The PROMISE study protocol: a multicenter prospective study of process optimization with interdisciplinary and cross-sectoral care for German patients receiving hip and knee endoprostheses.

Background and purpose - Knee and hip replacement are common and increasing procedures, and an optimized care process that could be implemented in different settings would be useful. The PROMISE trial investigates whether a new care process works equally in different German settings and how the results compare with current non-standardized care.Patients and methods - This multi-center prospective mixed-method study includes 2,000 German patients receiving arthritis-related hip or knee endoprostheses. An interdisciplinary and cross-sectoral care process was developed and implemented in 3 German hospitals with different levels of care, and corresponding rehabilitation centers were included to bridge the gap after acute care.Duration and outcome - The PROMISE trial recruited patients between May 2018 and March 2020. Follow-up will end in February 2021. Assessments are performed at: examination on clinical indication, 1 week before surgery, on the day of surgery, at the end of hospitalization, end of the rehabilitation program, and 3 months, 6 months, and 12 months after surgery. Outcomes include patient-reported outcomes, medical examination findings, and routinely collected data regarding the surgery and complications. Guideline-based interviews are conducted with selected patients and care partners. The primary endpoint is the presence of chronic pain at 12 months after surgery. Secondary endpoints are the number of recognized pre-existing conditions, physical activity at 12 months after surgery, use of medical services, quality of life, and interactions between care partners.Trial registration - The trial is registered with the German Clinical Trials Register (https://www.drks.de; DRKS00013972; March 23, 2018).

Endexpiratory lung volume measurement correlates with the ventilation/perfusion mismatch in lung injured pigs.

BACKGROUND: In acute respiratory respiratory distress syndrome (ARDS) a sustained mismatch of alveolar ventilation and perfusion (VA/Q) impairs the pulmonary gas exchange. Measurement of endexpiratory lung volume (EELV) by multiple breath-nitrogen washout/washin is a non-invasive, bedside technology to assess pulmonary function in mechanically ventilated patients. The present study examines the association between EELV changes and VA/Q distribution and the possibility to predict VA/Q normalization by means of EELV in a porcine model. METHODS: After approval of the state and institutional animal care committee 12 anesthetized pigs were randomized to ARDS either by bronchoalveolar lavage (n = 6) or oleic acid injection (n = 6). EELV, VA/Q ratios by multiple inert gas elimination and ventilation distribution by electrical impedance tomography were assessed at healthy state and at five different positive endexpiratory pressure (PEEP) steps in ARDS (0, 20, 15, 10, 5 cmH2O; each maintained for 30 min). RESULTS: VA/Q, EELV and tidal volume distribution all displayed the PEEP-induced recruitment in ARDS. We found a close correlation between VA/Q < 0.1 (representing shunt and low VA/Q units) and changes in EELV (spearman correlation coefficient -0.79). Logistic regression reveals the potential to predict VA/Q normalization (VA/Q < 0.1 less than 5%) from changes in EELV with an area under the curve of 0.89 with a 95%-CI of 0.81-0.96 in the receiver operating characteristic. Different lung injury models and recruitment characteristics did not influence these findings. CONCLUSION: In a porcine ARDS model EELV measurement depicts PEEP-induced lung recruitment and is strongly associated with normalization of the VA/Q distribution in a model-independent fashion. Determination of EELV could be an intriguing addition in the context of lung protection strategies.

Transanal total mesorectal excision for restorative coloproctectomy in an obese high-risk patient with colitis-associated carcinoma.

Transanal total mesorectal excision (TaTME) offers great potential for the treatment of malign and benign diseases. However, laparoscopic-assisted TaTME in ulcerative colitis has not been described in more than a handful of patients. We present a 47-year-old highly comorbid female patient with an ulcerative colitis-associated carcinoma of the ascending colon and steroid- refractory pancolitis. A two-stage restorative coloproctectomy including right-sided complete mesocolic excision was conducted. The second step consisted of a successful nerve-sparing TaTME and a handsewn ileal pouch-anal anastomosis. TaTME may extend the possible treatment options in inflammatory bowel disease, especially for high-risk patients.

Risk and Complication Management in Esophageal Cancer Surgery: A Review of the Literature.

Esophagectomy for cancer is a highly complex and demanding two-cavity procedure associated with a considerable morbidity and mortality. There are several controversies with regard to the optimal risk and complication management. Strategies include patient selection, optimization of malnutrition, hospital and surgeon volume, intraoperative anesthesiological and surgical measures, and postoperative management of complications. In this article, we review the literature on these aspects that have an impact on outcomes after esophagectomy.

