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Results | Thirty patients were randomized into two groups: Surgery Group (SG, | PMC10017559 | ||
Conclusion | gastro-cutaneous fistula, post-LSG gastric leak | Endoscopic intervention may offer a successful modality in managing post-LSG gastric leak and gastro-cutaneous fistula that do not respond to conservative measures in stable patients. | PMC10017559 | |
Keywords | MORBID OBESITY | Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB).Laparoscopic sleeve gastrectomy (LSG) is one of the most performed surgical procedures for treatment of morbid obesity [ | PMC10017559 | |
Patients and methods | PMC10017559 | |||
Patients | gastric leak, fistula | MAY, SECONDARY, RECURRENCE | We included all bariatric patients who developed gastric leak or fistula after LSG either performed at the Department of Surgery, Zagazig University Faculty of Medicine or referred to our department between December 2019 and March 2021. While all included patients were of the American Society of Anesthesiologists (ASA)... | PMC10017559 |
Diagnosis | gastric leak, fistula, gastro-cutaneous fistula | FREE FLUID | After full history taking and complete physical examination, post-LSG gastric leak was clinically suspected and then confirmed by laboratory investigations (complete blood picture, liver and kidney functions, coagulation profile), radiological imaging (chest X-ray, computed tomography (CT) with oral and I.V contrast) a... | PMC10017559 |
Intervention | Over-The-Scope, OverStitch, fistula | Patients, randomized to the endoscopy group, underwent endoscopic stenting (fully covered self-expanded metallic stent, FCSEMS) in case of gastric leak, endoscopic Over-The-Scope Clipping (OTSC, Ovesco Endoscopy AG, Tubingen, Germany) in case of gastric-cutaneous fistula, endoscopic suturing (OverStitch [ | PMC10017559 | |
Follow up after endoscopy and discharge from the hospital | DILATION | All patients were clinically examined, and laboratory checked during the hospital stay. Any suspected gastric leak post repair mandated CT scan with oral and I.V contrast and upper GI endoscopy. After discharge, patients who had undergone balloon dilation as a part of their repair procedure, were endoscoped every 4 wee... | PMC10017559 | |
Statistical analysis | Analysis of data was performed using SPSS (Statistical Package of Social Services) version 22. Quantitative variables were described as mean (± SD, standard deviation) and median (range) according to Shapiro test of normality. Qualitative variables were described as number and percentage. Chi-square test was used to co... | PMC10017559 | ||
Results | post-LSG leak, fistula, post-LSG gastric leak | Of 67 (12 and 55 post-LSG leak or fistula patients with primary surgery performed in our department and other centers, respectively) patients who presented with post-LSG leak or fistula, 30 patients (12/30 and 18/30 with primary LSG performed in our department and other centers, respectively) met the inclusion criteria... | PMC10017559 | |
Discussion | fits, fistula, gastro-cutaneous fistula, leaks, adhesions | RECURRENCE, COMPLICATION, STRICTURE, ANASTOMOTIC LEAK, DILATION, ADHESIONS | In general, the most frightful complication after bariatric surgery is the anastomotic leak with an incidence of 0.8–6% [In our department, we perform about 500 LSG/year, and the incidence of post-LSG leaks or fistula is about 2.5%. Surgical management of gastro-cutaneous fistula after laparoscopic sleeve gastrectomy h... | PMC10017559 |
Author contributions | The manuscript has been read and approved by all the authors; the requirements for authorship have been met; each author believes that the manuscript represents honest work. SN, AF and AS were directly involved in the entire procedure and designed the clinical case. BM screened the literature MA and TA were responsible... | PMC10017559 | ||
Funding | Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). The authors Said Negm, Ahmed Farag, Ahmed Shafiq, Bassam Mousa, Taha Abdelkader, Mohamed Abozied, Adel Attia, Ehab Abdella no funding to declare. | PMC10017559 | ||
