scholarly journals An automated retrospective VAE-surveillance tool for future quality improvement studies

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Oliver Wolffers ◽  
Martin Faltys ◽  
Janos Thomann ◽  
Stephan M. Jakob ◽  
Jonas Marschall ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Incidence Rate ◽  
Gold Standard ◽  
Large Data ◽  
University Hospital ◽  
Data Management System ◽  
Tertiary Referral Center ◽  
Infectious Origin ◽  
Baseline Incidence ◽  
Automated Surveillance

AbstractVentilator-associated pneumonia (VAP) is a frequent complication of mechanical ventilation and is associated with substantial morbidity and mortality. Accurate diagnosis of VAP relies in part on subjective diagnostic criteria. Surveillance according to ventilator-associated event (VAE) criteria may allow quick and objective benchmarking. Our objective was to create an automated surveillance tool for VAE tiers I and II on a large data collection, evaluate its diagnostic accuracy and retrospectively determine the yearly baseline VAE incidence. We included all consecutive intensive care unit admissions of patients with mechanical ventilation at Bern University Hospital, a tertiary referral center, from January 2008 to July 2016. Data was automatically extracted from the patient data management system and automatically processed. We created and implemented an application able to automatically analyze respiratory and relevant medication data according to the Centers for Disease Control protocol for VAE-surveillance. In a subset of patients, we compared the accuracy of automated VAE surveillance according to CDC criteria to a gold standard (a composite of automated and manual evaluation with mediation for discrepancies) and evaluated the evolution of the baseline incidence. The study included 22′442 ventilated admissions with a total of 37′221 ventilator days. 592 ventilator-associated events (tier I) occurred; of these 194 (34%) were of potentially infectious origin (tier II). In our validation sample, automated surveillance had a sensitivity of 98% and specificity of 100% in detecting VAE compared to the gold standard. The yearly VAE incidence rate ranged from 10.1–22.1 per 1000 device days and trend showed a decrease in the yearly incidence rate ratio of 0.96 (95% CI, 0.93–1.00, p = 0.03). This study demonstrated that automated VAE detection is feasible, accurate and reliable and may be applied on a large, retrospective sample and provided insight into long-term institutional VAE incidences. The surveillance tool can be extended to other centres and provides VAE incidences for performing quality control and intervention studies.

scholarly journals Development of a customised data management system for a COVID-19-adapted colorectal cancer pathway

2021 ◽  
Vol 28 (1) ◽  
pp. e100307
Author(s):  
Janice Miller ◽  
Frances Gunn ◽  
Malcolm G Dunlop ◽  
Farhat VN Din ◽  
Yasuko Maeda
Keyword(s):  
Colorectal Cancer ◽  
Data Management ◽  
Management System ◽  
Data Entry ◽  
Large Data ◽  
Data Management System ◽  
Volume Data ◽  
Visual Basic For Applications ◽  
Resource Limited ◽  
Data Definition

ObjectivesA customised data management system was required for a rapidly implemented COVID-19-adapted colorectal cancer pathway in order to mitigate the risks of delayed and missed diagnoses during the pandemic. We assessed its performance and robustness.MethodsA system was developed using Microsoft Excel (2007) to retain the spreadsheets’ intuitiveness of direct data entry. Visual Basic for Applications (VBA) was used to construct a user-friendly interface to enhance efficiency of data entry and segregate the data for operational tasks.ResultsLarge data segregation was possible using VBA macros. Data validation and conditional formatting minimised data entry errors. Computation by the COUNT function facilitated live data monitoring.ConclusionIt is possible to rapidly implement a makeshift database system with clinicians’ regular input. Large-volume data management using a spreadsheet system is possible with appropriate data definition and VBA-programmed data segregation. The described concept is applicable to any data management system construction requiring speed and flexibility in a resource-limited situation.

