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INTRODUCTION: The operating room (OR) is a high-cost and high-revenue area in a hospital comprising extremely complex process steps to treat patients. The perioperative process quality can be optimized through an efficiency-oriented central OR management based on performance indices. However, during the COVID-19 pandemic with the corresponding OR restrictions, there was a significant nation- and worldwide decline in the performance, which may have a lasting impact. Therefore, we proposed the hypothesis that COVID-19 pandemic-related OR restrictions could reduce operative performance in the long term. METHODS: A retrospective, descriptive analysis of perioperative processing times was conducted exemplarily at the University Hospital Ulm using a pre-post design, examining the corresponding second quarters of 2019 to 2022. In total, n = 18,489 operations with n = 314,313 individual time intervals were analyzed. The statistical analyses included the Kruskal-Wallis test adjusted for multiple testing, and the significance level was set at p < 0.01. RESULTS: The results revealed not only a significant decrease in the case volume by 31% (2020) and 23% (2021) during the COVID-19 crisis years, but also significant time delays in various process steps; e.g. the median patient's OR occupancy time (column time) rose from 65 min (2019) to 87 min (2020) and remained elevated (72 min in 2021 and 74 min in 2022, respectively). Even in 2022, beyond the pandemic, the net anaesthesia time was permanently enhanced by 9 min per case. Furthermore, both, the incision-to-closure time and surgeon attachment time were each significantly prolonged by 7 additional minutes, and the time from the end of anaesthesia to the release of the next patient was extended by 4 min. Selected standardized index operations showed only a trend towards these changes, even with a decrease in the incision-to-closure time over time. CONCLUSION: Overall, long-term changes were found in essential perioperative process times even after retraction of the COVID-19 restrictions, indicating some processual "slow down" after the Covid-19-induced "shut down". Further analyses are needed to determine the appropriate targeted control measures to improve processing times and increase the process quality.
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Personalized health care can be optimized by including patient-reported outcomes. Standardized and disease-specific questionnaires have been developed and are routinely used. These patient-reported outcome questionnaires can be simple paper forms given to the patient to fill out with a pen or embedded in digital devices. Regardless of the format used, they provide a snapshot of the patient's feelings and indicate when therapies need to be adjusted. The advantage of digitizing these questionnaires is that they can be automatically analyzed, and patients can be monitored independently of doctor visits. Although the questions of most clinical patient-reported outcome questionnaires follow defined standards and are evaluated by clinical trials, these standards do not exist for data processing. Interoperable data formats and structures would benefit multilingual and cross-study data exchange. Linking questionnaires to standardized terminologies such as the Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) and Logical Observation Identifiers, Names, and Codes (LOINC) would improve this interoperability. However, linking clinically validated patient-reported outcome questionnaires to clinical terms available in SNOMED CT or LOINC is not as straightforward as it sounds. Here, we report our approach to link patient-reported outcomes from health applications to SNOMED CT or LOINC codes. We highlight current difficulties in this process and outline ways to minimize them.
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Due to several peculiarities the clinical treatment after terror-related mass casualty incidents (TerrorMASCAL) differs from handling a conventional MCI. For this reason, TerrorMASCAL situations should get attention as an own entity in hospitals emergency preparedness and response. Among other challenges hospitals surrounding the emergency area will have to deal with a large amount of non-triaged, non-treated and seriously harmed patients, some of them with unfamiliar and disfiguring injuries. In addition, the hospitals themselves can be endangered as a target of further terrorist attacks. Therefore, security concepts depending on the individual circumstances must be elaborated in consultation with the local police authorities.The incident's clinical management should be put in hands of specially trained in-house institutions. Operational and tactical tasks close to patients ("on site") should be separated from strategic and administrative responsibilities ("in the background"). The function of an "Emergency Operational and Medical Coordinator" (EOMC = ZONK) is installed to manage initial diagnostics and therapy for seriously injured victims by prioritization and scheduling available clinical resources.In order to structure the process of emergency admission for numerous patients a triage- and holding area as well as specific in-house treatment areas for different severities of injury should be set up. The clinical triage should follow a consistent algorithm that is based on the cABCDE approach. It is recommended that this algorithm should be defined in hospitals disaster and emergency planning.Surgical strategies concerning the treatment of terror victims might be oriented according to the principles of "tactical abbreviated surgical care" (TASC). This means that in extreme cases the initial measures have to be concerted to save as much lives as possible while accepting a reduced individual outcome.