Data availability | MINOR | All data generated during this study are included in this published article and its supplementary information files. Further minor datasets are available from the corresponding author on reasonable request. | PMC10017559 | |
Declarations | PMC10017559 | |||
Disclosures | The authors Said Negm, Ahmed Farag, Ahmed Shafiq, Bassam Mousa, Taha Abdelkader, Mohamed Abozied, Adel Attia, Ehab Abdella declare that they have no competing interests. | PMC10017559 | ||
Ethical approval | MAY | The study was prospectively approved by Zagazig University Faculty of Medicine Institutional Review Board (Approval Number: 11130/2.12.2019), and was retrospectively submitted in clinicaltrials.gov in May 2021 (NCT04879667). The study was performed in accordance with the code of ethics of the World Medical Association ... | PMC10017559 | |
Informed consent | Written informed consent was obtained from all participants after explaining to them all the study procedures with its benefits and hazards. | PMC10017559 | ||
Consent for publication | Obtained. | PMC10017559 | ||
References | PMC10017559 | |||
Summary | Contributed equally and are co-first authorsContributed equally and are joint last authorsMembers are listed in the | PMC10682370 | ||
Background | VIRUS, INFLUENZA | The live-attenuated influenza virus vector-based intranasal SARS-CoV-2 vaccine (dNS1-RBD, Pneucolin; Beijing Wantai Biological Pharmacy Enterprise, Beijing, China) confers long-lasting and broad protection in animal models and is, to our knowledge, the first COVID-19 mucosal vaccine to enter into human trials, but its ... | PMC10682370 | |
Methods | ASYMPTOMATIC SARS-COV-2 INFECTION, DISEASE, CAVITY | We did a multicentre, randomised, double-blind, placebo-controlled, adaptive design, phase 3 trial at 33 centres (private or public hospitals, clinical research centres, or Centre for Disease Control and Prevention) in four countries (Colombia, Philippines, South Africa, and Viet Nam). Men and non-pregnant women (aged ... | PMC10682370 | |
Findings | deaths, rhinorrhoea, headache | ADVERSE REACTIONS, ASYMPTOMATIC SARS-COV-2 INFECTION, ADVERSE EVENTS, MAY, ADVERSE REACTION | Between Dec 16, 2021, and May 31, 2022, 41 620 participants were screened for eligibility and 31 038 participants were enrolled and randomly assigned (15 517 in the vaccine group and 15 521 in the placebo group). 30 990 participants who received at least one dose (15 496 vaccine and 15 494 placebo) were included in the... | PMC10682370 |
Interpretation | Although this trial did not meet the predefined efficacy criteria for success, dNS1-RBD was well tolerated and protective against omicron variants, both as a primary immunisation and as a heterologous booster. | PMC10682370 | ||
Funding | Beijing Wantai Biological Pharmacy Enterprise, National Science and Technology Major Project, National Natural Science Foundation of China, Fujian Provincial Science and Technology Plan Project, Natural Science Foundation of Fujian Province, Xiamen Science and Technology Plan Special Project, Bill & Melinda Gates Found... | PMC10682370 | ||
Research in context | respiratory infectious diseases | CORONAVIRUS, VIRUS, ADVERSE EVENT, INFLUENZA |
We searched PubMed for clinical trials published from database inception to June 27, 2023, with the following terms: “(intranasal OR nasal OR mucosal OR aerosolized OR inhaled) AND (coronavirus OR COVID-19 OR SARS-CoV-2) AND (vaccine) AND (clinical trial)”. No language restrictions were applied. In addition to dNS1-RB... | PMC10682370 |
Introduction | infections, respiratory mucosal SARS-CoV-2 vaccine | DISEASE, INFECTIONS | SARS-CoV-2 omicron sublineages have shown a strong ability to evade neutralising antibodies because of their continuous evolution.Although evidence indicates that a booster dose of existing SARS-CoV-2 vaccines provides sustained protection against severe disease or hospitalisation caused by omicron variants, the effect... | PMC10682370 |
Methods | PMC10682370 | |||
Study design and participants | DISEASE | This multicentre, randomised, double-blind, placebo-controlled, case-driven, and adaptive design phase 3 trial was done at 33 sites (private or public hospitals, clinical research centres, or Center for Disease Control and Prevention) in Colombia, the Philippines, South Africa, and Viet Nam (Participants in South Afric... | PMC10682370 | |
