Browse
Submit Data
Databases
API
Help

Dataset Information

15 Views

0 Connections

0 Citations

0 Reanalyses

0 Downloads

Omics score: 0

Remote-controlled cholangiography injection device: first clinical study in China.

ABSTRACT:

Background

X-ray cholangiography is of great value in the imaging of biliary tract diseases; however, occupational radiation exposure is unavoidable. Moreover, clinicians must manually inject the contrast dye, which may result in a relatively high incidence of adverse reactions due to unstable injection pressure. Thus, there is a need to develop a novel remote-controlled cholangiography injection device.

Methods

Patients with external biliary drainage requiring cholangiography were included. A remote-controlled injection device was developed with three major components: an injection pump, a pressure sensor, and a wireless remote-control panel. Image quality, adverse reactions, and radiation dose were evaluated.

Results

Different kinds of X-ray cholangiography were successfully and smoothly performed using this remote-controlled injection device in all patients. The incidence of adverse reactions in the device group was significantly lower than that in the manual group (4.17% vs. 13.9%, P = 0.001), and increasing the injection pressure increased the incidence of adverse reactions. In addition, the device helped operators avoid ionizing radiation completely.

Conclusions

With good control of injection pressure (within 10 kPa), the remote-controlled cholangiography injection device could replace the need for the doctor to inject contrast agent with good security and effectivity. It is expected to be submitted for clinical application.

SUBMITTER: Chen H

PROVIDER: S-EPMC8742431 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Json Xml

Similar Datasets

Fluorescent cholangiography: An up-to-date overview twelve years after the first clinical application.

Project description:Laparoscopic cholecystectomy (LC) is one of the most frequently performed gastrointestinal surgeries worldwide. Bile duct injury (BDI) represents the most serious complication of LC, with an incidence of 0.3%-0.7%, resulting in significant perioperative morbidity and mortality, impaired quality of life, and high rates of subsequent medico-legal litigation. In most cases, the primary cause of BDI is the misinterpretation of biliary anatomy, leading to unexpected biliary lesions. Near-infrared fluorescent cholangiography is widely spreading in clinical practice to delineate biliary anatomy during LC in elective and emergency settings. The primary aim of this article was to perform an up-to-date overview of the evolution of this method 12 years after the first clinical application in 2009 and to highlight all advantages and current limitations according to the available scientific evidence.

| S-EPMC8476339 | biostudies-literature

Performance of first pacemaker to use smart device app for remote monitoring.

Project description:BackgroundHigh adherence to remote monitoring (RM) in pacemaker (PM) patients improves outcomes; however, adherence remains suboptimal. Bluetooth low-energy (BLE) technology in newer-generation PMs enables communication directly with patient-owned smart devices using an app without a bedside console.ObjectiveTo evaluate the success rate of scheduled RM transmissions using the app compared to other RM methods.MethodsThe BlueSync Field Evaluation was a prospective, international cohort evaluation, measuring the success rate of scheduled RM transmissions using a BLE PM or cardiac resynchronization therapy PM coupled with the MyCareLink Heart app. App transmission success was compared to 3 historical "control" groups from the Medtronic de-identified CareLink database: (1) PM patients with manual communication using a wand with a bedside console (PM manual transmission), (2) PM patients with wireless automatic communication with the bedside console (PM wireless); (3) defibrillator patients with similar automatic communication (defibrillator wireless).ResultsAmong 245 patients enrolled (age 64.8±15.6 years, 58.4% men), 953 transmissions were scheduled through 12 months, of which 902 (94.6%) were successfully completed. In comparison, transmission success rates were 56.3% for PM manual transmission patients, 77.0% for PM wireless patients, and 87.1% for defibrillator wireless patients. Transmission success with the app was superior across matched cohorts based on age, sex, and device type (single vs dual vs triple chamber).ConclusionThe success rate of scheduled RM transmissions was higher among patients using the smart device app compared to patients using traditional RM using bedside consoles. This novel technology may improve patient engagement and adherence to RM.

| S-EPMC8505204 | biostudies-literature

Injection Cryolipolysis: First-in-human Study.

