Dataset Information

First-in-human evaluation of a hand-held automated venipuncture device for rapid venous blood draws.

ABSTRACT: Obtaining venous access for blood sampling or intravenous (IV) fluid delivery is an essential first step in patient care. However, success rates rely heavily on clinician experience and patient physiology. Difficulties in obtaining venous access result in missed sticks and injury to patients, and typically require alternative access pathways and additional personnel that lengthen procedure times, thereby creating unnecessary costs to healthcare facilities. Here, we present the first-in-human assessment of an automated robotic venipuncture device designed to safely perform blood draws on peripheral forearm veins. The device combines ultrasound imaging and miniaturized robotics to identify suitable vessels for cannulation and robotically guide an attached needle toward the lumen center. The device demonstrated results comparable to or exceeding that of clinical standards, with a success rate of 87% on all participants (n = 31), a 97% success rate on nondifficult venous access participants (n = 25), and an average procedure time of 93 ± 30 s (n = 31). In the future, this device can be extended to other areas of vascular access such as IV catheterization, central venous access, dialysis, and arterial line placement.

SUBMITTER: Leipheimer JM

PROVIDER: S-EPMC7156113 | biostudies-literature | 2019 Sep-Dec

REPOSITORIES: biostudies-literature

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First-in-human evaluation of a hand-held automated venipuncture device for rapid venous blood draws.

Leipheimer Josh M JM Balter Max L ML Chen Alvin I AI Pantin Enrique J EJ Davidovich Alexander E AE Labazzo Kristen S KS Yarmush Martin L ML

Technology 20190901 3-4

Obtaining venous access for blood sampling or intravenous (IV) fluid delivery is an essential first step in patient care. However, success rates rely heavily on clinician experience and patient physiology. Difficulties in obtaining venous access result in missed sticks and injury to patients, and typically require alternative access pathways and additional personnel that lengthen procedure times, thereby creating unnecessary costs to healthcare facilities. Here, we present the first-in-human ass ...[more]

PMID: 32292800

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Project description:Background:The diagnostic performance of an automated breast volume scanner (ABVS) compared with that of a hand-held ultrasound (HHUS) for breast cancer remains unclear. We performed a meta-analysis to compare the diagnostic performances of the ABVS and HHUS for breast cancer. Methods:We searched PubMed, EMBASE, Cochrane, and SinoMed databases to identify eligible studies up until November 14, 2018. Studies comparing ABVS and HHUS for differentiating benign and malignant breast tumors were included. A meta-analysis was performed to generate pooled diagnostic accuracy parameters [sensitivity, specificity, diagnostic odds ratio (DOR), area under the curve (AUC), and the Q* index] and detection rates for ABVS and HHUS. Results:Nine studies involving 1,376 patients and 1,527 lesions were included in the meta-analysis for diagnostic accuracy. The pooled sensitivity was 0.93 [95% confidence interval (CI), 0.91-0.95] for ABVS and 0.90 (95% CI, 0.88-0.92) for HHUS, and the pooled specificity was 0.86 (95% CI, 0.83-0.88) for ABVS and 0.82 (95% CI, 0.79-0.84) for HHUS. The pooled DOR was 88.66 (95% CI, 51.44-152.78) for ABVS and 41.06 for HHUS (95% CI, 26.58-63.42). The AUC of the summary receiver operating characteristic (SROC) was 0.9496 for ABVS and 0.9143 for HHUS, and the Q* index was 0.8899 for ABVS and 0.8469 for HHUS. Meta-regression showed no significant difference between the diagnostic accuracy of ABVS and HHUS (P=0.0771). No publication bias was found. Thirteen published studies involving 1,047 pathologically confirmed malignant lesions were included to generate a pooled detection rate. The pooled detection rate was 1.00 (95% CI, 1.00-1.00) for both ABVS and HHUS, for which a publication bias was found. Conclusions:ABVS can be used as an appropriate screening tool for breast cancer as well as HHUS in diagnostic accuracy and detection rate. Considering other advantages of ABVS including non-radioactivity, sensitivity to dense breast, three-dimensional reconstruction, time-saving and repeatability, it might be a promising screening tool for young or dense-breast women in the future.

Project description:An in-line smartphone connected to a screen-printed selective electrode hand-held device was used to determine the concentration of distigmine bromide (DB) in its pure and dosage forms as well as its degradation kinetics by continuously measuring the change in the produced emf over time. The main objective, supported by the data presented, is to produce a highly reliable smartphone integrated selective sensor as a portable analyzer with potential high cloud connectivity combining a wide linear dynamic range, the fastest response time with the lowest limits of detection and quantitation while best integrating green analytical chemistry principles. The choice of ionophore used in this approach was guided by computation and the data obtained was compared with traditional analytical techniques. DB, for which there are no previously reported stability-indicating methods and for which four novel such methods are proposed here, was selected as a model drug for this work. At-line UV-spectrophotometry DB assay was obtained by measuring the difference between the spectra of the degradation product and the same concentration of intact drug. The degradation kinetics were studied by this method through tracking the decrease of DB absorbance and/or the increase of a generated degradation product signal over time. Off-line separation based HPLC and TLC stability-indicating methods for DB were also presented. All methods employed in this work were validated for accuracy, precision, specificity, repeatability, linearity, range, detection and quantification limits according to the ICH guidelines and were applied to the analysis of laboratory prepared mixtures as well as commercial products. While all methods proposed were shown to be highly reliable, the smartphone integrated selective sensor is highlighted as a portable analyzer with potential high cloud connectivity and was shown to combine a wide linear dynamic range, the fastest response time with the lowest limits of detection and quantitation while best integrating green analytical chemistry principles.

Dataset Information

First-in-human evaluation of a hand-held automated venipuncture device for rapid venous blood draws.

Publications

First-in-human evaluation of a hand-held automated venipuncture device for rapid venous blood draws.

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