Randomisation and masking | All enrolled participants were randomly assigned (1:1) to receive two doses of either the dNS1-RBD vaccine or placebo. Block randomisation was done at each study centre by trained blinded investigators using an interactive web-response system, stratified according to centre, age group (18–59 years or ≥60 years), and th... | PMC10682370 | ||
Procedures | sore throat, nausea or vomiting, diarrhoea, myalgia, delirium, fatigue, fever, dysfunction of arousal and content); (2), dementia, cough, loss of taste or smell, rhinitis, infection, coma, headache, depression, shortness of breath | SORE THROAT, SARS-COV-2 INFECTION, LACK OF APPETITE, ADVERSE EVENTS, ASYMPTOMATIC SARS-COV-2 INFECTION, INFECTION, RHINITIS, ADVERSE EVENT, COMA, EVENTS | The vaccine dNS1-RBD was a liquid preparation, containing 1 × 10All participants were observed for at least 30 min after vaccination for any acute reactions and were trained to record any local and systemic events using a diary card. Monitoring for adverse events included spontaneous reporting from participants and tel... | PMC10682370 |
Outcomes | deaths, clear chronic disease | ADVERSE EVENTS, ADVERSE EVENT, ASYMPTOMATIC SARS-COV-2 INFECTION, SECONDARY | The specific details regarding the safety and efficacy analyses were prespecified in the statistical analysis plan (version 2.0, dated Dec 6, 2022), which was finalised before data locking. The primary safety endpoints were solicited adverse events and reactions occurring within 7 days of either dose; adverse events an... | PMC10682370 |
Statistical analysis | ADVERSE EVENTS, DISEASE | In accordance with the 2020 WHO guidelines,The originally planned interim analysis was scheduled to be done when the number of individuals for the primary efficacy endpoint reached 75 (The safety data were collected for 12 months after the final dose (ie, safety observation period; completed on June 30, 2023), whereas ... | PMC10682370 | |
Role of the funding source | The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. | PMC10682370 | ||
Results | infection, rhinorrhoea | ADVERSE REACTIONS, ADVERSE EVENTS, ADVERSE EVENT, DISEASE, ASYMPTOMATIC SARS-COV-2 INFECTION, MAY, INFECTION, BLIND | Between Dec 16, 2021, and May 31, 2022, 41 620 participants were screened for eligibility, of whom 31 038 were enrolled and randomly assigned (17 210 with a history of SARS-CoV-2 vaccination and 13 828 without; 15 517 in the vaccine group and 15 521 in the placebo group). 30 990 participants received at least one dose ... | PMC10682370 |
Discussion | infection, death, –27·7, pain | VIRUS, ASYMPTOMATIC SARS-COV-2 INFECTION, DISEASE, INFECTION, DISEASES, INFLUENZA | To our knowledge, this study is the first report on the efficacy of a mucosal SARS-CoV-2 vaccine in a large-scale phase 3 trial. The favourable safety profile observed in early phase clinical trialsCompared with parenteral injection, intranasal vaccination offers the advantages of being needle-free and non-invasive, th... | PMC10682370 |
Data sharing | The study protocol is available for review. The data in this Article will be available after publication and finalisation of the complete clinical study report for at least 6 months. Researchers who provide a scientifically sound proposal will be allowed to access the de-identified individual participant data. Proposal... | PMC10682370 | ||
Declaration of interests | JJ | JT, JJ, and XC were employees of Beijing Wantai Biological Pharmacy Enterprise during the conduct of the study. JH and XY are employees of and have stock options in Beijing Wantai Biological Pharmacy Enterprise. All other authors declare no competing interests. | PMC10682370 | |
References | PMC10682370 | |||
Supplementary Material | PMC10682370 | |||
Supplementary appendix | PMC10682370 | |||
Acknowledgments | This study was funded by Beijing Wantai Biological Pharmacy Enterprise, and was also funded by the National Science and Technology Major Project (2020YFC0842600), the National Natural Science Foundation of China (82041038), the Fujian Provincial Science and Technology Plan Project (2020YZ014001 and 2022L3081), the Natu... | PMC10682370 | ||