Subject(s)
Disaster Planning , Mass Casualty Incidents , Terrorism , Emergency Service, Hospital , Hospitals , Humans , TriageABSTRACT
BACKGROUND: Patient-centeredness has developed into the guiding principle of healthcare policy over the last decade. However, its practical implementation is hindered by numerous problems and opposing interests. OBJECTIVE: To define and elucidate the term patient-centeredness, describe evidence-based measurement tools and outline recommendations for practical implementation. MATERIAL AND METHODS: A narrative literature review was carried out in Medline, Cochrane Library, PsyINfo and CINHAL. Based on the results the concept of Patient-Reported Experience Measures (PREM) is explained and a comprehensive PREM system is developed. RESULTS: Patient-centeredness is a not yet clearly defined theoretical construct. Patient-centeredness covers up to 16 different aspects ranging from patient involvement to the transition of care. Patient centeredness is most frequently measured via PREMs. Contrary to other countries, there are only a limited number of validated PREMs available in German and measurement qualities are frequently unclear or insufficient. No comprehensive PREM system has been developed for the German language so far. Important aspects of surgical care are not captured by currently available German language PREMs. CONCLUSION: Contrary to other countries no comprehensive PREM system is available in the German language. Currently available German PREMs do not enable the adequate assessment of surgical aspects of care. Important organizational, regulatory, methodological, and financial aspects must be addressed before patient-centeredness can be implemented into every clinical practice in German-speaking countries.
Subject(s)
Patient Participation , Humans , Surveys and QuestionnairesABSTRACT
In its most trending interpretation, empowerment in health care is implemented as a patient-centered approach. In the same sense, many mobile health (mHealth) apps are being developed with a primary focus on the individual user. The integration of mHealth apps into the health care system has the potential to counteract existing challenges, including incomplete or nonstandardized medical data and lack of communication, especially in the intersectional context (eg, patients, medical forces). However, concerns about data security and privacy, regional differences in regulations, lack of accessibility, and nontransparent apps hinder the successful integration of mHealth into the health care system. One approach to address this is to rethink the interpretation of empowerment. On that basis, we here examine existing approaches of individual empowerment and subsequently analyze a different view of empowerment in digital health, namely interaction empowerment. Such a change of perspective could positively influence intersectoral communication and facilitate secure data and knowledge sharing. We discuss this novel viewpoint on empowerment, focusing on more efficient integration and development of mHealth approaches. A renewed interpretation of empowerment could thus buffer current limitations of individual empowerment while also advancing digitization of the health system.
Subject(s)
Mobile Applications , Telemedicine , Computer Security , Delivery of Health Care , Humans , PrivacyABSTRACT
[This corrects the article DOI: 10.2196/27348.].
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BACKGROUND: Overcoming the COVID-19 crisis requires new ideas and strategies for online communication of personal medical information and patient empowerment. Rapid testing of a large number of subjects is essential for monitoring and delaying the spread of SARS-CoV-2 in order to mitigate the pandemic's consequences. People who do not know that they are infected may not stay in quarantine and, thus, risk infecting others. Unfortunately, the massive number of COVID-19 tests performed is challenging for both laboratories and the units that conduct throat swabs and communicate the results. OBJECTIVE: The goal of this study was to reduce the communication burden for health care professionals. We developed a secure and easy-to-use tracking system to report COVID-19 test results online that is simple to understand for the tested subjects as soon as these results become available. Instead of personal calls, the system updates the status and the results of the tests automatically. This aims to reduce the delay when informing testees about their results and, consequently, to slow down the virus spread. METHODS: The application in this study draws on an existing tracking tool. With this open-source and browser-based online tracking system, we aim to minimize the time required to inform the tested person and the testing units (eg, hospitals or the public health care system). The system can be integrated into the clinical workflow with very modest effort and avoids excessive load to telephone hotlines. RESULTS: The test statuses and results are published on a secured webpage, enabling regular status checks by patients; status checks are performed without the use of smartphones, which has some importance, as smartphone usage diminishes with age. Stress tests and statistics show the performance of our software. CTest is currently running at two university hospitals in Germany-University Hospital Ulm and University Hospital Tübingen-with thousands of tests being performed each week. Results show a mean number of 10 (SD 2.8) views per testee. CONCLUSIONS: CTest runs independently of existing infrastructures, aims at straightforward integration, and aims for the safe transmission of information. The system is easy to use for testees. QR (Quick Response) code links allow for quick access to the test results. The mean number of views per entry indicates a reduced amount of time for both health care professionals and testees. The system is quite generic and can be extended and adapted to other communication tasks.