scholarly journals A multicenter randomized trial to assess the efficacy of CONvalescent plasma therapy in patients with Invasive COVID-19 and acute respiratory failure treated with mechanical ventilation: the CONFIDENT trial protocol

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Benoît Misset ◽  
Eric Hoste ◽  
Anne-Françoise Donneau ◽  
David Grimaldi ◽  
Geert Meyfroidt ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Respiratory Failure ◽  
Neutralizing Antibodies ◽  
Ethical Issues ◽  
High Titer ◽  
Passive Immunization ◽  
University Hospital ◽  
Optimal Time ◽  
Relative Reduction ◽  
Number Of Patients

Abstract Background The COVID-19 pandemic reached Europe in early 2020. Convalescent plasma is used without a consistent evidence of efficacy. Our hypothesis is that passive immunization with plasma collected from patients having contracted COVID-19 and developed specific neutralizing antibodies may alleviate symptoms and reduce mortality in patients treated with mechanical ventilation for severe respiratory failure during the evolution of SARS-CoV-2 pneumonia. Methods We plan to include 500 adult patients, hospitalized in 16 Belgian intensive care units between September 2020 and 2022, diagnosed with SARS-CoV-2 pneumonia, under mechanical ventilation for less than 5 days and a clinical frailty scale less than 6. The study treatment will be compared to standard of care and allocated by randomization in a 1 to 1 ratio without blinding. The main endpoint will be mortality at day 28. We will perform an intention to treat analysis. The number of patients to include is based on an expected mortality rate at day 28 of 40 percent and an expected relative reduction with study intervention of 30 percent with α risk of 5 percent and β risk of 20 percent. Discussion This study will assess the efficacy of plasma in the population of mechanically ventilated patients. A stratification on the delay from mechanical ventilation and inclusion will allow to approach the optimal time use. Selecting convalescent plasmas with a high titer of neutralizing antibodies against SARS-CoV-2 will allow a homogeneous study treatment. The inclusion in the study is based on the consent of the patient or his/her legal representative, and the approval of the Investigational Review Board of the University hospital of Liège, Belgium. A data safety monitoring board (DSMB) has been implemented. Interim analyses have been planned at 100, 2002, 300 and 400 inclusions in order to decide whether the trail should be discontinued prematurely for ethical issues. We plan to publish our results in a peer-reviewed journal and to present them at national and international conferences. Funding and registration The trial is funded by the Belgian Health Care Knowledge Center KCE # COV201004 Trial registration Clinicaltrials.gov registration number NCT04558476. Registered 14 September 2020—Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04558476

scholarly journals COVIDENZA - A prospective, multicenter, randomized PHASE II clinical trial of enzalutamide treatment to decrease the morbidity in patients with Corona virus disease 2019 (COVID-19): a structured summary of a study protocol for a randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Karin Welén ◽  
Anna K Överby ◽  
Clas Ahlm ◽  
Eva Freyhult ◽  
David Robinsson ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Virus Disease ◽  
Controlled Trial ◽  
Scale Up ◽  
Standard Of Care ◽  
University Hospital ◽  
Ordinal Scale ◽  
Open Label ◽  
Full Protocol ◽  
Exploration Phase