Contributors | JJ | TW, JZ, and NX made the development plan of the vaccine, designed the study protocol, and monitored the trial. FZ was the global principal investigator of this trial. AMJ, THD, JGP, AGD, LST, GMAZ, REMV, GPG, LLGB, and SPIP were the principal investigator of each site and managed the participants. SH, XL, QC, CZ, JH, J... | PMC10682370 | |
Abstract | PMC10417173 | |||
Background | breast cancer | DISEASE, BREAST CANCER | Patients' lack of knowledge about their own disease may function as a barrier to shared decision‐making and well‐being. This study aimed to evaluate the impact of written educational materials on breast cancer patients. | PMC10417173 |
Methods | BREAST CANCER DIAGNOSIS | This multicenter, parallel, unblinded, randomized trial included Latin American women aged ≥18 years with a recent breast cancer diagnosis yet to start systemic therapy. Participants underwent randomization in a 1:1 ratio to receive a customizable or standard educational brochure. The primary objective was accurate ide... | PMC10417173 | |
Results | breast cancer | DISEASE, BREAST CANCER | One hundred sixty‐five breast cancer patients with a median age of 53 years and 61 days from diagnosis were included (customizable: 82; standard: 83). At first available assessment, 52%, 48%, and 30% identified their molecular subtype, disease stage, and guideline‐endorsed systemic treatment strategy, respectively. Acc... | PMC10417173 |
Conclusions | breast cancer | DISEASE CHARACTERISTIC, BREAST CANCER | Over one third of recently diagnosed breast cancer patients are incognizant of their disease characteristics and treatment options. This study demonstrates a need to improve patient education and shows that customizable educational materials increase patients' understanding of recommended systemic therapies according t... | PMC10417173 |
INTRODUCTION | tumor, breast cancer | DISEASE, TUMOR, BREAST CANCER | Optimal treatment strategies and prognosis of breast cancer are largely dictated by three variables: molecular subtype, disease stage, and patient preferences.Limited data have been published regarding the knowledge level of breast cancer patients about their diagnosis. It has been reported that 13%–65% of patients do ... | PMC10417173 |
MATERIALS AND METHODS | PMC10417173 | |||
Patient selection | intellectual disability | DEL, BREAST CANCER DIAGNOSIS, RECRUITMENT | This study is a parallel‐arm, multicenter, international, unblinded, randomized clinical trial. Women aged ≥18 years with a recent breast cancer diagnosis (i.e., <6 months) who were yet to start systemic therapy (i.e., chemotherapy, hormone therapy, anti‐HER2 agents, and immunotherapy) were eligible to participate if t... | PMC10417173 |
Educational brochures | cancer, breast cancer | CANCER, BREAST CANCER | Educational brochures were developed by a multidisciplinary team comprised of a medical oncologist and a surgeon specialized in breast cancer, two clinical researchers, and a group of graphic designers with experience in educational materials for oncologic patients. Team members performed a pilot of the customizable br... | PMC10417173 |
Follow‐up | DISEASE | Patients who consented to participate were asked to complete seven questionnaires either in‐person, by telephone, or email. Study coordinators were instructed not to suggest whether or how participants might use the brochure while answering study surveys. Three of the questionnaires were answered 7–21 days after having... | PMC10417173 | |
Statistical analysis | DEL | All analyses were performed using R statistical (version 4.1.0, R Project for Statistical Computing) and RStudio (version 1.4.1717, R Foundation for Statistical Computing) software. Descriptive statistics were undertaken using frequency and proportions for categorical variables, and median and 95% confidence interval (... | PMC10417173 | |
RESULTS | PMC10417173 | |||
Participant characteristics | A total of 205 consecutive patients were eligible to participate (Figure Participant flow diagram.Table Sociodemographic and clinical characteristics of participants.