Subject(s)
COVID-19/diagnosis , COVID-19/psychology , Communication , Medical Informatics/organization & administration , Medical Informatics/standards , Pandemics , Patient Participation , SARS-CoV-2/isolation & purification , COVID-19/epidemiology , COVID-19/virology , Germany , Humans , Time FactorsABSTRACT
The COVID-19 pandemic has caused strains on health systems worldwide disrupting routine hospital services for all non-COVID patients. Within this retrospective study, we analyzed inpatient hospital admissions across 18 German university hospitals during the 2020 lockdown period compared to 2018. Patients admitted to hospital between January 1 and May 31, 2020 and the corresponding periods in 2018 and 2019 were included in this study. Data derived from electronic health records were collected and analyzed using the data integration center infrastructure implemented in the university hospitals that are part of the four consortia funded by the German Medical Informatics Initiative. Admissions were grouped and counted by ICD 10 chapters and specific reasons for treatment at each site. Pooled aggregated data were centrally analyzed with descriptive statistics to compare absolute and relative differences between time periods of different years. The results illustrate how care process adoptions depended on the COVID-19 epidemiological situation and the criticality of the disease. Overall inpatient hospital admissions decreased by 35% in weeks 1 to 4 and by 30.3% in weeks 5 to 8 after the lockdown announcement compared to 2018. Even hospital admissions for critical care conditions such as malignant cancer treatments were reduced. We also noted a high reduction of emergency admissions such as myocardial infarction (38.7%), whereas the reduction in stroke admissions was smaller (19.6%). In contrast, we observed a considerable reduction in admissions for non-critical clinical situations, such as hysterectomies for benign tumors (78.8%) and hip replacements due to arthrosis (82.4%). In summary, our study shows that the university hospital admission rates in Germany were substantially reduced following the national COVID-19 lockdown. These included critical care or emergency conditions in which deferral is expected to impair clinical outcomes. Future studies are needed to delineate how appropriate medical care of critically ill patients can be maintained during a pandemic.
Subject(s)
COVID-19/epidemiology , Emergency Service, Hospital/statistics & numerical data , Hospitalization/statistics & numerical data , Hospitals, University/statistics & numerical data , Pandemics/statistics & numerical data , Patient Admission/statistics & numerical data , Quarantine/statistics & numerical data , Emergency Service, Hospital/trends , Forecasting , Germany/epidemiology , Hospitalization/trends , Hospitals, University/trends , Humans , Patient Admission/trends , Quarantine/trends , Retrospective Studies , SARS-CoV-2ABSTRACT
For patients with acute respiratory insufficiency, mechanical ("invasive") ventilation is a fundamental therapeutic measure to ensure sufficient gas exchange. Despite decades of strong research efforts, central questions on mechanical ventilation therapy are still answered incompletely. Therefore, many different ventilation modes and settings have been used in daily clinical practice without scientifically sound bases. At the same time, implementation of the few evidence-based therapeutic concepts (e.g., "lung protective ventilation") into clinical practice is still insufficient. The aim of our guideline project "Mechanical ventilation and extracorporeal gas exchange in acute respiratory insufficiency" was to develop an evidence-based decision aid for treating patients with and on mechanical ventilation. It covers the whole pathway of invasively ventilated patients (including indications of mechanical ventilation, ventilator settings, additional and rescue therapies, and liberation from mechanical ventilation). To assess the quality of scientific evidence and subsequently derive recommendations, we applied the Grading of Recommendations, Assessment, Development and Evaluation method. For the first time, using this globally accepted methodological standard, our guideline contains recommendations on mechanical ventilation therapy not only for acute respiratory distress syndrome patients but also for all types of acute respiratory insufficiency. This review presents the two main chapters of the guideline on choosing the mode of mechanical ventilation and setting its parameters. The guideline group aimed that - by thorough implementation of the recommendations - critical care teams may further improve the quality of care for patients suffering from acute respiratory insufficiency. By identifying relevant gaps of scientific evidence, the guideline group intended to support the development of important research projects.
