Translation and Psychometric Testing of the Hägerbäumer Presenteeism Scale in English.

PURPOSE: Interest in presenteeism has increased in research. Presenteeism is a behaviour of going to work despite illness. It has been predominantly measured using single items, which introduce limitations to validity. To overcome these limitations, Hägerbäumer developed a German multi-item presenteeism scale. METHODS: The aim of the study was to provide an English translation and psychometric testing of the scale. This was conducted in two phases with native English-speaking employed adults. Phase 1 includes translation and cognitive debriefing, phase 2 testing construct validity and internal consistency reliability. RESULTS: Cognitive debriefing with 10 employees revealed no problems with understanding or answering the translated items. In total, 487 employed adults participated in the study, of which data from 287 were included in the analysis. For structural validity, the goodness-of-fit indicators all reached their thresholds (TLI = 0.98, CFI = 0.99, RMSEA = 0.07, SRMR = 0.02). The scale does not show differences between sexes and age groups but between sectors (F6,70.95 = 5.53, p < 0.001). The internal consistency reliability was satisfactory with α = 0.89 (CI 95%, 0.87-0.91). CONCLUSION: The translated multidimensional scale for measuring presenteeism at the behavioural level demonstrated good psychometric properties in an initial validation. Further psychometric testing is required before using this scale in cross-national comparison in research and international companies.

Therapeutic drug monitoring in children and adolescents with schizophrenia and other psychotic disorders using risperidone.

Risperidone is commonly used to treat different psychiatric disorders worldwide. Knowledge on dose-concentration relationships of risperidone treatment in children and adolescents with schizophrenia or other psychotic disorders is, however, scarce and no age-specific therapeutic ranges have been established yet. Multicenter data of a therapeutic drug monitoring service were analyzed to evaluate the relationship between risperidone dose and serum concentration of the active moiety (risperidone (RIS) plus its main metabolite 9-hydroxyrisperidone (9-OH-RIS)) in children and adolescents with psychotic disorders. Patient characteristics, doses, serum concentrations and therapeutic outcomes were assessed by standardized measures. The study also aimed to evaluate whether the therapeutic reference range for adults (20-60 ng/ml) is applicable for minors. In the 64 patients (aged 11-18 years) included, a positive correlation between daily dose and the active moiety (RISam) concentration was found (rs = 0.49, p = 0.001) with variation in dose explaining 24% (rs2 = 0.240) of the variability in serum concentrations. While the RISam concentration showed no difference, RIS as well 9-OH-RIS concentrations and the parent to metabolite ratio varied significantly in patients with co-medication of a CYP2D6 inhibitor. Patients with extrapyramidal symptoms (EPS) had on average higher RISam concentrations than patients without (p = 0.05). Considering EPS, the upper threshold of the therapeutic range of RISam was determined to be 33 ng/ml. A rough estimation method also indicated a possibly decreased lower limit of the preliminary therapeutic range in minors compared to adults. These preliminary data may contribute to the definition of a therapeutic window in children and adolescents with schizophrenic disorders treated with risperidone. TDM is recommended in this vulnerable population to prevent concentration-related adverse drug reactions.

Effectiveness of parathyroid hormone (PTH) analogues on fracture healing: a meta-analysis.

This meta-analysis evaluated the evidence for the use of parathyroid hormone (PTH) analogues to improve fracture healing. Eligible studies were prospective randomised controlled trials of adults with acute fractures treated with a PTH analogue. PTH improved functional outcomes but did not affect fracture healing rate or reduce pain. PURPOSE: This meta-analysis evaluated the evidence of parathyroid hormone (PTH) analogues in fracture healing. The use of PTH analogues to prevent osteoporotic fractures is well investigated, and studies are emerging on extended indications. One such indication receiving increasing attention is the effect of PTH in fracture healing; however, the overall degree of efficacy remains inconclusive. METHODS: A systematic electronic database search of MEDLINE, EMBASE and the Cochrane Library was conducted for relevant articles in August 2019 with no date restrictions. Randomised controlled trials of adults with acute fractures treated with a PTH analogue were included. PTH was compared with a comparator intervention, placebo or no treatment. RESULTS: PTH analogue treatment improved functional outcomes in a range of fracture types but did not affect the fracture healing rate or reduce pain. Most trials included in this review were in elderly patients with osteoporosis. There was no evidence that PTH treatment caused harm or impeded fracture healing. CONCLUSIONS: Meta-analysis of published data supports the use of PTH analogues to improve functional outcomes but not fracture healing rate or pain for different fracture types. The evidence for PTH analogue use in fracture healing is less clear in younger, non-osteoporotic patient populations. Trial design was heterogeneous and of limited quality, justifying further original trials.

