[Telemedical anesthesia consent - Are the patients ready for it? : A comparative requirement analysis before and during the pandemic]. / Telemedizinische Narkoseaufklärung ­ Sind Patienten bereit dafür? : Eine vergleichende Bedarfsanalyse vor und während der Pandemie.

BACKGROUND: Comprehensive anesthesia preparation by means of the anamnesis and physical examination is considered an essential part of the quality criteria for anesthesia. Especially due to the shortage of specialists, there are usually long waiting times in anesthesia outpatient departments and patients must frequently return in cases of missing or pending findings. Telemedicine already offers alternatives in the context of video communication. These alternatives are now particularly prominent due to the currently existing COVID-19 pandemic and the resulting recommendations for digitalization. OBJECTIVES: This comparative cross-sectional study was carried out to show via a patient survey which patient groups are suitable for a telemedical anesthesia preparation and whether the patients are already technically sufficiently equipped. MATERIAL AND METHODS: For this purpose, a total of 2080 patients (1030 before and 1050 during the pandemic) were interviewed using a questionnaire. For matched paired analyses, 630 pairs were formed according to their age and gender. RESULTS: Before and after the pandemic, there was an increase in the percentage of patients already using video communication in their daily lives (30.4% vs. 41.8%). Before the pandemic, 31.7% of patients indicated that they considered this concept of communication to be a practical and appropriate method for an educational conversation and after the pandemic this number increased to 46.6%. For the majority of patients personal contact with a local anesthesiologist was important (80.7% before vs. 67.4% during the pandemic). The number of patients who had the necessary technical equipment for video communication also increased as a result of the COVID-19 pandemic (50.4% vs. 58.2%). DISCUSSION: Almost half of the patients already seem to be open to a telemedical preoperative evaluation. As digitalization progresses, older generations are more likely to recognize the benefits and be able to own and use the necessary technology in the near future. User acceptance should be the central goal of concept development. This must be followed by a randomized controlled study to evaluate the potentials but also the problems in the perioperative process.

Anaesthetic efficacy and postinduction hypotension with remimazolam compared with propofol: a multicentre randomised controlled trial.

Remimazolam, a short-acting benzodiazepine, may be used for induction and maintenance of total intravenous anaesthesia, but its role in the management of patients with multiple comorbidities remains unclear. In this phase 3 randomised controlled trial, we compared the anaesthetic efficacy and the incidence of postinduction hypotension during total intravenous anaesthesia with remimazolam vs. propofol. A total of 365 patients (ASA physical status 3 or 4) scheduled for elective surgery were assigned randomly to receive total intravenous anaesthesia with remimazolam (n = 270) or propofol (n = 95). Primary outcome was anaesthetic effect, quantified as the percentage of time with Narcotrend® Index values ≤ 60, during surgery (skin incision to last skin suture), with a non-inferiority margin of -10%. Secondary outcome was the incidence of postinduction hypotensive events. Mean (SD) percentage of time with Narcotrend Index values ≤ 60 during surgery across all patients receiving remimazolam (93% (20.7)) was non-inferior to propofol (99% (4.2)), mean difference (97.5%CI) -6.28% (-8.89-infinite); p = 0.003. Mean (SD) number of postinduction hypotension events was 62 (38.1) and 71 (41.1) for patients allocated to the remimazolam and propofol groups, respectively; p = 0.015. Noradrenaline administration events (requirement for a bolus and/or infusion) were also lower in patients allocated to remimazolam compared with propofol (14 (13.5) vs. 20 (14.6), respectively; p < 0.001). In conclusion, in patients who were ASA physical status 3 or 4, the anaesthetic effect of remimazolam was non-inferior to propofol.

[When emergency physician and tele-emergency physician save life together : A case description on the application of prehospital telemedicine for ventricular tachycardia with hemodynamic instability]. / Wenn Notarzt und Telenotarzt gemeinsam Leben retten : Eine Fallbeschreibung für die Anwendung der prähospitalen Telemedizin bei einer kreislaufinstabilen ventrikulären Tachykardie.