Abbreviations: HER2, human epidermal growth factor receptor 2; HLS‐EU‐Q16, European Health Literacy Survey Questionnaire, short version; HR, hormone rece... | PMC10417173 | ||
Participant knowledge regarding breast cancer | REGRESSION, DISEASE, DISEASE CHARACTERISTIC | Participants' knowledge about their diagnosis and guideline‐recommended therapy was evaluated twice. A total of 141 patients completed the survey at the first prespecified timepoint after a median of 18 days (95% CI 15–19) since randomization and receipt of their corresponding brochure. One hundred forty‐nine participa... | PMC10417173 | |
Participant satisfaction with the educational brochure | In terms of satisfaction with the brochure received, the only statistically significant difference observed was in perception that the brochure helped patients participate in treatment decisions (patients who selected “strongly agree” in the customizable brochure group: 60% vs. standard: 42%, Participant satisfaction w... | PMC10417173 | ||
DISCUSSION | tumor, breast cancer | TUMOR, BREAST CANCER, AIDS, DISEASE, DISEASE CHARACTERISTIC | In this study, approximately half of recently diagnosed, Latin American breast cancer patients were able to correctly identify their disease stage or molecular subtype. Furthermore, only one third of participants identified which systemic treatments were recommended according to their individual tumor characteristics. ... | PMC10417173 |
CONCLUSION | tumor, breast cancer | DISEASE, TUMOR, BREAST CANCER | In conclusion, a high proportion of recently diagnosed Latin American breast cancer patients remain oblivious to tumor characteristics such as molecular subtype and disease stage despite having received written educational materials. Both a customizable educational brochure and a standard, non‐customizable brochure wer... | PMC10417173 |
AUTHOR CONTRIBUTIONS | PMC10417173 | |||
FUNDING INFORMATION | This work was supported by Roche Mexico. | PMC10417173 | ||
CONFLICT OF INTEREST STATEMENT | C.V.G | ONCOLOGY | C.V.G: Reports grants, personal fees, and non‐financial support from AstraZeneca; grants, personal fees, and non‐financial support from Roche; personal fees and non‐financial support from MSD Oncology; personal fees and non‐financial support from Pfizer; non‐financial support from Novartis; and personal fees from Eli L... | PMC10417173 |
Supporting information |
Figure S1.
Click here for additional data file.
Figure S2.
Click here for additional data file.
Figure S3.