Estimation of a preliminary therapeutic reference range for children and adolescents with tic disorders treated with tiapride.

PURPOSE: Tiapride is commonly used in Europe for the treatment of tics. The aim of this study was to examine the relationship between dose and serum concentrations of tiapride and potential influential pharmacokinetic factors in children and adolescents. In addition, a preliminary therapeutic reference range for children and adolescents with tics treated with tiapride was calculated. METHODS: Children and adolescents treated with tiapride at three university hospitals and two departments of child and adolescents psychiatry in Germany and Austria were included in the study. Patient characteristics, doses, serum concentrations, and therapeutic outcome were assessed during clinical routine care using standardised measures. RESULTS: In the 49 paediatric patients (83.7% male, mean age = 12.5 years), a positive correlation was found between tiapride dose (median 6.9 mg/kg, range 0.97-19.35) and serum concentration with marked inter-individual variability. The variation in dose explained 57% of the inter-patient variability in tiapride serum concentrations; age, gender, and concomitant medication did not contribute to the variability. The symptoms improved in 83.3% of the patients. 27.1% of the patients had mild or moderate ADRs. No patient suffered from severe ADRs. CONCLUSIONS: This study shows that tiapride treatment was effective and safe in most patients with tics. Compared with the therapeutic concentration range established for adults with Chorea Huntington, our data hinted at a lower lower limit (560 ng/ml) and similar upper limit (2000 ng/ml).

Consensus Guidelines for Therapeutic Drug Monitoring in Neuropsychopharmacology: Update 2017.

Therapeutic drug monitoring (TDM) is the quantification and interpretation of drug concentrations in blood to optimize pharmacotherapy. It considers the interindividual variability of pharmacokinetics and thus enables personalized pharmacotherapy. In psychiatry and neurology, patient populations that may particularly benefit from TDM are children and adolescents, pregnant women, elderly patients, individuals with intellectual disabilities, patients with substance abuse disorders, forensic psychiatric patients or patients with known or suspected pharmacokinetic abnormalities. Non-response at therapeutic doses, uncertain drug adherence, suboptimal tolerability, or pharmacokinetic drug-drug interactions are typical indications for TDM. However, the potential benefits of TDM to optimize pharmacotherapy can only be obtained if the method is adequately integrated in the clinical treatment process. To supply treating physicians and laboratories with valid information on TDM, the TDM task force of the Arbeitsgemeinschaft für Neuropsychopharmakologie und Pharmakopsychiatrie (AGNP) issued their first guidelines for TDM in psychiatry in 2004. After an update in 2011, it was time for the next update. Following the new guidelines holds the potential to improve neuropsychopharmacotherapy, accelerate the recovery of many patients, and reduce health care costs.

Prospective quality control study of a novel gravity-driven whole blood separation system suitable for humanitarian crises.

Centrifugation-based whole blood (WB) separation represents the worldwide standard but it depends on electricity and infrastructure. We have prospectively evaluated a novel hollow-fibre WB separation system that does not require manual priming or blood flow regulation (n = 29). RBC units contained sufficient Hb (50·4 g ± 4·3), low leucocytes (90 000 ± 0·008), exhibited low haemolysis (0·57% ± 0·49) and robust ATP content (51·47% ± 8·2) after 43 days storage. Plasma units contained low leucocytes and mean coagulation factor activities for FV, FVIII and FXI were 47%, 90% and 68%, respectively. RBC met quality specifications but plasma units exhibited reduced FV and FXI activity.