Abstract Objectives The main goal of the COVIDENZA trial is to evaluate if inhibition of testosterone signalling by enzalutamide can improve the outcome of patients hospitalised for COVID-19. The hypothesis is based on the observation that the majority of patients in need of intensive care are male, and the connection between androgen receptor signalling and expression of TMPRSS2, an enzyme important for SARS-CoV-2 host cell internalization. Trial design Hospitalised COVID-19 patients will be randomised (2:1) to enzalutamide plus standard of care vs. standard of care designed to identify superiority. Participants Included participants, men or women above 50 years of age, must be hospitalised for PCR confirmed COVID-19 symptoms and not in need of immediate mechanical ventilation. Major exclusion criteria are breast-feeding or pregnant women, hormonal treatment for prostate or breast cancer, treatment with immunosuppressive drugs, current symptomatic unstable cardiovascular disease (see Additional file 1 for further details). The trial is registered at Umeå University Hospital, Region Västerbotten, Sweden and 8 hospitals are approved for inclusion in Sweden. Intervention and comparator Patients randomised to the treatment arm will be treated orally with 160 mg (4x40 mg) enzalutamide (Xtandi®) daily, for five consecutive days. The study is not placebo controlled. The comparator is standard of care treatment for patients hospitalised with COVID-19. Main outcomes The primary endpoints of the study are (time to) need of mechanical ventilation or discharge from hospital as assessed by a clinical 7-point ordinal scale (up to 30 days after inclusion). Randomisation Randomisation was stratified by center and sex. Each strata was randomized separately with block size six with a 2:1 allocation ratio (enzalutamide + “standard of care”: “standard of care”). The randomisation list, with consecutive subject numbers, was generated by an independent statistician using the PROC PLAN procedure of SAS version 9.4 software (SAS Institute, Inc, Cary, North Carolina) Blinding (masking) This is an open-label trial. Numbers to be randomised (sample size) The trial is designed to have three phases. The first, an exploration phase of 45 participants (30 treatment and 15 control) will focus on safety and includes a more extensive laboratory assessment as well as more frequent safety evaluation. The second prolongation phase, includes the first 100 participants followed by an interim analysis to define the power of the study. The third phase is the continuation of the study up to maximum 600 participants included in total. Trial Status The current protocol version is COVIDENZA v2.0 as of September 10, 2020. Recruitment started July 29, 2020 and is presently in safety pause after the first exploration phase. Recruitment is anticipated to be complete by 31 December 2021. Trial registration Eudract number 2020-002027-10 ClinicalTrials.gov Identifier: NCT04475601, registered June 8, 2020 Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

scholarly journals 832. Assessment of Risk Factors Associated with Wide-resistance Gram-negative Bacteria Infections

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S457-S457
Author(s):  
Henry Pablo Lopes Campos e Reis ◽  
Ana Beatriz Ferreira Rodrigues ◽  
Julio César Castro Silva ◽  
Lia Pinheiro de Lima ◽  
Talita Lima Quinaher ◽  
...  
Keyword(s):  
Risk Factors ◽  
Mechanical Ventilation ◽  
Univariate Analysis ◽  
Multidrug Resistant ◽  
University Hospital ◽  
Gram Negative Bacteria ◽  
Multiresistant Pathogens ◽  
Gram Negative ◽  
Contact Isolation ◽  
Bladder Catheter

Abstract Background Enterobacteria and multidrug-resistant non-fermenting Gram-negative bacilli present a challenge in the management of invasive infections, leading to mortality rates due to their limited therapeutic arsenal. The objective of this work was to analyze risk factors that may be associated with these infections, for a better situational mapping and assertive decision-making in a university hospital in Brazil. Methods The study was conducted between January and September 2019, with 167 patients in contact isolation at a university hospital in Brazil. Potential outcome-related variables for wide-resistance Gram-negative bacteria (BGN) infections were evaluated. Risk factors were identified from univariate statistical analysis using Fisher’s test. Results 51 (30.5%) out of 167 patients in contact isolation evolved with wide-resistance BGN infection. Risk factors in univariate analysis were age, hospital unit and previous use of invasive devices. Patients aged up to 59 years were more likely to progress to infection than those aged over 60 years (p 0.0274, OR 2.2, 95% CI 1.1-4.5). Those admitted to the oncohematology (p < 0.001, OR 32.5, Cl 9.1-116.3) and intensive care unit (p < 0.001, OR 28.0, Cl 3.5-225.9) units were more likely to develop this type of infection. The least likely were those admitted to a kidney transplant unit (p 0.0034, OR 15.33, Cl 1.8-131.0). Prior use of mechanical ventilation (p 0.0058, OR 12.2, Cl 2.0-76.1) and delayed bladder catheter (p 0.0266, OR 5.0, Cl 1.2-20.1) in patients with respiratory and urinary tract infection, respectively, were also reported as risk factors related to these infections. The gender of the patients was not significant for the study. Conclusion This study determined that variables such as age, hospitalization unit, use of mechanical ventilation and delayed bladder catheter could be considered important risk factors in triggering the infectious process by wide-resistant gram-negative bacteria. Thus, the analysis of these factors becomes a great foundation to prevent the development of multiresistant pathogens through prevention strategies, prophylaxis management and more targeted empirical therapies. Disclosures All Authors: No reported disclosures