Subject(s)
Extracorporeal Membrane Oxygenation , Respiration, Artificial/methods , Respiratory Distress Syndrome/therapy , Respiratory Insufficiency/therapy , HumansABSTRACT
For patients with acute respiratory insufficiency, mechanical ("invasive") ventilation is a fundamental therapeutic measure to ensure sufficient gas exchange. Despite decades of strong research efforts, central questions on mechanical ventilation therapy are still answered incompletely. Therefore, many different ventilation modes and settings have been used in daily clinical practice without scientifically sound bases. At the same time, implementation of the few evidence-based therapeutic concepts (e.g., "lung protective ventilation") into clinical practice is still insufficient. The aim of our guideline project "Mechanical ventilation and extracorporeal gas exchange in acute respiratory insufficiency" was to develop an evidence-based decision aid for treating patients with and on mechanical ventilation. It covers the whole pathway of invasively ventilated patients (including indications of mechanical ventilation, ventilator settings, additional and rescue therapies, and liberation from mechanical ventilation). To assess the quality of scientific evidence and subsequently derive recommendations, we applied the Grading of Recommendations, Assessment, Development and Evaluation method. For the first time, using this globally accepted methodological standard, our guideline contains recommendations on mechanical ventilation therapy not only for acute respiratory distress syndrome patients but also for all types of acute respiratory insufficiency. This review presents the two main chapters of the guideline on choosing the mode of mechanical ventilation and setting its parameters. The guideline group aimed that - by thorough implementation of the recommendations - critical care teams may further improve the quality of care for patients suffering from acute respiratory insufficiency. By identifying relevant gaps of scientific evidence, the guideline group intended to support the development of important research projects.
Subject(s)
Respiration, Artificial , Respiratory Insufficiency/therapy , Respiratory Distress Syndrome, NewbornABSTRACT
Mechanical ventilation is life-saving for patients with acute respiratory insufficiency. In a German prevalence study, 13.6% of patients in intensive care units received mechanical ventilation for more than 12 hours; 20% of these patients received mechanical ventilation as treatment for acute respiratory distress syndrome (ARDS). The new S3 guideline is the first to contain recommendations for the entire process of treatment in these groups of patients (indications, ventilation modes/parameters, accompanying measures, treatments for refractory impairment of gas exchange, weaning, and follow-up care). This guideline was developed according to the GRADE methods. Pertinent publications were identified by a systematic search of the literature, the quality of the evidence was evaluated, a risk/benefit assessment was conducted, and recommendations were issued by interdisciplinary consensus. Mechanical ventilation is recommended as primary treatment for patients with severe ARDS. In other patient groups, non-invasive ventilation can lower mortality. If mechanical ventilation is needed, ventilation modes allowing spontaneous breathing seem beneficial (quality of evidence [QoE]: very low). Protective ventilation (high positive end-expiratory pressure, low tidal volume, limited peak pressure) improve the survival of ARDS patients (QoE: high). If a severe impairment of gas exchange is present, prone positioning lessens mortality (QoE: high). Veno-venous extracorporeal membrane oxygenation (vvECMO) has not unequivocally been shown to improve survival. Early mobilization and weaning protocols can shorten the duration of ventilation (QoE: moderate). Recommendations for patients undergoing mechanical ventilation include lung-protective ventilation, early spontaneous breathing and mobilization, weaning protocols, and, for those with severe impairment of gas exchange, prone positioning. It is further recommended that patients with ARDS and refractory impairment of gas exchange should be transferred to an ARDS/ECMO center, where extracorporeal methods should be applied only after application of all other therapeutic options.