[Guidelines in Practice: The New S3 Guideline "Sleeping Disorders - Sleep-Related Abnormal Breathing"]. / Leitlinien in der Praxis: Die neue S3-Leitlinie "Nicht erholsamer Schlaf/Schlafstörungen" ­ Kapitel "Schlafbezogene Atmungsstörungen".

Sleep related breathing disorders include central sleep apnea (CSA), obstructive sleep apnea (OSA), sleep-related hypoventilation, and sleep-related hypoxia. These disorders are frequent and growing in clinical relevance. The related chapter of the S3 guideline "Non-restorative sleep/Sleep disorders", published by the German Sleep Society (DGSM), has recently been updated in November 2016. Epidemiology, diagnostics, therapeutic procedures, and classification of sleep related disorders have been revised. Concerning epidemiology, a considerably higher mortality rate among pregnant women with OSA has been emphasized. With regards to diagnostics, the authors point out that respiratory polygraphy may be sufficient in diagnosing OSA, if a typical clinical condition is given. For CSA, recommendations were changed to diagnose CSA with low apnea rates present. Significant changes for treating CSA in patients with left ventricular dysfunction have been introduced. In addition, there is now to be differentiated between sleep-related hypoventilation and sleep-related hypoxaemia. Obesity hypoventilation syndrome is discussed in more detail. This article sums up and comments on the published changes.

Trust, but verify. The errors and misinterpretations in the Cochrane analysis by O. J. Storebo and colleagues on the efficacy and safety of methylphenidate for the treatment of children and adolescents with ADHD.

Objective: A recent Cochrane review published by O. J. Storebo and colleagues (2015) raised substantial doubts about the benefit from stimulant medication with methylphenidate in the treatment of childhood ADHD due to the overall poor quality of studies. The systematic review thus contradicts all previous reviews and meta-analyses. Method: We here detail various examples of errors, inconsistencies, and misinterpretations in the review which led to false results and inadequate conclusions. Results: We demonstrate that the study selection is flawed and undertaken without sufficient scientific justification resulting in an underestimation of effect sizes, which, furthermore, are inadmissibly clinically interpreted. The methodology of the assessment of bias and quality is not objective and cannot be substantiated by the data. Conclusions: Cochrane reviews lay claim to a high scientific quality and substantial relevance for evidence-based clinical decisions. The systematic review by Storebo and colleagues (2015) illustrates that, despite adhering to strict standards and high-quality protocols, even Cochrane works should be critically read and verified, sometimes with surprising results.

Slice cultures from head and neck squamous cell carcinoma: a novel test system for drug susceptibility and mechanisms of resistance.

BACKGROUND: Human head and neck squamous cell carcinoma (HNSCC) fundamentally vary in their susceptibility to different cytotoxic drugs and treatment modalities. There is at present no clinically accepted test system to predict the most effective therapy for an individual patient. METHODS: Therefore, we established tumour-derived slice cultures which can be kept in vitro for at least 6 days. Upon treatment with cisplatin, docetaxel and cetuximab, slices were fixed and paraffin sections were cut for histopathological analysis. RESULTS: Apoptotic fragmentation, activation of caspase 3, and cell loss were observed in treated tumour slices. Counts of nuclei per field in untreated compared with treated slices deriving from the same tumour allowed estimation of the anti-neoplastic activity of individual drugs on an individual tumour. CONCLUSION: HNSCC-derived slice cultures survive well in vitro and may serve not only to improve personalised therapies but also to detect mechanisms of tumour resistance by harvesting surviving tumour cells after treatment.

Pre-hospital discharge testing after implantable cardioverter defibrillator implantation: a measure of safety or out of date? A retrospective analysis of 975 patients.

