Perioperative patient outcome in anaesthesia

Background\ud \ud Patient satisfaction with anaesthesia is an important but complex measure. However, there are only a few appropriate psychometrically designed instruments that contain items on all important factors. Psychometric instruments providing information about satisfaction in children are completely missing. Thus, a need for sound psychometrical instruments to assess satisfaction with anaesthesia care in the German adult and paediatric patient population exists.\ud \ud Anaesthesia is a high risk medical profession and it is important to evaluate severe incident, events and complications (IEC) including deaths that occur. Details about the anaesthetic risks are an important part of the anaesthetic consult. There is no standardised worldwide registry system and a lack of thorough reported data on critical IEC or deaths, hence, debate over the incidence of anaesthesia-related mortality in the different countries continues and rates for anaesthesia-related severe IEC in Germany need to be evaluated.\ud \ud The aims of my studies were to develop measures for perianaesthetic satisfaction in adult and paediatric patients, as well as to determine the rate of severe IEC attributable to anaesthesia in Germany.\ud \ud Specific aims of the studies presented in this thesis:\ud \ud Satisfaction\ud \ud • To develop perianaesthetic questionnaires for adult and paediatric patients that adhere to a strict psychometric design\ud \ud • To compare satisfaction with anaesthesia between participating hospitals, in paediatric patients with/without disabilities and existing questionnaires\ud \ud • To analyse the anaesthesia pre-operative evaluation clinic (APEC) and the ward with regard to time (costs), information gain and patient satisfaction\ud \ud IEC (incidents, events and complications)\ud \ud • To evaluate the general quality of the collected (core) data (set) (CDS), the frequency of coding errors in American Society of Anaesthesiologists Physical Status (ASA PS) 1 and 2 Patients and to identify filtering methods that could be used in future studies\ud \ud • To elucidate the underlying mechanisms of the severe IEC\ud \ud • To assess the frequency of severe IEC in healthy patients in the whole dataset and the anaesthetic contributions\ud \ud Methods\ud \ud The thesis comprises the results of eight dedicated studies. One regional, one national, and one paediatric questionnaire were developed based on a sound psychometric design to assess patient satisfaction with anaesthesia. This included patients' involvement, cognitive and pilot testing, validation for validity and reliability, and the adjustment for confounding variables. The basis of this thesis is the multicentre development of the Heidelberg Perianaesthetic Questionnaire (HPQ). Five of the studies presented are directly linked to or are using the findings and experiences made in this study.\ud \ud The questionnaires were used to test the performance of an APEC, to benchmark hospitals, as well as to test satisfaction between different patient groups. IEC were assessed in the CDS, which is in use as a national surveillance system. A first study identified rather healthy patients displaying severe IEC. The frequency of coding errors in the dataset between 2002 and 2004 was determined by matching the cases to more detailed reports received by mail from the participating anaesthetic departments, and the nature of IEC were analysed. Filtering methods to analyse a large set of data with more than 4 million anaesthetic records were employed. In this second study, the incidence of severe IECs in healthy patients was determined. Cases where the underlying (IEC) codes suggested direct anaesthetic involvement were identified and analysed through normative discussion groups.\ud \ud Overall results and conclusions of the studies presented in this thesis\ud \ud My psychometric questionnaires were used to evaluate satisfied and dissatisfied groups and to benchmark satisfaction with anaesthesia care at different hospitals. The main areas where satisfaction may be improved include patient information, preparation for anaesthesia, as well as discomfort and its treatment. Satisfaction with anaesthesia was lower in the groups of children with disabilities as compared to non-disabled. Negative comments related to the anaesthetists' behaviour, the anaesthetic consultation, and anxiety.\ud \ud Another study that co-and cross-validated a translated French questionnaire found that instruments should best be constructed and validated within the same socio-cultural background. Assessment of the anaesthetic consult found favourable results in terms of time spent for the consult with the patient and amount of information passed on to the patients for the APEC compared to the ward.\ud \ud The studies using the CDS provide detailed data on the topic of severe IEC including death. Coding errors were encountered with a frequency of nearly 50%. Most reported events (IEC) were related to patient, surgical or procedural risks, 15% were noticeable or conspicuous events. The rate of major morbidity/mortality was about 3 per 100,000, the anaesthetic contribution was about 1 per 100,000 case sin healthy patients.\ud \ud Overall relevance of the studies presented in this thesis\ud \ud My studies presented here constitute a sound psychometric approach to the development of instruments for the measurement of patients' satisfaction with anaesthesia and the first worldwide for paediatric patients. The questionnaires presented are valid and reliable tools and thus hold the key to essential feedback data from patients for the identification of specific areas where improvement in patient care can be achieved. The relevance of the developed tools presented in this thesis is highlighted by the fact that all questionnaires have already found entry to routine clinical use at various hospitals worldwide.\ud \ud My studies also provided sound evidence that an APEC substantially improves the cost efficiency and the delivery of comprehensive information to the patients during the anaesthetic consult. In the light of cost containment discussions with time restraints in patient care, this is an important finding.\ud \ud The studies using the CDS provide the first reliable data on the frequency of severe anaesthesia-related IEC and death for Germany, holding the key for national monitoring and international comparison of rates. While they indicate low rates of anaesthesia-related IEC, measures to improve the quality of the CDS data need to be adopted, facts that have been presented at various national and international conferences

Short term cognitive function after sevoflurane anesthesia in patients suspect to obstructive sleep apnea syndrome: an observational study