Subject(s)
Humans , Respiration, Artificial/nursing , Respiration, Artificial/instrumentation , Respiration, Artificial/methods , Respiratory Insufficiency/nursing , Respiratory Insufficiency/prevention & control , Extracorporeal Membrane Oxygenation/nursing , Extracorporeal Membrane Oxygenation/instrumentation , Extracorporeal Membrane Oxygenation/methods , Ventilator Weaning/nursing , Ventilator Weaning/instrumentation , Intensive Care Units/organization & administrationABSTRACT
BACKGROUND: From July 2010-April 2013, Leipzig University Hospital experienced the largest outbreak of a Klebsiella pneumoniae carbapenemase 2 (KPC-2)-producing Klebsiella pneumoniae (KPC-2-Kp) strain observed in Germany to date. After termination of the outbreak, we aimed to reconstruct transmission pathways by phylogenetics based on whole-genome sequencing (WGS). METHODS: One hundred seventeen KPC-2-Kp isolates from 89 outbreak patients, 5 environmental KPC-2-Kp isolates, and 24 K pneumoniae strains not linked to the outbreak underwent WGS. Phylogenetic analysis was performed blinded to clinical data and based on the genomic reads. RESULTS: A patient from Greece was confirmed as the source of the outbreak. Transmission pathways for 11 out of 89 patients (12.4%) were plausibly explained by descriptive epidemiology, applying strict definitions. Five of these and an additional 15 (ie, 20 out of 89 patients [22.5%]) were confirmed by phylogenetics. The rate of phylogenetically confirmed transmissions increased significantly from 8 out of 66 (12.1% for the time period before) to 12 out of 23 patients (52.2% for the time period after; P <.001) after implementation of systematic screening for KPC-2-Kp (33,623 screening investigations within 11 months). Using descriptive epidemiology, systematic screening showed no significant effect (7 out of 66 [10.6%] vs 4 out of 23 [17.4%] patients; P = .465). The phylogenetic analysis supported the assumption that a contaminated positioning pillow served as a reservoir for the persistence of KPC-2-Kp. CONCLUSIONS: Effective phylogenetic identification of transmissions requires systematic microbiologic screening. Extensive screening and phylogenetic analysis based on WGS should be started as soon as possible in a bacterial outbreak situation.
Subject(s)
Carbapenems/pharmacology , Drug Resistance, Multiple, Bacterial/genetics , Genome, Bacterial , Klebsiella Infections/microbiology , Klebsiella pneumoniae/drug effects , Phylogeny , Disease Outbreaks , Germany/epidemiology , Hospitals , Humans , Klebsiella Infections/epidemiology , Klebsiella Infections/mortality , Klebsiella pneumoniae/genetics , Molecular Epidemiology , Retrospective StudiesABSTRACT
BACKGROUND: Mechanical ventilation is life-saving for patients with acute respiratory insufficiency. In a German prevalence study, 13.6% of patients in intensive care units received mechanical ventilation for more than 12 hours; 20% of these patients received mechanical ventilation as treatment for acute respiratory distress syndrome (ARDS). The new S3 guideline is the first to contain recommendations for the entire process of treatment in these groups of patients (indications, ventilation modes/parameters, ac- companying measures, treatments for refractory impairment of gas exchange, weaning, and follow-up care). METHODS: This guideline was developed according to the GRADE methods. Pertinent publications were identified by a systematic search of the literature, the quality of the evidence was evaluated, a risk/benefit assessment was conducted, and recommendations were issued by interdisciplinary consensus. RESULTS: Mechanical ventilation is recommended as primary treatment for patients with severe ARDS. In other patient groups, non-in- vasive ventilation can lower mortality. If mechanical ventilation is needed, ventilation modes allowing spontaneous breathing seem beneficial (quality of evidence [QoE]: very low). Protective ventilation (high positive end-expiratory pressure, low tidal volume, limited peak pressure) improve the survival of ARDS patients (QoE: high). If a severe impairment of gas exchange is present, prone posi- tioning lessens mortality (QoE: high). Veno-venous extracorporeal membrane oxygenation (vvECMO) has not unequivocally been shown to improve survival. Early mobilization and weaning protocols can shorten the duration of ventilation (QoE: moderate). CONCLUSION: Recommendations for patients undergoing mechanical ventilation include lung-protective ventilation, early sponta- neous breathing and mobilization, weaning protocols, and, for those with severe impairment of gas exchange, prone positioning. It is further recommended that patients with ARDS and refractory impairment of gas exchange should be transferred to an ARDS/ECMO center, where extracorporeal methods should be applied only after application of all other therapeutic options.