AIMS: The present study evaluates the relevance and additional safety value of pre-hospital discharge (PHD) testing in patients with implantable cardioverter defibrillator (ICD) therapy. METHODS: From June 1998 to May 2009, 975 patients (830 male, 145 female) with ICD were screened retrospectively for failed PHD and analysed for its consequences, risk factors, and patient characteristics after successful intra-operative testing in the implantation procedure. RESULTS: Pre-hospital discharge testing procedure was performed in 809 cases. No serious adverse events (e.g. death, persistant ventricular fibrillation or ventricular tachycardia, stroke) occurred. The overall incidence of failed PHD was 1.4% (n = 11). The underlying mechanisms were defibrillation threshold failure in 9/11 cases and sensing failure in 2/11 cases. CONCLUSIONS: In this study predictors for PHD-failure are: (i) cardiomyopathy other than ischaemic or dilative, (ii) young age, and (iii) small or very large left ventricular end-diastolic diameter ( < 40 or > 65 mm). Particularly, (i) manufacture of device or leads, (ii) lead design, (iii) medical treatment, or (iv) gender have no significant influence on PHD failure.

Therapeutic drug monitoring of children and adolescents treated with fluoxetine.

INTRODUCTION: Information about therapeutic serum levels of fluoxetine (FLX) and its major metabolite norfluoxetine (NORFLX) in children and adolescents is scarce. METHODS: Therapeutic drug monitoring (TDM) of FLX was routinely performed in 71 subjects treated for a major depressive disorder (MDD) (10-60 mg/d FLX, median: 20 mg/d). Correlations between serum concentration and dosage, age, gender, smoking habits and adverse events were analysed. RESULTS: Serum concentrations of the active moiety (FLX + NORFLX) ranged from 21 to 613 ng/mL (mean concentration of 213 ± 118 ng/mL, median: 185 ng/mL). High inter-individual variability in serum concentrations of the active moiety of FLX at each dosage level was observed and no relationship between serum concentration and clinical outcome was found. Apart from smoking, none of the factors tested had a significant eff ect on the serum concentration. DISCUSSION: It was shown that serum concentrations of the active moiety of FLX in children and adolescents seem to be similar to those in adults, with a high level of inter-individual variation. The proportion of patients who showed benefits from treatment with a dose of 20 mg/d FLX was high.

Threshold Photoelectron Spectrum of m-Benzyne.

Due to their unusual electronic structure, the biradical m-benzyne, C6H4, and its cation are of considerable interest in chemistry. Here, the photoion mass-selected threshold photoelectron spectrum of the m-benzyne biradical is presented. An adiabatic ionization energy of 8.65 ± 0.015 eV is derived, while a vibrational progression of 0.10 eV is assigned to the ν9+ ring breathing mode, in excellent agreement with computations. The experimental spectrum was reproduced well by Franck-Condon spectral modeling of the 2A1 ← X 1A1 transition, in which the cation retains a monocyclic C6 framework. The energetically close-lying bicyclic 2A2 cation state exhibits low Franck-Condon factors, due to the large change in geometry, and thus cannot be observed.

Transcriptional alterations under continuous or pulsatile dopaminergic treatment in dyskinetic rats.

Continuous dopaminergic treatment is considered to prevent or delay the occurrence of dyskinesia in patients with Parkinson's disease (PD). Rotigotine is a non-ergolinic D(3) > D(2) > D(1) dopamine-receptor agonist for the treatment of PD using a transdermal delivery system providing stable plasma levels. We aimed to investigate the differential influence on gene expression of pulsatile L: -DOPA or rotigotine versus a continuous rotigotine treatment. The gene expression profile within the nigro-striatal system of unilateral 6-hydroxydopamine-lesioned rats was assessed in order to differentiate potential changes in gene expression following the various treatment using Affymetrix microarrays and quantitative RT-PCR. The expression of 15 genes in the substantia nigra and of 11 genes in the striatum was altered under pulsatile treatments inducing dyskinetic motor response, but was unchanged under continuous rotigotine treatment that did not cause dyskinetic motor response. The route of administration of a dopaminergic drug is important for the induction or prevention of motor abnormalities and adaptive gene expressions. The decline of neurotrophin-3 expression under pulsatile administration was considered of particular importance.