Lay basic life support: the current situation in a medium-sized German town.

OBJECTIVE: Basic life support (BLS) by laypersons is essential for surviving sudden cardiac death in the community. The present study investigates BLS skill knowledge of German laypersons in a public community place and examines the effect of the interval between the last BLS course and present skills in cardiopulmonary resuscitation (CPR). METHODS: Participants were randomly recruited at a public place in a medium-sized German town. Volunteers were confronted with a fictitious cardiac arrest situation using a BLS training manikin and were asked to help. Using a standardised evaluation sheet, measures were documented. Participants' demographic data were evaluated after completion of the scenario. RESULTS: None of the participants (n=89; male=42, female=47) followed the current BLS algorithm correctly; independent from the last CPR course was attended. Most steps were performed in random order. 43% (n=38) of participants checked for responsiveness, 65% (n=58) performed chest compressions, and 63% (n=56) delivered rescue breathing. 10% (n=9) of participants were unable to name a national emergency telephone number. Laypersons who attended a BLS course more than 10 years ago showed a significant lack of BLS knowledge and failed more often to deliver chest compressions and rescue breathing. CONCLUSIONS: The present study demonstrates that current CPR guidelines for BLS are not followed by laypersons in a medium-sized town in Germany. These data suggest that CPR refresher courses as well as implication of BLS guidelines in daily life are warranted.

Anaesthesia protocol evaluation of the videolaryngoscopy with the McGrath MAC and direct laryngoscopy for tracheal intubation in 1000 patients undergoing rapid sequence induction: the randomised multicentre LARA trial study protocol.

INTRODUCTION: Rapid sequence induction of anaesthesia is indicated in patients with an increased risk of pulmonary aspiration. The main objective of the technique is to reduce the critical time period between loss of airway protective reflexes and rapid inflation of the cuff of the endotracheal tube to minimise the chance of aspiration of gastric contents. The COVID-19 pandemic has reinforced the importance of first-pass intubation success to ensure patient and healthcare worker safety. The aim of this study is to compare the first-pass intubation success rate (FPS) using the videolaryngoscopy compared with conventional direct laryngoscopy in surgical patients with a high risk of pulmonary aspiration. METHODS AND ANALYSIS: The LARA trial is a multicentre, patient-blinded, randomised controlled trial. Consecutive patients requiring tracheal intubation are randomly allocated to either the McGrath MAC videolaryngoscope or direct laryngoscopy using the Macintosh laryngoscope. The expected rate of FPS is 92% in the McGrath group and 82% in the Macintosh group. Each group must include a total of 500 patients to achieve 90% power for detecting a difference at the 5% significance level. Successful intubation with the FPS is the primary endpoint. The secondary endpoints are the time to intubation, the number of intubation attempts, the necessity of airway management alternatives, the visualisation of the glottis using the Cormack and Lehane Score and the Percentage Of Glottic Opening Score and definite adverse events. ETHICS AND DISSEMINATION: The project is approved by the local ethics committee of the Medical Association of the Rhineland Palatine state (registration number: 2020-15502) and medical ethics committee of the University of Freiburg (registration number: 21-1303). The results of this study will be made available in form of manuscripts for publication and presentations at national and international meetings. TRIAL REGISTRATION: NCT04794764.

The Orogastric Tube Guide® as a novel strategy for gastric tube insertion: a prospective, randomized controlled clinical trial.

BACKGROUND: Gastric tube insertion, either orally or nasally, is daily practice in anesthesia and intensive care. "Blind" insertion represents the common conventional method and is associated with low first-pass success and frequent complications. This trial aimed to evaluate the novel gastric tube guide as a rigid conduit in regard to insertion success rate, time required and associated complications versus the conventional "blind" insertion method. We hypothesized that the insertion success rate is higher using the Orogastric tube guide. METHODS: This trial was approved by ethics committee prior to patient recruitment. In a randomized order, anesthetists performed oral insertion of a gastric tube either with the Orogastric tube guide (GTG) or by conventional "blind" technique (CONV) in elective surgical patients. Exclusion criteria were defined as age under 18 years, pregnancy, emergency surgery and patients without indication for tracheal intubation and gastric tube insertion. RESULTS: We examined 151 patients (GTG, N.=71; CONV, N.=80). The success rate was higher with the GTG compared to the conventional method (69/71 (97%) vs. 61/80 (76%); P<0.001). The median insertion time was 25 s (IQR 20-39) using the GTG and 31 s (IQR 24-58; P=0.027) with the conventional method. We found no differences with regard to complications between the groups (P=0.54). CONCLUSIONS: Our findings suggest that the use of the GTG facilitates and fastens orogastric tube placement in anesthetized patients and thereby constitutes a benefit in clinical routine.