Click here for additional data file. | PMC10417173 | ||
ACKNOWLEDGMENTS | ALBERT | The authors thank Fundacion Mexicana Para la Salud (FUNSALUD), A.C. for their administrative role and Natalia Villarreal Cadena for her role in the design of the educational materials. The authors thank Ofelia Fernanda Aguiñaga‐Orozco, Calixto Camacho‐Rodriguez, Ana Maria Casillas‐Villarreal, Daniel Motola‐Kuba, Celest... | PMC10417173 | |
DATA AVAILABILITY STATEMENT | N/A. | PMC10417173 | ||
REFERENCES | PMC10417173 | |||
Abstract | PMC10603557 | |||
Introduction | HIV controllers have low viral loads (VL) without antiretroviral treatment (ART). We evaluated viraemic control in a community‐randomized trial conducted in Zambia and South Africa that evaluated the impact of a combination prevention intervention on HIV incidence (HPTN 071 [PopART]; 2013–2018). | PMC10603557 | ||
Methods | VL and antiretroviral (ARV) drug testing were performed using plasma samples collected 2 years after enrolment for 4072 participants who were HIV positive at the start of the study intervention. ARV drug use was assessed using a qualitative laboratory assay that detects 22 ARV drugs in five drug classes. Participants w... | PMC10603557 | ||
Results | The final cohort included 126 viraemic controllers and 766 non‐controllers who had no ARV drugs detected. The prevalence of controllers among the 4072 persons assessed was 3.1% (95% confidence interval [CI]: 2.6%, 3.6%). This should be considered a minimum estimate, since high rates of ARV drug use in the parent study ... | PMC10603557 | ||
Conclusions | To our knowledge, this report presents the first large‐scale, population‐level study evaluating the prevalence of viraemic control and associated factors in Africa. A key advantage of this study was that a biomedical assessment was used to assess ARV drug use (vs. self‐reported data). This study identified a large coho... | PMC10603557 | ||
INTRODUCTION | HIV infection | HIV INFECTION | HIV controllers naturally suppress their HIV viral load (VL) to low levels without antiretroviral treatment (ART) [Previous population‐level studies have reported the prevalence of elite and viraemic controllers as <1% [In this report, we evaluated factors associated with viraemic control in a community‐randomized tria... | PMC10603557 |
METHODS | PMC10603557 | |||
Study cohort | This research was conducted using samples and data collected in the HPTN 071 (PopART) trial (NCT019000977; 2013–2018) [ | PMC10603557 | ||
Laboratory methods | Herpes simplex | VIRUS, HERPES SIMPLEX | Herpes simplex virus type 2 (HSV‐2) testing was performed at study sites using the Kalon HSV2 immunoglobulin G enzyme‐linked immunosorbent assay (ELISA; Kalon Biological), as described [ | PMC10603557 |
Statistical methods | Participants classified as viraemic controllers had VLs <2000 copies/ml with no ARV drugs detected at two annual study visits. This classification approach is consistent with methods described in previous reports [ | PMC10603557 | ||
Informed consent | Study participants provided written informed consent prior to enrolment in HPTN 071, which was approved by the institutional review board and ethics committees at the London School of Hygiene and Tropical Medicine, the University of Zambia and Stellenbosch University. | PMC10603557 | ||
RESULTS | herpes simplex | VIRUS, HERPES SIMPLEX | HPTN 071 included 4101 participants who were HIV positive at the start of the study intervention (PC0) and had a sample stored 2 years later (PC24; Figure Identification of viraemic controllers and non‐controllers in HPTN 071 (PopART). The figure shows the approach used to identify viraemic controllers and non‐controll... | PMC10603557 |
DISCUSSION | HIV infection, infections | HIV INFECTION, INFECTIONS | To our knowledge, this report presents the first large‐scale, multisite, population‐level study evaluating the prevalence of viraemic control and associated factors in Africa. The study was conducted in a generalized epidemic setting in two sub‐Saharan African countries and included men and women from urban and peri‐ur... | PMC10603557 |
CONCLUSIONS | The prevalence of viraemic control in this population‐based study was 3.1%. Viraemic control was associated with biological sex (women > men). This study identified a large cohort of controllers and non‐controllers. Further characterization of this cohort may provide insights into the mechanisms of HIV control. | PMC10603557 | ||
COMPETING INTERESTS | None of the authors has competing interests or potential competing interests. | PMC10603557 | ||
AUTHORS’ CONTRIBUTIONS | WG‐M: designed the study, performed laboratory testing, analysed data and drafted the manuscript; EP‐M: HPTN 071 LC QA/QC Representative; WC: responsible for antiretroviral drug testing; AB: performed antiretroviral drug testing; KBZ: assisted with data management; AM: HPTN 071 Study Coordinator; HMA: HPTN 071 Zambia S... | PMC10603557 | ||