Therapeutic drug monitoring in child and adolescent psychiatry.

Psychopharmacotherapy in children and adolescents is characterized by an increased susceptibility for adverse events and an increased risk of ineffective treatment due to specific age-dependent and developmental characteristics in comparison to adults. Dosing in paediatric psychiatric patients requires careful handling, since the dose recommendations for adults can not simply be extrapolated to minors because of pharmacokinetic and pharmacodynamic differences. In addition, psychopharmacotherapy in children and adolescents is hampered by lack of high quality evidence on efficacy and safety in many indications and subsequently a high degree of off-label use. Therapeutic Drug Monitoring (TDM) is an established and useful tool in psychiatry to individualize and optimize the outcomes (efficacy/safety balance) of psychopharmacological drug treatment in the individual patient by dose adjustments based upon measured serum concentrations. In children and adolescents the administration of psychotropic drugs is a general indication for performing TDM. However, TDM studies specific in these age groups are necessary to identify age and indication specific therapeutic ranges of serum concentrations. Systematic collection of data on drug exposure, serum concentrations and clinical characteristics as well as outcomes can generate such practice-based evidence. A German-Swiss-Austrian competence network for TDM in child and adolescent psychiatry using a multi-centre internet-based data infrastructure was founded to document and collect demographic, safety and efficacy data as well as blood concentrations of psychotropic drugs in children and adolescents (further information: www.tdm-kjp.com).

AGNP consensus guidelines for therapeutic drug monitoring in psychiatry: update 2011.

Therapeutic drug monitoring (TDM), i. e., the quantification of serum or plasma concentrations of medications for dose optimization, has proven a valuable tool for the patient-matched psychopharmacotherapy. Uncertain drug adherence, suboptimal tolerability, non-response at therapeutic doses, or pharmacokinetic drug-drug interactions are typical situations when measurement of medication concentrations is helpful. Patient populations that may predominantly benefit from TDM in psychiatry are children, pregnant women, elderly patients, individuals with intelligence disabilities, forensic patients, patients with known or suspected genetically determined pharmacokinetic abnormalities or individuals with pharmacokinetically relevant comorbidities. However, the potential benefits of TDM for optimization of pharmacotherapy can only be obtained if the method is adequately integrated into the clinical treatment process. To promote an appropriate use of TDM, the TDM expert group of the Arbeitsgemeinschaft für Neuropsychopharmakologie und Pharmakopsychiatrie (AGNP) issued guidelines for TDM in psychiatry in 2004. Since then, knowledge has advanced significantly, and new psychopharmacologic agents have been introduced that are also candidates for TDM. Therefore the TDM consensus guidelines were updated and extended to 128 neuropsychiatric drugs. 4 levels of recommendation for using TDM were defined ranging from "strongly recommended" to "potentially useful". Evidence-based "therapeutic reference ranges" and "dose related reference ranges" were elaborated after an extensive literature search and a structured internal review process. A "laboratory alert level" was introduced, i. e., a plasma level at or above which the laboratory should immediately inform the treating physician. Supportive information such as cytochrome P450 substrate and inhibitor properties of medications, normal ranges of ratios of concentrations of drug metabolite to parent drug and recommendations for the interpretative services are given. Recommendations when to combine TDM with pharmacogenetic tests are also provided. Following the guidelines will help to improve the outcomes of psychopharmacotherapy of many patients especially in case of pharmacokinetic problems. Thereby, one should never forget that TDM is an interdisciplinary task that sometimes requires the respectful discussion of apparently discrepant data so that, ultimately, the patient can profit from such a joint eff ort.

AGNP Consensus Guidelines for Therapeutic Drug Monitoring in Psychiatry: Update 2011.