[A German network for regional anaesthesia of the scientific working group regional anaesthesia within DGAI and BDA]. / Das Netzwerk Regionalanästhesie des wissenschaftlichen Arbeitskreises Regionalanästhesie der DGAI und des BDA.

Regional anaesthesia generally is considered to be safe. However, reports of complications with different severities are also well known. The scientific working group of regional anaesthesia of the DGAI has founded a network in conjunction with the BDA. With the aid of a registry, we are now able to describe risk profiles and associations in case of a complication. Moreover, a benchmark has been implemented in order to continuously improve complication rates.

Random allogeneic blood transfusion in pigs: characterisation of a novel experimental model.

BACKGROUND: Organ cross-talk describes interactions between a primary affected organ and a secondarily injured remote organ, particularly in lung-brain interactions. A common theory is the systemic distribution of inflammatory mediators that are released by the affected organ and transferred through the bloodstream. The present study characterises the baseline immunogenic effects of a novel experimental model of random allogeneic blood transfusion in pigs designed to analyse the role of the bloodstream in organ cross-talk. METHODS: After approval of the State and Institutional Animal Care Committee, 20 anesthetized pig were randomized in a donor and an acceptor (each n = 8): the acceptor animals each received high-volume whole blood transfusion from the donor (35-40 ml kg-1). Four animals received balanced electrolyte solution instead of blood transfusion (control group; n = 4). Afterwards the animals underwent extended cardiorespiratory monitoring for eight hours. Post mortem assessment included pulmonary, cerebral and systemic mediators of early inflammatory response (IL-6, TNF-alpha, iNOS), wet to dry ratio, and lung histology. RESULTS: No adverse events or incompatibilities occurred during the blood transfusion procedures. Systemic cytokine levels and pulmonary function were unaffected. Lung histopathology scoring did not display relevant intergroup differences. Neither within the lung nor within the brain an up-regulation of inflammatory mediators was detected. High volume random allogeneic blood transfusion in pigs neither impaired pulmonary integrity nor induced systemic, lung, or brain inflammatory response. CONCLUSION: This approach can represent a novel experimental model to characterize the blood-bound transmission in remote organ injury.

A case control study of statin and magnesium administration in patients after aneurysmal subarachnoid hemorrhage: incidence of delayed cerebral ischemia and mortality.

OBJECTIVE: To analyse the effect of the implementation of statin and magnesium treatment on delayed cerebral ischemia (DCI) and 14 day mortality in patients with subarachnoid hemorrhage (SAH). METHODS: Retrospective, single-center, observational case control study. One hundred SAH patients received either simvastatin and magnesium, solely statin or no treatment. RESULTS: Eighteen percent (n=5) of patients receiving statin and magnesium treatment developed a DCI whereas 24% (n=5) in the statin group and 16% (n=8) in the control group had DCI. Dead by day 14 was registered in 18% (n=5) of patients in the statin and magnesium group, in 10% (n=2) in the statin group and in 27% (n=14) in the control group. None of the results reached a statistical significance level of 0.05. CONCLUSION: A trend towards a lower mortality within 14 days in patients receiving solely simvastatin and those receiving statin and magnesium as compared with the control group was found. A higher incidence for DCI was found in the statin group, whereas patients without statin and magnesium tended to have less often DCI. None of the results was statistically significant.

Postoperative analgesic efficacy of peripheral levobupivacaine and ropivacaine: a prospective, randomized double-blind trial in patients after total knee arthroplasty.

BACKGROUND: Several previous trials have characterized the intra- and postoperative effects of the recently introduced local anesthetics, levobupivacaine and ropivacaine, for a variety of continuous peripheral nerve blocks. METHODS: We compared the analgesic efficacy of levobupivacaine 0.125% versus ropivacaine 0.2% via patient-controlled femoral nerve analgesia after total knee arthroplasty. In a double-blind, randomized, prospective design, 60 patients received femoral infusion with either substance. We analyzed postoperative local anesthetic consumption, pain scores, motor block, and opioid requirements over 72 h. RESULTS: Pain scores, motor block incidence, and opioid requirements were low and not different between the groups. Ropivacaine consumption in milligrams was 67% higher than that of levobupivacaine. CONCLUSIONS: Both levobupivacaine 0.125% and ropivacaine 0.2% provide similar analgesia after total knee arthroplasty with the latter being less potent.