FUNDING | AIDS | INFECTIOUS DISEASES, ALLERGY, AIDS, ABUSE, EMERGENCY | This work was supported by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) through R01‐AI095068, the National Institute of General Medical Sciences (NIGMS) through R01‐GM136724 and by the HIV Prevention Trials Network (HPTN), which is sponsored by the NIAID u... | PMC10603557 |
DISCLAIMER | The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIAID, NIMH, NIDA, PEPFAR, 3ie or the Bill & Melinda Gates Foundation. | PMC10603557 | ||
ACKNOWLEDGEMENTS | The authors thank Joel Blankson for his critical review of the manuscript, the HPTN 071 (PopART) study participants for their participation, and the laboratory staff at the study sites and the HPTN Laboratory Center for their assistance with sample processing and testing. | PMC10603557 | ||
DATA AVAILABILITY STATEMENT | The data sets used and/or analysed during the current study are available from the corresponding author on reasonable request. | PMC10603557 | ||
REFERENCES | PMC10603557 | |||
Background: | OBESE | Difficult peripheral venous access, especially in obese people, is challenging for novices. We conducted a randomized cross-over study to examine whether near-infrared venous imaging or ultrasound guidance is more useful for novice operators to obtain difficult peripheral venous access. | PMC10036034 | |
Methods: | SECONDARY, OBESE | Medical students were recruited as participants. After receiving basic training using commercial simulators, participants were randomly assigned to obtain simulated venous access using a difficult venous access simulator with near-infrared venous imaging or ultrasound guidance in a randomized cross-over design. A diffi... | PMC10036034 | |
Results: | Forty-one medical students with no experience performing peripheral venous access were enrolled in this study. The rate of successful first attempts did not differ between the 2 groups (70% for near-infrared; 65% for ultrasound guidance; | PMC10036034 | ||
Conclusion: | obese | OBESE | There was no difference in success rate of first-time attempts or acquiring proficiency for the 2 methods. However, duration of the first attempt was significantly shorter with near-infrared imaging than with ultrasound guidance. Near-infrared imaging may require less training than ultrasound guidance. Near-infrared ve... | PMC10036034 |
1. Introduction | Obesity | OBESITY | Peripheral venous catheters are the most commonly used devices for vascular access in routine clinical practice. Obesity is associated with difficult peripheral venous access. | PMC10036034 |
2. Materials and methods | RECRUITMENT | The present study was approved by the Faculty of Medicine Research Ethics Committee, Kyorin University (approval number 1804) and registered in the University Hospital Medical Information Network Center Clinical Registration System (UMIN000045269). The study was conducted in accordance with Consolidated Standards of Re... | PMC10036034 | |
2.1. Simulation training | Before starting the study, simulation training was conducted. The Intravenous ARM III (Kyoto Kagaku Co., Japan) simulator was used to train the direct visual and palpation techniques for peripheral venous access for 30 minutes. The peripheral venous catheter was BD Insight 22G, 25 mm (Nippon Becton Dickinson Co., Japan... | PMC10036034 | ||
2.2. Difficult venous access simulator | SECONDARY | A simulator was developed especially for this study (Kyoto Kagaku Co., Japan) (Fig. Difficult venous access simulator. (a) Simulated vessels cannot be seen in the simulator with the eye. (b) Near-infrared imaging with the simulator, allowing 1 to see simulated vessels. (c) Ultrasound imaging with the simulator providin... | PMC10036034 | |
2.3. Statistical analysis | Success rates were expressed as percentages (%). Procedure times (seconds) and number of 3 consecutive successes were shown as median (first quartile, third quartile). The presence or absence of carryover effects was evaluated with the Mann–Whitney | PMC10036034 | ||
2.4. Power analysis | At the time the present study began, there were no comparative studies comparing near-infrared vein imaging and ultrasound guidance in adult patients. The clinical difference between the 2 techniques could not be determined. Therefore, assuming a clinically significant difference, the sample size required for 80% power... | PMC10036034 | ||
3. Results | fatigue | Forty-one medical students participated in the present study. One participant data was excluded due to missing data (refusal to continue participation due to fatigue, Fig. CONSORT diagram. CONSORT = consolidated standards of reporting trials. | PMC10036034 |
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