Therapeutic drug monitoring (TDM), i. e., the quantification of serum or plasma concentrations of medications for dose optimization, has proven a valuable tool for the patient-matched psychopharmacotherapy. Uncertain drug adherence, suboptimal tolerability, non-response at therapeutic doses, or pharmacokinetic drug-drug interactions are typical situations when measurement of medication concentrations is helpful. Patient populations that may predominantly benefit from TDM in psychiatry are children, pregnant women, elderly patients, individuals with intelligence disabilities, forensic patients, patients with known or suspected genetically determined pharmacokinetic abnormalities or individuals with pharmacokinetically relevant comorbidities. However, the potential benefits of TDM for optimization of pharmacotherapy can only be obtained if the method is adequately integrated into the clinical treatment process. To promote an appropriate use of TDM, the TDM expert group of the Arbeitsgemeinschaft für Neuropsychopharmakologie und Pharmakopsychiatrie (AGNP) issued guidelines for TDM in psychiatry in 2004. Since then, knowledge has advanced significantly, and new psychopharmacologic agents have been introduced that are also candidates for TDM. Therefore the TDM consensus guidelines were updated and extended to 128 neuropsychiatric drugs. 4 levels of recommendation for using TDM were defined ranging from "strongly recommended" to "potentially useful". Evidence-based "therapeutic reference ranges" and "dose related reference ranges" were elaborated after an extensive literature search and a structured internal review process. A "laboratory alert level" was introduced, i. e., a plasma level at or above which the laboratory should immediately inform the treating physician. Supportive information such as cytochrome P450 substrate- and inhibitor properties of medications, normal ranges of ratios of concentrations of drug metabolite to parent drug and recommendations for the interpretative services are given. Recommendations when to combine TDM with pharmacogenetic tests are also provided. Following the guidelines will help to improve the outcomes of psychopharmacotherapy of many patients especially in case of pharmacokinetic problems. Thereby, one should never forget that TDM is an interdisciplinary task that sometimes requires the respectful discussion of apparently discrepant data so that, ultimately, the patient can profit from such a joint effort.

[Removal of the laryngeal mask airway in the post-anesthesia care unit. A means of process optimization?]. / Geplante Entfernung der Kehlkopfmaske im Aufwachraum. Mittel zur Prozessoptimierung?

BACKGROUND: Removal of the laryngeal mask airway in the post-anesthesia care unit could potentially contribute to a faster turnover from one operation to the next. The aim of this study was, therefore, to obtain an insight into the potential time saving and the safety of planned removal of the ProSeal™-LMA (PLMA) in the post-anesthesia care unit. METHODS: In this study 120 adult patients with American Society of Anesthesiologists (ASA) classification I-II, age range 18-85 years, undergoing a surgical procedure under general anesthesia in which the PLMA was used were randomly assigned to one of two groups. In group I, the PLMA was removed in the awake patient in the operating room close to the end of the procedure. In group II, the anesthetised but spontaneously breathing patients were moved to the recovery room and the PLMA removed when the patient was awake. The anesthesia technique was standardized [balanced, sevoflurane, fentanyl, bispectral index-guided (BIS) target value=35±5] and identical in both groups until randomization. Patients were breathing room air during transport to the recovery room. Different time intervals as well as the incidence of critical incidents were compared between groups. An oxygen saturation (S(p)O(2)) value <95% was considered a clinically relevant and S(p)O(2) values <90% as clinically critical O(2)-desaturation. RESULTS: Removal of the PLMA took place after an average of 4.9±5.1 min in group I and after 19.5±9.6 min in group II. There was no difference in the availability of the anesthetist in the operating room for the following procedure between groups (group I: 12±5.6 min vs. group II: 10.7±4.2 min, p>0.05) despite the fact that patients of group II left the operating room faster (4.9±3.9 min) than patients of group I (7.1±5.1 min, p<0.01). In group II patients were ready for discharge (White score=12) from the recovery room later (13.2±8.2 min) than in group I (3.6±4.8 min, p<0.01). There were no significant differences in other process related time intervals between group I and group II: duration of the operation (113.2±45.9 min vs. 105.3±42.6 min), duration of dressing (5.1±3.7 min vs. 4.6±2.8 min), duration of transport to the recovery room (3.9±1.3 min vs. 3.6±1.3 min) and information at end of surgery by the surgeon (22.5±9.3 min vs. 22.4±10.5 min). The incidence of clinically relevant as well as clinically critical O(2) desaturation at the time of recovery room arrival (S(p)O(2)≤90%) was increased in group II with 33.3% vs. 56.6% and 13.3% vs. 6.7%, p<0.01, respectively. CONCLUSION: Planned PLMA removal in the recovery room after BIS-guided balanced anesthesia did not enable the anesthetist to be available earlier for induction of anesthesia in the following patient. Hence the anesthetist could not contribute to a faster turnover of cases. Obviously, with the type of close communication between surgeon and anesthetist dictated by the study protocol (announcement of expected end of surgery by the surgeon 20 min before end of surgery) it is possible for the patient to regain consciousness within a very small time window following the end of surgery. Following this kind of protocol, postponement of removal of the LMA in the recovery room does not seem to be attractive neither from a clinical nor an economic point of view. In contrast, removal of LMA in the recovery room should be restricted to occasional cases with an abrupt end of the operation or prolonged emergence from anesthesia. The obvious risk of hypoxemia necessitates continuous O(2) application and S(p)O(2) monitoring during transport to the recovery room.