scholarly journals Validation of a Next-Generation Sequencing Assay Targeting RNA for the Multiplexed Detection of Fusion Transcripts and Oncogenic Isoforms

2019 ◽  
Vol 144 (1) ◽  
pp. 90-98 ◽  
Author(s):  
Robyn T. Sussman ◽  
Amanda R. Oran ◽  
Carmela Paolillo ◽  
David Lieberman ◽  
Jennifer J. D. Morrissette ◽  
...  
Keyword(s):  
Next Generation Sequencing ◽  
Solid Tumors ◽  
Gold Standard ◽  
University Hospital ◽  
Fusion Partner ◽  
Next Generation ◽  
Fixed Tissue ◽  
Fusion Transcripts ◽  
Genetic Abnormalities ◽  
Generation Sequencing

Context.— Next-generation sequencing is a high-throughput method for detecting genetic abnormalities and providing prognostic and therapeutic information for patients with cancer. Oncogenic fusion transcripts are among the various classifications of genetic abnormalities present in tumors and are typically detected clinically with fluorescence in situ hybridization (FISH). However, FISH probes only exist for a limited number of targets, do not provide any information about fusion partners, cannot be multiplex, and have been shown to be limited in specificity for common targets such as ALK. Objective.— To validate an anchored multiplex polymerase chain reaction–based panel for the detection of fusion transcripts in a university hospital–based clinical molecular diagnostics laboratory. Design.— We used 109 unique clinical specimens to validate a custom panel targeting 104 exon boundaries from 17 genes involved in fusions in solid tumors. The panel can accept as little as 100 ng of total nucleic acid from PreservCyt-fixed tissue, and formalin-fixed, paraffin-embedded specimens with as little as 10% tumor nuclei. Results.— Using FISH as the gold standard, this assay has a sensitivity of 88.46% and a specificity of 95.83% for the detection of fusion transcripts involving ALK, RET, and ROS1 in lung adenocarcinomas. Using a validated next-generation sequencing assay as the orthogonal gold standard for the detection of EGFR variant III (EGFRvIII) in glioblastomas, the assay is 92.31% sensitive and 100% specific. Conclusions.— This multiplexed assay is tumor and fusion partner agnostic and will provide clinical utility in therapy selection for patients with solid tumors.

Intraductal Fragmentation in Sialolithiasis Using Pneumatic Lithotripsy: Initial Experience and Results

2021 ◽  
pp. 019459982110512
Author(s):  
Michael Koch ◽  
Mirco Schapher ◽  
Matti Sievert ◽  
Konstantinos Mantsopoulos ◽  
Heinrich Iro
Keyword(s):  
Multimodal Therapy ◽  
University Hospital ◽  
Single Frequency ◽  
Operating Pressure ◽  
Initial Experience ◽  
Clinical Factors ◽  
Tertiary Referral ◽  
Stone Size ◽  
Tertiary Referral Center ◽  
Increased Risk