Subject(s)
Extracorporeal Membrane Oxygenation/instrumentation , Respiration, Artificial/adverse effects , Respiratory Distress Syndrome/therapy , Respiratory Insufficiency/diagnosis , Acute Disease , Early Ambulation/standards , Germany/epidemiology , Humans , Intensive Care Units/statistics & numerical data , Meta-Analysis as Topic , Oxygen Consumption , Positive-Pressure Respiration/instrumentation , Prone Position/physiology , Pulmonary Gas Exchange/physiology , Randomized Controlled Trials as Topic , Respiratory Distress Syndrome/diagnosis , Respiratory Distress Syndrome/epidemiology , Respiratory Distress Syndrome/mortality , Respiratory Insufficiency/blood , Respiratory Insufficiency/physiopathology , Tidal Volume , Ventilator Weaning/methods , Ventilator Weaning/standardsABSTRACT
PURPOSE: Guidelines recommend administering antibiotics within 1 h of sepsis recognition but this recommendation remains untested by randomized trials. This trial was set up to investigate whether survival is improved by reducing the time before initiation of antimicrobial therapy by means of a multifaceted intervention in compliance with guideline recommendations. METHODS: The MEDUSA study, a prospective multicenter cluster-randomized trial, was conducted from July 2011 to July 2013 in 40 German hospitals. Hospitals were randomly allocated to receive conventional continuous medical education (CME) measures (control group) or multifaceted interventions including local quality improvement teams, educational outreach, audit, feedback, and reminders. We included 4183 patients with severe sepsis or septic shock in an intention-to-treat analysis comparing the multifaceted intervention (n = 2596) with conventional CME (n = 1587). The primary outcome was 28-day mortality. RESULTS: The 28-day mortality was 35.1% (883 of 2596 patients) in the intervention group and 26.7% (403 of 1587 patients; p = 0.01) in the control group. The intervention was not a risk factor for mortality, since this difference was present from the beginning of the study and remained unaffected by the intervention. Median time to antimicrobial therapy was 1.5 h (interquartile range 0.1-4.9 h) in the intervention group and 2.0 h (0.4-5.9 h; p = 0.41) in the control group. The risk of death increased by 2% per hour delay of antimicrobial therapy and 1% per hour delay of source control, independent of group assignment. CONCLUSIONS: Delay in antimicrobial therapy and source control was associated with increased mortality but the multifaceted approach was unable to change time to antimicrobial therapy in this setting and did not affect survival.
Subject(s)
Anti-Bacterial Agents/therapeutic use , Guideline Adherence , Quality Improvement , Shock, Septic/drug therapy , Time-to-Treatment , Aged , Education, Continuing , Female , Hospital Mortality , Humans , Intensive Care Units/statistics & numerical data , Intention to Treat Analysis , Length of Stay/statistics & numerical data , Male , Middle Aged , Prospective Studies , Risk Factors , Shock, Septic/mortalityABSTRACT
BACKGROUND: The laryngeal tube suction II (LTS II) is a supraglottic airway device (SAD) with a gastric drainage tube and enhanced seal properties as compared with other SADs. Therefore, its use has been proposed in situations with an elevated risk of aspiration. OBJECTIVES: To compare the safety and efficacy of airway management and controlled mechanical ventilation when using either an LTS II or an endotracheal tube for laparoscopic radical prostatectomy. DESIGN: Randomised, controlled, blinded and single-centre study. SETTING: Academic tertiary care centre in Leipzig from April 2014 to May 2015. PATIENTS: It was planned to include 100 patients but the study was stopped after 50 patients following an interim analysis. These 50 patients were randomised to either the LTS II group or the endotracheal tube group. All male patients aged more than 18 years for elective laparoscopic radical prostatectomy were eligible. Exclusion criteria included a BMI more than 30, American Society of Anesthesiologists class III or greater, a history of gastroesophageal reflux or other factors known to increase the risk of aspiration and a known difficult airway. INTERVENTIONS: All patients received general anaesthesia. Airway management was with either a LTS II or an endotracheal tube, according to the randomisation. MAIN OUTCOME MEASURES: The primary endpoint was successful insertion of the particular airway device during anaesthesia for laparoscopic radical prostatectomy. RESULTS: In 15 of the 28 patients randomised to LTS II, the device had to be removed and an endotracheal tube inserted, mainly because of an airway leak (nâ=â10) or swelling of the tongue (nâ=â3). Ventilation was successful in all patients (nâ=â22) randomised to endotracheal tube. Quality of ventilation was rated better in the endotracheal tube group. CONCLUSION: Our data suggest that LTS II should not be the preferred method of airway management in patients undergoing laparoscopic radical prostatectomy. TRIAL REGISTRATION: DRKS00008985 (German Clinical Trials Register).