Project description:BackgroundInjection cryolipolysis using an ice slurry has been hypothesized to be a novel method of reducing fat. The present first-in-human pilot study aims to investigate the feasibility, safety, and tolerability of ice slurry injection into human subcutaneous fat.MethodsPreabdominoplasty subjects were recruited. Baseline measurements and serial follow-up visits following a single ice slurry injection procedure into tissue to be excised during abdominoplasty were performed. Melted ice slurry injection was used as control. Feasibility using standard injection techniques was assessed. Thermal imaging was used to determine cooling efficacy. Safety was assessed by adverse event monitoring. Tolerability was assessed by subject-reported pain score. Histology and ultrasound were monitored for structural changes associated with cryolipolysis.ResultsA single injection of ice slurry was feasible and sufficient to cool adipose below the target temperature (10C). There were no serious adverse events. The most common adverse events were bruising and erythema. The mean pain score for ice slurry-injected sites was 1.9/10 and 1.3/10 in control injection sites. Evidence of cryolipolysis was observed on ultrasound and tissue histology in ice slurry-injected sites.ConclusionsIce slurry injections are feasible, with an observed safety and tolerability profile comparable to topical cryolipolysis. The ice slurry can cool tissue to induce cryolipolysis, as observed by thermal imaging, ultrasound, and tissue histology, and is selective for ice-injected sites. No significant changes were observed in control sites. The ice slurry may be a promising candidate to enable more precise, effective, and customizable aesthetic fat reduction that warrants further investigation.

| S-EPMC8462637 | biostudies-literature

Effect of the Cardio First Angel™ device on CPR indices: a randomized controlled clinical trial.

Project description:BackgroundA number of cardiopulmonary resuscitation (CPR) adjunct devices have been developed to improve the consistency and quality of manual chest compressions. We investigated whether a CPR feedback device would improve CPR quality and consistency, as well as patient survival.MethodsWe conducted a randomized controlled study of patients undergoing CPR for cardiac arrest in the mixed medical-surgical intensive care units of four academic teaching hospitals. Patients were randomized to receive either standard manual CPR or CPR using the Cardio First Angel™ CPR feedback device. Recorded variables included guideline adherence, CPR quality, return of spontaneous circulation (ROSC) rates, and CPR-associated morbidity.ResultsA total of 229 subjects were randomized; 149 were excluded; and 80 were included. Patient demographics were similar. Adherence to published CPR guidelines and CPR quality was significantly improved in the intervention group (p < 0.0001), as were ROSC rates (72 % vs. 35 %; p = 0.001). A significant decrease was observed in rib fractures (57 % vs. 85 %; p = 0.02), but not sternum fractures (5 % vs. 17 %; p = 0.15).ConclusionsUse of the Cardio First Angel™ CPR feedback device improved adherence to published CPR guidelines and CPR quality, and it was associated with increased rates of ROSC. A decrease in rib but not sternum fractures was observed with device use. Further independent prospective validation is warranted to determine if these results are reproducible in other acute care settings.Trial registrationClinicalTrials.gov identifier: NCT02394977 . Registered on 5 Mar 2015.

| S-EPMC4869179 | biostudies-literature

Laparoscopic cholecystectomy for cholecystitis using direct gallbladder indocyanine green injection fluorescence cholangiography: A case report.

Project description:<introduction>Laparoscopic cholecystectomy is the treatment of choice for almost all biliary diseases. We present a novel technique using near-infrared fluorescence imaging for laparoscopic cholecystectomy.<case presentation >A 78-year-old woman diagnosed with acute cholecystitis (Grade II) was scheduled for emergency laparoscopy according to Tokyo Guidelines 2018. We performed a direct percutaneous drainage of the gallbladder to grasp the gallbladder itself. Subsequently, indocyanine green was administered into the gallbladder through the same tube, and the cystic and common bile ducts could be easily detected. The postoperative course was good, and the patient was discharged in remission nine days after the surgery.<discussion>Real-time fluorescence cholangiography with indocyanine green is reliable for biliary anatomy visualization before the dissection of the Calot's triangle. Our method of indocyanine green injection into the same drainage catheter does not require pre-preparation and can be simultaneously performed with drainage intraoperatively. This surgical technique is simple, straightforward, and effective and can be useful in intraoperative decision-making, especially during laparoscopic cholecystectomy.

| S-EPMC7415627 | biostudies-literature

Efficacy of vibrotactile device DentalVibe in reducing injection pain and anxiety during local anaesthesia in paediatric dental patients: a study protocol for a randomised controlled clinical trial.