Background!#!The obstructive sleep apnea syndrome (OSAS) is characterized by intermittent cerebral hypoxia which can cause cognitive alterations. Likewise, hypoxia induced neurocognitive deficits are detectable after general anesthesia using volatile anesthetics. The objective of this study was to evaluate the association between a moderate to high risk patients of OSAS and postoperative cognitive dysfunction after volatile anesthesia.!##!Methods!#!In this single center prospective, observational study between May 2013 and September 2013, 46 patients aged 55 to 80 years with an estimated hospital stay of at least 3 days undergoing surgery were enrolled. Patients were screened using the STOP-BANG test with score of 3 or higher indicating moderate to high risk of OSAS. The cognitive function was assessed using a neuropsychological assessment battery, including the DemTect test for cognitive impairment among other tests e.g. SKT memory, the day before surgery and within 2 days after extubation.!##!Results!#!Twenty-three of the 46 analyzed patients were identified with a moderate to high risk of OSAS. When comparing post- to preoperative phase a significant better performance for the SKT was found for both groups (p <  0.001). While the moderate to high risk group scores increased postoperative in the DemTect test, they decreased in the low risk group (p <  0.003). When comparing the changes between groups, the moderate to high risk patients showed significant better test result for DemTect testing after anaesthesia. This effect remained robust when adjusting for potential confounding variables using a two-factor ANOVA.!##!Conclusion!#!Compared to low risk, a moderate to high risk of OSAS based on the STOP-BANG score was associated with improved postoperative cognitive function measured by the DemTect test.!##!Trial registration!#!The study was approved by the local Ethics committee (Ethikkommission der Medizinischen Fakultät der Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany) (reference number: 87_12 B ) on 19.04.2012

Major incidents and complications in otherwise healthy patients undergoing elective procedures: results based on 1.37 million anaesthetic procedures

Background: Improved anaesthesia safety has made severe anaesthesia-related incidents, complications, and deaths rare events, but concern about morbidity and mortality in anaesthesia continues. This study examines possible severe adverse outcomes or death recorded in a large national surveillance system based on a core data set (CDS). Methods: Cases from 1999 to 2010 were filtered from the CDS database. Cases were defined as elective patients classified as ASA physical status grades I and II (without relevant risk factors) resulting in death or serious complication. Four experts reviewed the cases to determine anaesthetic involvement. Results: Of 1 374 678 otherwise healthy, ASA I and II patients in the CDS database, 36 met the study inclusion criteria resulting in a death or serious complication rate of 26.2 per million [95% confidence interval (CI), 19.4–34.6] procedures, and for those with possible direct anaesthetic involvement, 7.3 per million cases (95% CI, 3.9–12.3). Conclusions: This is the first study assessing severe incidents and complications from a national outcome-tracking database. Annual identification and review of cases, perhaps with standardized database queries in the respective departments, might provide more detailed information about the cascades that lead to unfortunate outcomes

Gastrointestinal Complications After Pancreatoduodenectomy With Epidural vs Patient-Controlled Intravenous Analgesia: A Randomized Clinical Trial

IMPORTANCE Morbidity is still high in pancreatic surgery, driven mainly by gastrointestinal complications such as pancreatic fistula. Perioperative thoracic epidural analgesia (EDA) and patient-controlled intravenous analgesia (PCIA) are frequently used for pain control after pancreatic surgery. Evidence from a post hoc analysis suggests that PCIA is associated with fewer gastrointestinal complications.OBJECTIVE To determine whether postoperative PCIA decreases the occurrence of gastrointestinal complications after pancreatic surgery compared with EDA.DESIGN, SETTING, AND PARTICIPANTS In this adaptive, pragmatic, international, multicenter, superiority randomized clinical trial conducted from June 30, 2015, to October 1, 2017, 371 patients at 9 European pancreatic surgery centers who were scheduled for elective pancreatoduodenectomy were randomized to receive PCIA (n = 185) or EDA (n = 186); 248 patients (124 in each group) were analyzed. Data were analyzed from February 22 to April 25, 2019, using modified intention to treat and per protocol.INTERVENTIONS Patients in the PCIA group received general anesthesia and postoperative PCIA with intravenous opioids with the help of a patient-controlled analgesia device. In the EDA group, patients received general anesthesia and intraoperative and postoperative EDA.MAIN OUTCOMES AND MEASURES The primary end point was a composite of pancreatic fistula, bile leakage, delayed gastric emptying, gastrointestinal bleeding, or postoperative ileus within 30 days after surgery. Secondary end points included 30-day mortality, other complications, postoperative pain levels, intraoperative or postoperative use of vasopressor therapy, and fluid substitution.RESULTS Among the 248 patients analyzed (147 men; mean [SD] age, 64.9 [10.7] years), the primary composite end point did not differ between the PCIA group (61 [49.2%]) and EDA group (57 [46.0%]) (odds ratio, 1.17; 95% CI, 0.71-1.95 P = .54). Neither individual components of the primary end point nor 30-day mortality, postoperative pain levels, or intraoperative and postoperative substitution of fluids differed significantly between groups. Patients receiving EDA gained more weight by postoperative day 4 than patients receiving PCIA (mean [SD], 4.6 [3.8] vs 3.4 [3.6] kg; P = .03) and received more vasopressors (46 [37.1%] vs 31[25.0%1 P = .04). Failure of EDA occurred in 23 patients (18.5%).CONCLUSIONS AND RELEVANCE This study found that the choice between PCIA and EDA for pain control after pancreatic surgery should not be based on concerns regarding gastrointestinal complications because the 2 procedures are comparable with regard to effectiveness and safety. However, EDA was associated with several shortcomings