Telemedicine has already entered the rescue service in some regions of Germany. This case description is about a telemedical emergency physician case where an emergency doctor was also at the scene of the emergency. The patient had a life-threatening ventricular tachycardia and became hemodynamically unstable. The emergency physician was still inexperienced and overwhelmed by the complex situation. She decided to contact the tele-emergency medical services (tele-ems) and could then be instructed to perform intraosseous access, drug treatment and electrical cardioversion in the unstable patient. The cooperation with the tele-ems physician enabled the still inexperienced emergency physician to perform a guideline-compliant treatment and to transport the stabilized patient to the hospital in a timely manner.

Implementation of anesthesia quality indicators in Germany : A prospective, national, multicenter quality improvement study.

BACKGROUND: In 2016 the German Society of Anesthesiology and Intensive Care Medicine (DGAI) and the Association of German Anesthetists (BDA) published 10 quality indicators (QI) to compare and improve the quality of anesthesia care in Germany. So far, there is no evidence for the feasibility of implementation of these QI in hospitals. OBJECTIVE: This study tested the hypothesis that the implementation of the 10 QI is feasible in German hospitals. MATERIAL AND METHODS: This prospective three-phase national multicenter quality improvement study was conducted in 15 German hospitals and 1 outpatient anesthesia center from March 2017 to February 2018. The trial consisted of an initial evaluation of pre-existing structures and processes by the heads of the participating anesthesia departments, followed by a 6-month implementation phase of the QI as well as a final re-evaluation phase. The implementation procedure was supported by web-based implementation aids ( www.qi-an.org ) and internal quality management programs. The primary endpoint was the difference in the number of implemented QI per center before and after implementation. Secondary endpoints were the number of newly implemented QI per center, the overall number of successful implementations of each QI, the identification of problems during the implementation as well as the kind of impediments preventing the QI implementation. RESULTS: The average number of implemented QI increased from 5.8 to 6.8 (mean of the differences 1.1 ± 1.3; P < 0.01). Most frequently the QI perioperative morbidity and mortality report (5 centers) and the QI temperature management (4 centers) could be implemented. After the implementation phase, the QI incidence management and patient blood management were implemented in all 16 centers. Implementation of other quality indicators failed mainly due to a lack of time and lack of structural resources. CONCLUSION: In this study the implementation of QI was proven to be mostly feasible in the participating German hospitals. Although several QI could be implemented with minor effort, more time, financial and structural resources would be required for some QI, such as the QI postoperative visit.

[Implementation of anesthesia quality indicators in Germany : A prospective, national, multicenter quality improvement study]. / Implementierung anästhesiologischer Qualitätsindikatoren in Deutschland : Eine prospektive, nationale, multizentrische Qualitätssteigerungsstudie German version.

BACKGROUND: In 2016 the German Society of Anesthesiology and Intensive Care Medicine (DGAI) and the Association of German Anesthetists (BDA) published 10 quality indicators (QI) to compare and improve the quality of anesthesia care in Germany. So far, there is no evidence for the feasibility of implementation of these QI in hospitals. OBJECTIVE: This study tested the hypothesis that the implementation of the 10 QI is feasible in German hospitals. MATERIAL AND METHODS: This prospective three-phase national multicenter quality improvement study was conducted in 15 German hospitals and 1 outpatient anesthesia center from March 2017 to February 2018. The trial consisted of an initial evaluation of pre-existing structures and processes by the heads of the participating anesthesia departments, followed by a 6-month implementation phase of the QI as well as a final re-evaluation phase. The implementation procedure was supported by web-based implementation aids ( www.qi-an.org ) and internal quality management programs. The primary endpoint was the difference in the number of implemented QI per center before and after implementation. Secondary endpoints were the number of newly implemented QI per center, the overall number of successful implementations of each QI, the identification of problems during the implementation as well as the kind of impediments preventing the QI implementation. RESULTS: The average number of implemented QI increased from 5.8 to 6.8 (mean of the differences 1.1 ± 1.3; P < 0.01). Most frequently the QI perioperative morbidity and mortality report (5 centers) and the QI temperature management (4 centers) could be implemented. After the implementation phase, the QI incidence management and patient blood management were implemented in all 16 centers. Implementation of other quality indicators failed mainly due to a lack of time and lack of structural resources. CONCLUSION: In this study the implementation of QI was proven to be mostly feasible in the participating German hospitals. Although several QI could be implemented with minor effort, more time, financial and structural resources would be required for some QI, such as the QI postoperative visit.