Opioid Rotation in Cancer Pain Treatment.

BACKGROUND: Rotating several different WHO level III opioid drugs is a therapeutic option for patients with chronic cancer-related pain who suffer from inadequate analgesia and/or intolerable side effects. The evidence favoring opioid rotation is controversial, and the current guidelines in Germany and other countries contain only weak recommendations for it. METHODS: This review is based on pertinent publications retrieved by a systematic review of the literature on opioid rotation for adult patients with chronic cancerrelated pain who are regularly taking WHO level III opioids by the oral or trans - dermal route. RESULTS: 9 individual studies involving a total of 725 patients were included in the analysis, and 3 previous systematic reviews of studies involving a total of 2296 patients were also analyzed. Morphine, oxycodone, fentanyl, hydromorphone, and buprenorphine were used as first-line opioid drugs, and hydromorphone, bupre - norphine, tapentadol, fentanyl, morphine, oxymorphone, and methadone were used as second-line opioid drugs. In all of the studies, pain control was achieved for 14 days after each rotation. In most of them, the dose of the new drug introduced in each rotation needed to be increased above the dose initially calculated from a rotation ratio, with the exception of rotations to methadone. The frequency of side effects was only rarely lessened, but patients largely considered the result of opioid rotation to be positive. No particular opioid drug was found to be best. CONCLUSION: Opioid rotation can improve analgesia and patient satisfaction. The success of opioid rotation appears to depend on the magnitude of the initial dose, among other factors. Tables of equianalgesic doses should be considered no more than a rough guide for determining the dose of the new drug. Rotations to methadone should be carried out under clinical supervision in experienced hands.

Influence of different calcium phosphate ceramics on growth and differentiation of cells in osteoblast-endothelial co-cultures.

Strategies for improvement of angiogenesis and vasculogenesis using different cells and materials are paramount aims in the field of bone tissue engineering. Thereby, the interaction between different cell types and scaffold materials is crucial for growth, differentiation, and long-term outcomes of tissue-engineered constructs. In this study, we evaluated the interaction of osteoblasts and endothelial cells in three-dimensional tissue-engineered constructs using beta tricalciumphosphate (ß-TCP, [ß-Ca3 (PO4 )2 ]) and calcium-deficient hydroxyapatite (CDHA, [Ca9 (PO4 )5 (HPO4 )OH]) ceramics as scaffolds. We focused on initial cell organization, cell proliferation, and differential expression of osteoblastic and endothelial markers employing monocultures and co-cultures of endothelial cells of two different origins [human umbilical vein endothelial cells (HUVECs) and outgrowth endothelial cells (OECs)] with primary human osteoblasts (hOBs). Despite different chemical and physical characteristics of CDHA and ß-TCP ceramics, similar patterns in cell growth, differentiation, and gene expression were detected in tissue-engineered constructs consisting of hOB, HUVEC, and HUVEC/hOB-co-cultures. Under dynamic cell culture conditions we found proliferation of these cells with stable endothelial and osteoblastic differentiation patterns. Both material types are highly biocompatible with these cells providing a promising perspective for the future research. In this study, both materials did not support growth and differentiation of OEC. © 2016 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 105B: 1950-1962, 2017.

LMA Supreme™ and Ambu® AuraGain™ in anesthetized adult patients: a prospective observational study.