Subject(s)
Head-Down Tilt , Intubation, Intratracheal/methods , Laparoscopy/methods , Laryngeal Masks , Patient Positioning/methods , Prostatectomy/methods , Airway Management/methods , Double-Blind Method , Humans , Male , Suction/methodsABSTRACT
Pulmonary arterial hypertension is a life-threatening disease with a poor prognosis. Oral treatment with vasodilators is often limited by systemic hypotension. Inhalation of vasodilators offers the opportunity for selective pulmonary vasodilation. Testing selective pulmonary vasodilation by inhaled nitric oxide or alternative substances in animal models requires an increased pulmonary vascular tone. The aim of this study was to identify animal models that are suitable for investigating selective pulmonary vasodilation. To do so, a haemodynamic stable pulmonary hypertension was initiated, with a 30 min duration deemed to be a sufficient time interval before and after a possible intervention. In anaesthetized and mechanically-ventilated Sprague-Dawley rats pulmonary hypertension was induced either by acute hypoxia due to reduction of the inspired oxygen fraction from 0.21 to 0.1 ( n = 6), a fixed infusion rate of the thromboxane analogue U46619 (240 ng/min; n = 6) or a monocrotaline injection (MCT; 60 mg/kg applied 23 days before the investigation; n = 7). The animals were instrumented to measure right ventricular and systemic arterial pressures. Acute hypoxia caused a short, and only transient, increase of pulmonary artery pressure as well as profound systemic hypotension which suggested haemodynamic instability. U46619 infusion induced variable changes in the pulmonary and systemic vascular tone without sufficient stabilization within 30 min. MCT provoked sustained pulmonary hypertension with normal systemic pressure values and inhalation of nitric oxide caused selective pulmonary vasodilation. In conclusion, out of the three examined rat animal models only MCT-induced pulmonary hypertension is a solid and reliable model for investigating selective pulmonary vasodilation.