[Appropriate allocation of resources for interhospital transfer in emergency medical service-is a physician in the dispatch center helpful?] / Indikationsgerechte Durchführung von Sekundärtransporten im Rettungsdienst ­ Hilft der Arzt in der Leitstelle?

BACKGROUND: The number of interhospital transfers is constantly increasing because of specialization of medical facilities, capacity balancing between intensive care units as well as earlier rehabilitation procedures. This leads to an increase in requests for emergency physicians to accompany patient transfers. This study investigated whether clarification of interhospital transport by an emergency physician at the dispatch center can optimize the use of emergency services resources. METHOD: All transport clarifications performed by a tele-emergency physician between 1 January 2018 and 31 December 2019 were retrospectively analyzed as well as the transport request forms. Furthermore, all data on the number and alarmed rescue resources for interhospital transfers in the city of Aachen from 2013 onwards were exported from the dispatch center databank and included in the evaluation. RESULTS: In total 2333 requests for interhospital patient transfers from 2018 and 2019 were analyzed as well as 10,923 transports recorded from 2013 to 2019. The number of patient transfers accompanied by an emergency physician from 2013 to 2019 was significantly reduced from 786 (68.2%) to 495 (30.5%, p > 0.001). The correct resources of rescue vehicles and staff was requested in 1816 cases (77.8%). The urgency of emergency patient transfers was correctly evaluated in 567 (89.2%) cases. In total 526 assignments were carried out without an emergency physician and 315 of these patients were accompanied by a tele-emergency physician during transfer. CONCLUSION: The immediate clarification of interhospital transport requests by an emergency physician at the dispatch center leads to a significant reduction in unnecessary medical accompaniment of patient transfers. The choice of an appropriate transfer vehicle and staff should not be left to the requesting hospital physician alone.

A systematic review of phenylephrine vs. noradrenaline for the management of hypotension associated with neuraxial anaesthesia in women undergoing caesarean section.

Phenylephrine is recommended for the management of hypotension after spinal anaesthesia in women undergoing caesarean section. Noradrenaline, an adrenergic agonist with weak ß-adrenergic activity, has been reported to have a more favourable haemodynamic profile than phenylephrine. However, there are concerns that noradrenaline may be associated with a higher risk of fetal acidosis, defined as an umbilical artery pH < 7.20. We performed a systematic review of trials comparing noradrenaline with phenylephrine, concentrating on primary outcomes of fetal acidosis and maternal hypotension. We identified 13 randomised controlled trials including 2002 patients. Heterogeneity among the studies was high, and there were too few data to calculate a pooled effect estimate. Fetal acidosis was assessed in four studies that had a low risk of bias and a low risk of confounding, that is, studies which used a prophylactic vasopressor and where women received the allocated vasopressor only. There were no significant differences between these studies. No significant differences were observed for hypotension. Two trials found a significantly lower incidence of bradycardia when using noradrenaline. Cardiac output was significantly higher after noradrenaline in two of three studies. For other secondary outcomes including nausea, vomiting and Apgar scores at 1 and 5 min, no studies found significant differences. The evidence so far is too limited to support an advantage of noradrenaline over phenylephrine. Concerns of a deleterious effect of noradrenaline on fetal blood gas status cannot currently be assuaged by the available data from randomised controlled studies.

Intrathecal catheterisation after observed accidental dural puncture in labouring women: update of a meta-analysis and a trial-sequential analysis.