Objective To report initial experience in using a pneumatic lithotripter to treat salivary stones. Study Design Level IV retrospective study. Setting University hospital and tertiary referral center. Methods A pneumatic lithotripter was used to treat salivary stones after these were diagnosed. Probes with diameters of 0.7 mm were used. Total fragmentation was intended in all stones. Stone fragments were removed using several instruments in serial sialendoscopies to achieve complete stone clearance. Results A total of 62 patients with 77 stones were treated. Forty-three submandibular stones were treated in 34 patients, and 34 parotid stones were treated in 28 patients. An operating pressure of 2.5 bar and a single frequency mode were used. Complete fragmentation was achieved in all but one of the treated stones in both glands (98.7%). Among the patients, 90.32% became stone free and 100% symptom free. Multiple stones were treated in 24.19% of the patients, and multimodal therapy was also carried out in 24.19%. All of the glands were preserved. Conclusions The pneumatic lithotripter proved to be effective in the treatment of sialolithiasis. Stone size, location, and the gland involved were important clinical factors. The device was sufficient to achieve success without any increased risk for complications in the patients or damage to the sialendoscopes.

scholarly journals Urinary N-telopeptide- A diagnostic Test or A Screening Test?

2019 ◽  
Vol 10 (2) ◽  
pp. 1298-1301
Author(s):  
Ganesan G Ram ◽  
Jambu N
Keyword(s):  
Diagnostic Test ◽  
Roc Curve ◽  
Gold Standard ◽  
Screening Test ◽  
Dual Energy ◽  
University Hospital ◽  
Control Group ◽  
X Ray ◽  
Dexa Scan ◽  
Group I

Dual-energy X-ray absorptiometry (DEXA) scan is the gold standard investigation for diagnosing osteoporosis. The limitations of "gold standard" Dual-energy X-ray absorptiometry scan were many. The aim of this study is to find whether urinary n telopeptide can be used to diagnose osteoporosis — prospective cohort study done at Sri Ramachandra Medical University between August 2014 to December 2018. The study was done amongst the postmenopausal females and older males who came to the University hospital as an inpatient or an outpatient with suspected osteoporosis. We had 110 persons participated in the study. The patients were divided into two groups. Group, I was cases whose Dexa scan was osteoporosis/ osteopenia, and Group II was a control that had standard Dexa. The results from Dexa Scan are taken as the gold standard against urinary n telopeptide and a 2x2 table formed. Sensitivity, specificity, positive predictive value, likelihood ratio, area under ROC curve will be calculated. The mean value of urinary N Telopeptide in the case group was 182.5 and in control group was 49.8. The ROC curve was formed and cut off was calculated to be 71. Urinary N telopeptide can very well be considered as a diagnostic test and can’t be considered as a gold standard diagnostic test as there is some limitation as it is a bone resorption biomarker having some pre-analytical and biochemical variability which can alter the results. It can be used as an adjuvant and as a screening test along with gold standard Dexa in diagnosing osteoporosis.

scholarly journals Impact of Permissive Hypoxia and Hyperoxia Avoidance on Clinical Outcomes in Septic Patients Receiving Mechanical Ventilation: A Retrospective Single-Center Study

2021 ◽  
Vol 2021 ◽  
pp. 1-10
Author(s):  
Kota Nishimoto ◽  
Takeshi Umegaki ◽  
Sayaka Ohira ◽  
Takehiro Soeda ◽  
Natsuki Anada ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
University Hospital ◽  
Icu Mortality ◽  
Respiratory Dysfunction ◽  
Mechanically Ventilated ◽  
Icu Stay ◽  
Ventilation Duration ◽  
Mechanical Ventilation Duration ◽  
Before And After ◽  
Clinical Records

