preliminary evidence that tumor tissue differs from liver tissuein vivo,and this association is frequency-dependent.

Real-time detection of cerebrospinal fluid with bioimpedance needle in paediatric lumbar puncture.

BACKGROUND: Lumbar puncture is a common clinical procedure that can occasionally be difficult. Various needle guidance methods can facilitate performing this procedure, but at the expense of special expertise, equipment and facility. In the present study, we evaluated the clinical feasibility of a novel bioimpedance needle system regarding its ability to detect cerebrospinal fluid (CSF) in paediatric lumbar punctures. METHODS: We performed 40 lumbar puncture procedures using the bioimpedance needle system in 37 paediatric patients, aged from 0 days to 17 months, as a part of their prescribed examinations in two university hospitals. The bioimpedance needle is similar to a conventional 22G cutting-edge spinal needle with a stylet, except the needle and stylet are configured as a bipolar electrode with high spatial resolution. The system measures in real-time when the needle tip reaches the subarachnoid space containing CSF. The procedure was considered successful when the erythrocyte count was determined from the obtained CSF sample. RESULTS: Subarachnoid space was verifiably reached in 28 out of 40 procedures (70%). Bioimpedance needle system detected CSF in 23 out of these 28 successful procedures (82%) while failed in 3 out of 28 procedures (11%). No adverse events were reported. CONCLUSION: Bioimpedance spinal needle system was found clinically feasible in paediatric lumbar punctures, and it may offer an objective and simple means to detect the time point when the needle tip is in contact with the cerebrospinal fluid.

Real-Time Bioimpedance-Based Biopsy Needle Can Identify Tissue Type with High Spatial Accuracy.

Histological analysis is meaningful in diagnosis only if the targeted tissue is obtained in the biopsy. Often, physicians have to take a tissue sample without accurate information about the location of the instrument tip. A novel biopsy needle with bioimpedance-based tissue identification has been developed to provide data for the automatic classification of the tissue type at the tip of the needle. The aim of this study was to examine the resolution of this identification method and to assess how tissue heterogeneities affect the measurement and tissue classification. Finite element method simulations of bioimpedance measurements were performed using a 3D model. In vivo data of a porcine model were gathered with a moving needle from fat, muscle, blood, liver, and spleen, and a tissue classifier was created and tested based on the gathered data. Simulations showed that very small targets were detectable, and targets of 2 × 2 × 2 mm3 and larger were correctly measurable. Based on the in vivo data, the performance of the tissue classifier was high. The total accuracy of classifying different tissues was approximately 94%. Our results indicate that local bioimpedance-based tissue classification is feasible in vivo, and thus the method provides high potential to improve clinical biopsy procedures.

Synovial fluid detection in intra-articular injections using a bioimpedance probe (BIP) needle-a clinical study.

Intra-articular glucocorticoid injections are the recommended treatment for active arthritis, but accurate positioning of the needle may be challenging. Inexperienced physicians might decide not to inject because an unsuccessful injection impairs clinical outcome and may lead to complications; however, choosing not to inject may impair or delay the best possible treatment. Here, we address this problem by introducing a novel Bioimpedance Probe (BIP) Needle-guidance method that was tested in a clinical study. The BIP Needle was utilized for detection of synovial fluid. It measures real-time bioimpedance spectra and identifies when the needle tip is in contact with the synovial fluid. Injections into 80 joints with active arthritis were performed by an experienced rheumatologist using the BIP Needle. The location of the BIP Needle was ensured by aspiration of synovial fluid, absence of resistance during injection, and/or using real-time ultrasound imaging. Sensitivity and specificity of the device for synovial fluid detection were 86 % (CI 75-93 %) and 85 % (CI 74-92 %), respectively. The BIP Needles showed high spatial resolution and differentiated the synovial fluid from the surrounding tissues. However, lack of synovial fluid, anatomic variability, and intra-articular structures challenged the technology. The BIP Needles provided adequate results in intra-articular injections. Performance of the device was good even in small joints, which may be the most difficult for inexperienced physicians. Further performance improvement can be expected when more data is collected for mathematical models. Overall, this novel method showed potential to be used in real-time needle guidance.

Detection of spine structures with Bioimpedance Probe (BIP) Needle in clinical lumbar punctures.

Lumbar puncture is a relatively safe procedure, but some serious, even fatal, complications can occur. Needle guidance can increase puncture accuracy, decrease the number of attempts, and make the procedure easier. We tested the feasibility of a bioimpedance-based tissue-sensing technology for needle guidance in clinical use. The Bioimpedance Probe (BIP) Needle has a removable BIP stylet enabling measurement of bioimpedance spectra during the procedure. The BIP Needle is connected to a measurement device that uses tissue-classification software, and the device provides audiovisual feedback when it detects cerebrospinal fluid (CSF). We performed spinal anesthesia with the BIP Needle in 45 patients. The device performance and needle tip location were verified by an experienced anesthesiologist confirming CSF leakage. The device detected CSF in all cases (sensitivity of 100 %). Six cases with false detections lowered the specificity to 81 %, but in practice, most of these were easy to differentiate from true detections because their duration was short and they occurred during backward movement of the needle. The epidural spectrum differentiated as fatty tissue from surrounding tissues, but the ligamentum flavum was not clearly detectable in the data. The BIP Needle is a reliable tool for detecting CSF in lumbar puncture. It can make the puncture procedure smoother, as repeated CSF flow tests are avoided. The correct needle tip location is immediately detected, thus unnecessary needle movements close to spinal nerves are prevented. Physicians could benefit from the information provided by the BIP Needle, especially in patients with obesity or anatomic alterations.