BACKGROUND: Our meta-analysis from 2013 showed that inserting a catheter intrathecally after an observed accidental dural puncture can reduce the need for epidural blood patch in labouring women requesting epidural analgesia. We updated our conventional meta-analysis and added a trial-sequential analysis (TSA). METHODS: A systematic literature search was conducted to identify studies that compared inserting the catheter intrathecally with an epidural catheter re-site or with no intervention. The extracted data were pooled and the risk ratio (RR) and 95% confidence interval (95%CI) for the incidence of post-dural puncture headache (PDPH) was calculated, using the random effects model. A contour-enhanced funnel plot was constructed. A TSA was performed and the cumulative Z score, monitoring and futility boundaries were constructed. RESULTS: Our search identified 13 studies, reporting on 1653 patients, with a low risk of bias. The RR for the incidence of PDPH was 0.82 (95%CI 0.71 to 0.95) and the RR for the need for epidural blood patch was 0.62 (95%CI 0.49 to 0.79); heterogeneity of both analyses was high. The TSA showed that the monitoring or futility boundaries were not crossed, indicating insufficient data to exclude a type I error of statistical analysis. Contour-enhanced funnel plots were symmetric, suggesting no publication bias. CONCLUSIONS: Conventional meta-analyses showed for the first time that intrathecal catheterisation can reduce the incidence of PDPH. However, TSA did not corroborate this finding. Despite increasing use in clinical practice there is no firm evidence on which to base a definite conclusion.

[Analgesia in the emergency medical service: comparison between tele-emergency physician and call back procedure with respect to application safety, effectiveness and tolerance]. / Analgesie im Rettungsdienst: Vergleich zwischen Telenotarzt- und Callback-Verfahren hinsichtlich Anwendungssicherheit, Wirksamkeit und Verträglichkeit.

BACKGROUND: Acute pain is a common reason for calling emergency medical services (EMS) and can require medication depending on the pain intensity. German EMS personnel feel strong pressure to reduce a patient's pain but are restricted by law. Currently, German federal law only allows the administration of opioid-containing drugs by or on the order of a physician, while in other European countries (e.g. Switzerland and The Netherlands) the administration of opioid-based analgesia by trained and certified paramedics is common practice. Consequently, a patient in Germany experiencing acute pain needs the attendance of an emergency physician in EMS missions. According to international standards pain reduction on the numeric rating scale (NRS) score by ≥2 or a NRS score ≤4 at the end of the patient transport is considered to be adequate. OBJECTIVE: Comparison of two different algorithm-based concepts for analgesia with consultation of a physician analyzing the efficacy, tolerance and safety of application. MATERIAL AND METHODS: In a retrospective cohort study in two different regions, two physician-supported algorithm-based analgesia concepts, a call back-supported concept (EMS Schleswig-Holstein: RKiSH) and a tele-EMS physician-based concept (EMS Aachen: RDAC), were compared over 2 years. The call back-supported concept is based on specific algorithms and certification of EMS personnel. In Aachen, the tele-EMS physician is integrated into the routine EMS system and includes immediate vital data transmission. RESULTS: Over a period of 2 years call back-supported analgesia was administered in 878 cases (2016: 428, 2017: 450) and telemedically assisted analgesia was used in 728 cases (2015: 226, 2016: 502). Call back vs. telemedicine: initial NRS scores were 9 (8-10) and 8 (6-9), respectively (p < 0.0001); NRS scores were reduced by 4 (3-5) and 5 (3-6), respectively (p = 0.0002), leading to mean NRS scores of 4 (3-6) vs. 3 (2-4), respectively (p < 0.0001) at patient handover/emergency room arrival. Clinically relevant pain reduction was achieved in both groups. Complete NRS documentation was conducted in 753 (85.8%) vs. 673 (92.4%) cases, respectively, p = 0. Severe adverse events did not occur in either of the groups. CONCLUSION: The administration of analgesia by EMS personnel with teleconsultation of a physician is effective and has a low rate of complications, particularly morphine. Overall, algorithm-based call back-supported as well as telemedically supported analgesia concepts based on regular training improve the management of pain in the prehospital setting. In addition, the resources of the emergency physician remain available for life-threatening emergencies. The training, certification and supervision of EMS personnel is very important in both systems to ensure the best pain management care and patient safety. Adjustments to the federal law on the administration of analgesics would facilitate the realization of algorithm-based concepts by paramedics as pain reduction could be performed with delegation by a medical director without consulting another physician.