BACKGROUND: Second-generation laryngeal masks with gastric access are increasingly used in daily practice and expand the indications for laryngeal masks in the OR. Only limited data exist comparing different types of laryngeal masks. We investigated the second-generation laryngeal masks LMA Supreme™ and Ambu® AuraGain™ in a clinical setting. We hypothesized that the two devices would be comparable in terms of success rate and airway complications. METHODS: After approval from the local ethics committee, data were collected in a prospective trial. Endpoints were success rate, time to insertion and airway morbidity. Anesthesiologists used either the Supreme (Teleflex Medical GmbH) or Gain (Ambu GmbH) laryngeal mask. Patients <18 years and those with a possible risk of regurgitation were excluded. RESULTS: Data from 351 adult patients were documented (Supreme N.=177; Gain N.=174). Success rate for first attempt was 80% (Supreme) and 72% (Gain; P=0.08). Overall success rate was 89% and 92%, respectively (P=0.38). Providers with minimal experience were more successful at first attempt using Supreme (95%), compared to Gain (67%; P=0.01). The median insertion time was shorter in Supreme at 18 s [interquartile range (IQR), 14-25 s] compared to 30 s for Gain [18-41s] (P<0.0001). A higher incidence of airway complications was observed after device removal for Gain (P=0.009). CONCLUSIONS: Supreme was superior to Gain in terms of insertion time and airway morbidity. Novices were more successful at first attempt using Supreme. These differences between supraglottic airway devices might be due to the different shapes and materials of the masks.

Microbial contamination of anesthetic syringes in relation to different handling habits.

This single-center study prospectively assessed the microbial contamination of anesthetic syringes handled perioperatively under different conditions. We documented high rates of bacterial contamination, with strong but statistically nonsignificant differences between handling groups. Our results identify skin contact as the main source of contamination, and thus we emphasize the impact of proper hand hygiene.

Comparison of the McGrath® Series 5 and GlideScope® Ranger with the Macintosh laryngoscope by paramedics.

BACKGROUND: Out-of-hospital endotracheal intubation performed by paramedics using the Macintosh blade for direct laryngoscopy is associated with a high incidence of complications. The novel technique of video laryngoscopy has been shown to improve glottic view and intubation success in the operating room. The aim of this study was to compare glottic view, time of intubation and success rate of the McGrath® Series 5 and GlideScope® Ranger video laryngoscopes with the Macintosh laryngoscope by paramedics. METHODS: Thirty paramedics performed six intubations in a randomised order with all three laryngoscopes in an airway simulator with a normal airway. Subsequently, every participant performed one intubation attempt with each device in the same manikin with simulated cervical spine rigidity using a cervical collar. Glottic view, time until visualisation of the glottis and time until first ventilation were evaluated. RESULTS: Time until first ventilation was equivalent after three intubations in the first scenario. In the scenario with decreased cervical motion, the time until first ventilation was longer using the McGrath® compared to the GlideScope® and AMacintosh (p < 0.01). The success rate for endotracheal intubation was similar for all three devices. Glottic view was only improved using the McGrath® device (p < 0.001) compared to using the Macintosh blade. CONCLUSIONS: The learning curve for video laryngoscopy in paramedics was steep in this study. However, these data do not support prehospital use of the McGrath® and GlideScope® devices by paramedics.

Rigid fibrescope Bonfils: use in simulated difficult airway by novices.

BACKGROUND: The Bonfils intubation fibrescope is a promising alternative device for securing the airway. We examined the success rate of intubation and the ease of use in standardized simulated difficult airway scenarios by physicians. We compared the Bonfils to a classical laryngoscope with Macintosh blade. METHODS: 30 physicians untrained in the use of rigid fibrescopes but experienced in airway management performed endotracheal intubation in an airway manikin (SimMan, Laerdal, Kent, UK) with three different airway conditions. We evaluated the success rate using the Bonfils (Karl Storz, Tuttlingen, Germany) or the Macintosh laryngoscope, the time needed for securing the airway, and subjective rating of both techniques. RESULTS: In normal airway all intubations were successful using laryngoscope (100%) vs. 82% using the Bonfils (p < 0.05). In the scenario "tongue oedema" success rate using the Macintosh laryngoscope was 67% and 83% using the Bonfils. In the scenario "decreased cervical range of motion with jaw trismus", success rate using the Macintosh laryngoscope was 84% vs. 76%. In difficult airway scenarios time until airway was secured did not differ between the two devices. Use of Bonfils was rated "easier" in both difficult airway scenarios. CONCLUSION: The Bonfils can be successfully used by physicians unfamiliar with this technique in an airway manikin. The airway could be secured with at least the same success rate as using a Macintosh laryngoscope in difficult airway scenarios. Use of the Bonfils did not delay intubation in the presence of a difficult airway. These results indicate that intensive special training is advised to use the Bonfils effectively in airway management.

Extracorporeal circulation and cardiac arrest in an awake patient: a safe approach for single lung pulmonary artery stenting?

We describe the anesthetic concept and approach in a single lung patient scheduled for pulmonary artery stenting due to recurrence of a pulmonary artery sarcoma after left pneumectomy.