Background. Septic patients often require mechanical ventilation due to respiratory dysfunction, and effective ventilatory strategies can improve survival. The effects of the combination of permissive hypoxia and hyperoxia avoidance for managing mechanically ventilated patients are unknown. This study examines these effects on outcomes in mechanically ventilated septic patients. Methods. In a retrospective before-and-after study, we examined adult septic patients (aged ≥18 years) requiring mechanical ventilation at a university hospital. On April 1, 2017, our mechanical ventilation policy changed from a conventional oxygenation target (SpO2: ≥96%) to more conservative targets with permissive hypoxia (SpO2: 88-92% or PaO2: 60 mmHg) and hyperoxia avoidance (reduced oxygenation for Pa O 2 > 110   mmHg ). Patients were divided into a prechange group (April 2015 to March 2017; n = 83 ) and a postchange group (April 2017 to March 2019; n = 130 ). Data were extracted from clinical records and insurance claims. Using a multiple logistic regression model, we examined the association of the postchange group (permissive hypoxia and hyperoxia avoidance) with intensive care unit (ICU) mortality after adjusting for variables such as Sequential Organ Failure Assessment (SOFA) score and PaO2/FiO2 ratios. Results. The postchange group did not have significantly lower adjusted ICU mortality (0.67, 0.33-1.43; P = 0.31 ) relative to the prechange group. However, there were significant intergroup differences in mechanical ventilation duration (prechange: 11.0 days, postchange: 7.0 days; P = 0.01 ) and ICU stay (prechange: 11.0 days, postchange: 9.0 days; P = 0.02 ). Conclusions. Permissive hypoxia and hyperoxia avoidance had no significant association with reduced ICU mortality in mechanically ventilated septic patients. However, this approach was significantly associated with shorter mechanical ventilation duration and ICU stay, which can improve patient turnover and ventilator access.

scholarly journals The Incidence, Risk Factors, Predictors, and Prognoses of Cytomegalovirus Reactivation in Immunocompetent Mechanical Ventilation Patients: A Prospective Observational Study

2021 ◽  
Author(s):  
Zhihui Zhang ◽  
Xuesong Liu ◽  
Ling Sang ◽  
Sibei Chen ◽  
Zhan Wu ◽  
...  
Keyword(s):  
Risk Factors ◽  
Mechanical Ventilation ◽  
Observational Study ◽  
Prospective Observational Study ◽  
Area Under The Curve ◽  
University Hospital ◽  
Laboratory Findings ◽  
Cytomegalovirus Reactivation ◽  
Cmv Reactivation ◽  
Immunocompetent Patients

Abstract Background: Cytomegalovirus (CMV) reactivation can seriously affect the clinical prognoses of critically ill patients. However, the epidemiology and predictors of CMV in immunocompetent patients with mechanical ventilation are not very clear. Methods: A single-center, prospective observational study (conducted from June 30, 2017 to July 01, 2018) with a follow-up of 90 days (September 29, 2018) that included 71 CMV-seropositive immunocompetent patients with mechanical ventilation at a 37-bed university hospital general intensive care unit (ICU) in China. Routine detection of CMV DNAemia was performed once a week until 28 days (Day1, 7, 14, 21, 28) and serology, laboratory findings, and clinical data were obtained at admission.Results: Among 71 patients, 13 (18.3%) showed CMV reactivation within ICU 28-day admission. The median time to reactivation was 7 days. CMV reactivation was related to various factors, including body weight, body mass index (BMI), sepsis, NT-proBNP, BUN, and Hb levels (P< 0.05). In the multivariate regression model, BMI, Hb level, and sepsis were associated with CMV reactivation patients (P< 0.05). Moreover, the area under the curve (AUC) of BMI, Hb and BMI combined Hb was 0.69, 0.70, 0.76, respectively. The rate of complications, duration of mechanical ventilation, hospitalization expense, length of ICU stay, and 90-day all-cause mortality rate in patients with CMV reactivation was significantly higher than in those without CMV reactivation (P< 0.05).Conclusions: Among immunocompetent patients with mechanical ventilation, the incidence of CMV reactivation was high. CMV reactivation can lead to various adverse prognoses. BMI, Hb, and sepsis were independent risk factors for CMV reactivation. BMI and Hb may predict CMV reactivation.

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