Dural puncture epidural versus conventional epidural block for labor analgesia: a systematic review of randomized controlled trials.

INTRODUCTION: Dural puncture epidural (DPE) analgesia is a modification of conventional epidural analgesia that involves the intentional puncture of the dura with a spinal needle through the needle placed in the epidural space, without a medication being injected intrathecally. There have been contradictory findings regarding better analgesia and better block quality. METHODS: A systematic literature search was done to identify randomized controlled trials (RCT) comparing DPE with epidural analgesia. The risk of bias was assessed with the Cochrane tool. Risk ratio and 95% confidence intervals were calculated. RESULTS: Five RCTs including 581 patients were identified. One RCT on caesarean section was excluded. Single studies suggested slightly better analgesia by finding a median time to achieve sufficient analgesia of two minutes less in the DPE group, a higher number of women having a pain score <10/100 at 20 min, a reduction in the number of epidural top-ups and better sacral spread. The studies did not show a difference between DPE and epidural analgesia for catheter replacement or manipulation rates, the incidence of intravascular placement or unilateral block. CONCLUSION: There is a lack of clear evidence on either the benefits or therisks of the DPE technique, such that a recommendation for or against its routine use is premature. Two of the three studies showing a beneficial effect of DPE came from the same institution and replication of the findings by other groups is warranted.

Effect of Intraoperative High Positive End-Expiratory Pressure (PEEP) With Recruitment Maneuvers vs Low PEEP on Postoperative Pulmonary Complications in Obese Patients: A Randomized Clinical Trial.

Importance: An intraoperative higher level of positive end-expiratory positive pressure (PEEP) with alveolar recruitment maneuvers improves respiratory function in obese patients undergoing surgery, but the effect on clinical outcomes is uncertain. Objective: To determine whether a higher level of PEEP with alveolar recruitment maneuvers decreases postoperative pulmonary complications in obese patients undergoing surgery compared with a lower level of PEEP. Design, Setting, and Participants: Randomized clinical trial of 2013 adults with body mass indices of 35 or greater and substantial risk for postoperative pulmonary complications who were undergoing noncardiac, nonneurological surgery under general anesthesia. The trial was conducted at 77 sites in 23 countries from July 2014-February 2018; final follow-up: May 2018. Interventions: Patients were randomized to the high level of PEEP group (n = 989), consisting of a PEEP level of 12 cm H2O with alveolar recruitment maneuvers (a stepwise increase of tidal volume and eventually PEEP) or to the low level of PEEP group (n = 987), consisting of a PEEP level of 4 cm H2O. All patients received volume-controlled ventilation with a tidal volume of 7 mL/kg of predicted body weight. Main Outcomes and Measures: The primary outcome was a composite of pulmonary complications within the first 5 postoperative days, including respiratory failure, acute respiratory distress syndrome, bronchospasm, new pulmonary infiltrates, pulmonary infection, aspiration pneumonitis, pleural effusion, atelectasis, cardiopulmonary edema, and pneumothorax. Among the 9 prespecified secondary outcomes, 3 were intraoperative complications, including hypoxemia (oxygen desaturation with Spo2 ≤92% for >1 minute). Results: Among 2013 adults who were randomized, 1976 (98.2%) completed the trial (mean age, 48.8 years; 1381 [69.9%] women; 1778 [90.1%] underwent abdominal operations). In the intention-to-treat analysis, the primary outcome occurred in 211 of 989 patients (21.3%) in the high level of PEEP group compared with 233 of 987 patients (23.6%) in the low level of PEEP group (difference, -2.3% [95% CI, -5.9% to 1.4%]; risk ratio, 0.93 [95% CI, 0.83 to 1.04]; P = .23). Among the 9 prespecified secondary outcomes, 6 were not significantly different between the high and low level of PEEP groups, and 3 were significantly different, including fewer patients with hypoxemia (5.0% in the high level of PEEP group vs 13.6% in the low level of PEEP group; difference, -8.6% [95% CI, -11.1% to 6.1%]; P < .001). Conclusions and Relevance: Among obese patients undergoing surgery under general anesthesia, an intraoperative mechanical ventilation strategy with a higher level of PEEP and alveolar recruitment maneuvers, compared with a strategy with a lower level of PEEP, did not reduce postoperative pulmonary complications. Trial Registration: ClinicalTrials.gov Identifier: NCT02148692.