Subject(s)
Disease Models, Animal , Hypertension, Pulmonary/drug therapy , Vasodilator Agents/administration & dosage , Administration, Inhalation , Animals , Lung , Rats , Rats, Sprague-Dawley , VasodilationABSTRACT
IMPORTANCE: High-dose intravenous administration of sodium selenite has been proposed to improve outcome in sepsis by attenuating oxidative stress. Procalcitonin-guided antimicrobial therapy may hasten the diagnosis of sepsis, but effect on outcome is unclear. OBJECTIVE: To determine whether high-dose intravenous sodium selenite treatment and procalcitonin-guided anti-infectious therapy in patients with severe sepsis affect mortality. DESIGN, SETTING, AND PARTICIPANTS: The Placebo-Controlled Trial of Sodium Selenite and Procalcitonin Guided Antimicrobial Therapy in Severe Sepsis (SISPCT), a multicenter, randomized, clinical, 2 × 2 factorial trial performed in 33 intensive care units in Germany, was conducted from November 6, 2009, to June 6, 2013, including a 90-day follow-up period. INTERVENTIONS: Patients were randomly assigned to receive an initial intravenous loading dose of sodium selenite, 1000 µg, followed by a continuous intravenous infusion of sodium selenite, 1000 µg, daily until discharge from the intensive care unit, but not longer than 21 days, or placebo. Patients also were randomized to receive anti-infectious therapy guided by a procalcitonin algorithm or without procalcitonin guidance. MAIN OUTCOMES AND MEASURES: The primary end point was 28-day mortality. Secondary outcomes included 90-day all-cause mortality, intervention-free days, antimicrobial costs, antimicrobial-free days, and secondary infections. RESULTS: Of 8174 eligible patients, 1089 patients (13.3%) with severe sepsis or septic shock were included in an intention-to-treat analysis comparing sodium selenite (543 patients [49.9%]) with placebo (546 [50.1%]) and procalcitonin guidance (552 [50.7%]) vs no procalcitonin guidance (537 [49.3%]). The 28-day mortality rate was 28.3% (95% CI, 24.5%-32.3%) in the sodium selenite group and 25.5% (95% CI, 21.8%-29.4%) (P = .30) in the placebo group. There was no significant difference in 28-day mortality between patients assigned to procalcitonin guidance (25.6% [95% CI, 22.0%-29.5%]) vs no procalcitonin guidance (28.2% [95% CI, 24.4%-32.2%]) (P = .34). Procalcitonin guidance did not affect frequency of diagnostic or therapeutic procedures but did result in a 4.5% reduction of antimicrobial exposure. CONCLUSIONS AND RELEVANCE: Neither high-dose intravenous administration of sodium selenite nor anti-infectious therapy guided by a procalcitonin algorithm was associated with an improved outcome in patients with severe sepsis. These findings do not support administration of high-dose sodium selenite in these patients; the application of a procalcitonin-guided algorithm needs further evaluation. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00832039.
Subject(s)
Anti-Bacterial Agents/administration & dosage , Antioxidants/therapeutic use , Calcitonin/blood , Sepsis/drug therapy , Shock, Septic/drug therapy , Sodium Selenite/therapeutic use , Aged , Algorithms , Biomarkers/blood , Dose-Response Relationship, Drug , Drug Administration Schedule , Drug Monitoring/methods , Female , Germany/epidemiology , Hospital Mortality , Humans , Infusions, Intravenous , Intensive Care Units , Male , Middle Aged , Sepsis/mortality , Severity of Illness Index , Shock, Septic/mortalityABSTRACT
AIM: To analyze differences in patients' clinical course, we compared two regimes of either preemptive therapy or prophylaxis after liver transplantation. METHODS: This retrospective study was reviewed and approved by the institutional review board of the University of Leipzig. Cytomegalovirus (CMV) prophylaxis with valganciclovir hydrochloride for liver transplant recipients was replaced by a preemptive strategy in October 2009. We retrospectively compared liver transplant recipients 2 years before and after October 2009. During the first period, all patients received valganciclovir daily. During the second period all patients included in the analysis were treated following a preemptive strategy. Outcomes included one year survival and therapeutic intervention due to CMV viremia or infection. RESULTS: Between 2007 and 2010 n = 226 patients underwent liver transplantation in our center. n = 55 patients were D(+)/R(-) high risk recipients and were excluded from further analysis. A further 43 patients had to be excluded since CMV prophylaxis/preemptive strategy was not followed although there was no clinical reason for the deviation. Of the remaining 128 patients whose data were analyzed, 60 received prophylaxis and 68 were treated following a preemptive strategy. The difference in overall mortality was not significant, nor was it significant for one-year mortality where it was 10% (95%CI: 8%-28%, P = 0.31) higher for the preemptive group. No significant differences in blood count abnormalities or the incidence of sepsis and infections were observed other than CMV. In total, 19 patients (14.7%) received ganciclovir due to CMV viremia and/or infections. Patients who were treated according to the preemptive algorithm had a significantly higher rate risk of therapeutic intervention with ganciclovir [n = 16 (23.5%) vs n = 3 (4.9%), P = 0.003)]. CONCLUSION: These data suggest that CMV prophylaxis is superior to a preemptive strategy in patients undergoing liver transplantation.