Project description:INTRODUCTION:A current non-pharmacological mean for attaining painless local anaesthesia (LA) is presented by vibrotactile devices. Their concept is to reduce injection pain due to distraction by applying physical stimuli which interfere with pain signals. The aim of this study is to determine the efficacy of the DentalVibe (DV) device in reducing pain and anxiety associated with LA in paediatric patients. METHODS AND ANALYSIS:The proposed study is a randomised controlled clinical trial with split-mouth design. Included are positive patients aged 8-12 years, requiring buccal infiltration for extraction of two bilateral primary maxillary molars. After dental fear measurement, eligible patients undergo two single-visit treatments with DV device allocated to either first or second LA via computer-generated randomisation sequence. Outcome measures will be self-reported pain felt during LA on Visual Analogue Scale; self-reported anxiety on Facial Image Scale; pain-related behaviour according to Faces, Legs, Activity, Cry, Consolability Scale; heart rate; patient preference to LA technique.Data will be analysed with intention-to-treat concept by Student's t-test for paired samples, Wilcoxon signed-rank test, p<0.05. Pretest on 20 subjects resulted in n=41 patients sample size. ETHICS AND DISSEMINATION:This study protocol has been approved by the Committee for Scientific Research Ethics, Medical University - Plovdiv, Bulgaria (Reference number P-8604, Protocol of approval No. 6/23.11.2017) and registered on a publicly accessible database. This research received institutional funding from the Medical University - Plovdiv, Bulgaria, under project SPD-03/2017. Findings will be reported in scientific publications and at research conferences, and in project summary papers for participants. TRIAL REGISTRATION NUMBER:NCT03445182; Pre-results.

| S-EPMC6609117 | biostudies-literature

The first remote monitoring experience in South Korea: results of a remote-care study.

Project description: Not available

| S-EPMC10254071 | biostudies-literature

Biliary Anatomy Visualization and Surgeon Satisfaction Using Standard Cholangiography versus Indocyanine Green Fluorescent Cholangiography during Elective Laparoscopic Cholecystectomy: A Randomized Controlled Trial.

Project description:Background: Intraoperative biliary anatomy recognition is crucial for safety during laparoscopic cholecystectomy, since iatrogenic bile duct injuries represent a fatal complication, occurring in up to 0.9% of patients. Indocyanine green fluorescence cholangiography (ICG-FC) is a safe and cost-effective procedure for achieving a critical view of safety and recognizing early biliary injuries. The aim of this study is to compare the perioperative outcomes, usefulness and safety of standard intraoperative cholangiography (IOC) with ICG-FC with intravenous ICG. Methods: Between 1 June 2021 and 31 December 2022, 160 patients undergoing elective LC were randomized into two equal groups: Group A (standard IOC) and group B (ICG-FC with intravenous ICG). Results: No significant difference was found between the two groups regarding demographics, surgery indication or surgery duration. No significant difference was found regarding the visualization of critical biliary structures. However, the surgeon satisfaction and cholangiography duration presented significant differences in favor of ICG-FC. Regarding the inflammatory response, a significant difference between the two groups was found only in postoperative WBC levels. Hepatic and renal function test results were not significantly different between the two groups on the first postoperative day, except for direct bilirubin. No statistically significant difference was noted regarding 30-day postoperative complications, while none of the complications noted included bile duct injury events. Conclusions: ICG-FC presents equivalent results to IOC regarding extrahepatic biliary visualization and postoperative complications. However, more studies need to be performed in order to standardize the optimal dose, timing and mode of administration.

| S-EPMC10856121 | biostudies-literature

The first survey on patient needs for remote monitoring of cardiac implantable electronic device in South Korea.

Project description:Background/aimsStudies showed that remote device monitoring reduced unnecessary outpatient visits and increased patient satisfaction. As there was no local research on remote monitoring (RM) in Korea, there was a lack of evidence for policy or insurance standards due to the lack of domestic data despite high demand by domestic arrhythmia experts. To establish the basis for patient satisfaction, economic efficiency, and safety of wireless monitoring, a survey-based study was planned.MethodsThis was a single-university hospital survey. The satisfaction index was evaluated using a questionnaire to investigate patient satisfaction in outpatient clinics, economic efficiency (measured as home-to-clinic time, waiting time, and actual clinic time), and demand for RM in patients with implantable cardiac devices. The questionnaire was adopted and modified from the Survey on Telehealth Patient Experience by Bas-Villalobos, 2006 (modified Korean version 2.0 by You Mi Hwang, 2020).ResultsSurveys were answered by 171 patients. The mean age of these patients was 71.2 ± 12.4 years. Based on the survey, home to clinic time was usually less than one h, mean waiting time in the hospital until clinic time ranged 42.6 ± 24.5 minutes, and mean clinic time ranged 3.1 ± 1.7 minutes. Based on the survey, patients favored RM over hospital visits with cardiac implantable electronic device follow-up mainly because of long travel times from home to clinic.ConclusionBased on the survey results, there is a clear need for RM in patients who have cardiac implantable electronic devices.

| S-EPMC9276406 | biostudies-literature

First remote-controlled robotic-enhanced balloon pulmonary angioplasty to chronic thromboembolic pulmonary hypertension.

Project description: Not available

| S-EPMC8603244 | biostudies-literature