Effect of intravenous dexamethasone on postoperative pain after spinal anaesthesia - a systematic review with meta-analysis and trial sequential analysis.

There are data suggesting that intravenous dexamethasone has an effect on postoperative analgesia when given during single-shot spinal anaesthesia. However, the research literature is equivocal. We performed a systematic literature search followed by conventional meta-analysis (random effects model). We used trial sequential analysis to control for type-1 and -2 statistical errors. We also performed a leave-one-out meta-analysis for our primary outcome, the consumption of intravenous morphine in the first 24 postoperative hours. We applied the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system to rate the level of evidence. We obtained data from 1133 patients, reported in 17 trials. Reporting quality was high, with low risk of bias. Dexamethasone use was associated with a significant reduction in 24-h morphine consumption, the mean difference (95%CI) being -4.01 (-5.01 to -3.01) mg, 6 trials, 326 participants, I2 = 0%. Trial sequential analysis showed that there was firm evidence for the primary outcome, and leave-one-out meta-analysis showed that our result was not driven by one single trial. The GRADE evaluation showed a high level of evidence, suggesting that further studies are unlikely to alter the result. The time to first analgesic request (95%CI) was significantly prolonged by 86.62 (10.62-162.62) min, I2 = 93%, in the dexamethasone group. For other secondary outcomes including number of patients requiring rescue analgesia, or visual analogue scale pain scores, we found no evidence of a significant difference between the treatment arms. We report a high level of evidence that intravenous dexamethasone improves postoperative analgesia after spinal anaesthesia.

Correction to: Protective ventilation with high versus low positive end-expiratory pressure during one-lung ventilation for thoracic surgery (PROTHOR): study protocol for a randomized controlled trial.

After publication of the original article [1], the authors have notified us that two of the collaborator first and last names have been inverted in the "PROTHOR Investigators" table.

Protective ventilation with high versus low positive end-expiratory pressure during one-lung ventilation for thoracic surgery (PROTHOR): study protocol for a randomized controlled trial.

BACKGROUND: Postoperative pulmonary complications (PPC) may result in longer duration of in-hospital stay and even mortality. Both thoracic surgery and intraoperative mechanical ventilation settings add considerably to the risk of PPC. It is unclear if one-lung ventilation (OLV) for thoracic surgery with a strategy of intraoperative high positive end-expiratory pressure (PEEP) and recruitment maneuvers (RM) reduces PPC, compared to low PEEP without RM. METHODS: PROTHOR is an international, multicenter, randomized, controlled, assessor-blinded, two-arm trial initiated by investigators of the PROtective VEntilation NETwork. In total, 2378 patients will be randomly assigned to one of two different intraoperative mechanical ventilation strategies. Investigators screen patients aged 18 years or older, scheduled for open thoracic or video-assisted thoracoscopic surgery under general anesthesia requiring OLV, with a maximal body mass index of 35 kg/m2, and a planned duration of surgery of more than 60 min. Further, the expected duration of OLV shall be longer than two-lung ventilation, and lung separation is planned with a double lumen tube. Patients will be randomly assigned to PEEP of 10 cmH2O with lung RM, or PEEP of 5 cmH2O without RM. During two-lung ventilation tidal volume is set at 7 mL/kg predicted body weight and, during OLV, it will be decreased to 5 mL/kg. The occurrence of PPC will be recorded as a collapsed composite of single adverse pulmonary events and represents the primary endpoint. DISCUSSION: PROTHOR is the first randomized controlled trial in patients undergoing thoracic surgery with OLV that is adequately powered to compare the effects of intraoperative high PEEP with RM versus low PEEP without RM on PPC. The results of the PROTHOR trial will support anesthesiologists in their decision to set intraoperative PEEP during protective ventilation for OLV in thoracic surgery. TRIAL REGISTRATION: The trial was registered in clinicaltrials.gov ( NCT02963025 ) on 15 November 2016.