[ProSeal™laryngeal mask in normal weight and obese patients : oxygenation under pressure-controlled ventilation and different end-expiratory pressures]. / ProSeal®-Kehlkopfmaske in normalgewichtigen und adipösen Patienten : Oxygenierung unter druckkontrollierter Beatmung mit verschiedenen endexspiratorischen Drücken.

BACKGROUND: Most of the data on combining pressure-controlled ventilation (PCV) with positive end-expiratory pressure (PEEP) come from studies with an endotracheal tube (ETT) whereas data on utilization of PEEP with a laryngeal mask airway (LMA) are limited. The LMA-ProSeal® (PLMA) forms a more effective seal of the airway than the LMA-Classic™ (CLMA). The application of PEEP when PCV is used with the PLMA could have an impact on oxygenation in adult patients. METHODS: For this study 148 patients with an mean age of 44 years (range18-65 years) and mean weight of 86 kg (range 49-120 kg) were recruited in 2 groups: group N ((Normal)): body-mass index (BMI) <30 kg/m(2) and group O ((Obesity)) BMI ≥30 and <36 kg/m(2). Cardiovascular and pulmonary disease and a history of smoking were exclusion criteria in addition to the usual LMA contraindications. The bispectral index-guided (BIS) anesthesia technique was used with propofol, fentanyl, and remifentanil without muscle relaxants. Measurement of PLMA seal pressure served as recruitment maneuver and PCV was randomly combined with 0 cmH(2)O, 5 cmH(2)O or 8 cmH(2)O PEEP. An arterial blood gas sample was taken 50 min after induction of anesthesia under an inspiratory oxygen fraction (F(I)O(2)) of 0.3. In the first part partial oxygen pressure (p(a)O(2)) under 0 cmH(2)O was compared with p(a)O(2) under 5 cmH(2)O and in the second part p(a)O(2) under 5 cmH(2)O was compared with p(a)O(2) under 8 cmH(2)O. A significant difference was set as p<0.025. RESULTS: The PLMA could be placed after 3 attempts in 147 patients. The mean seal pressure was in the range of 24-30 cm H(2)O. Application of randomized PEEP was possible in all patients and ventilation was comparable between corresponding groups. In group N no differences were found in part 1 (139±28 vs. 141±28 mmHg, p=0.88) or part 2 (127±24 vs. 134±26 mmHg, p=0.35). In group O there was a significant difference in p(a)O(2) in part 1 (75±12 vs. 94±18 mmHg, p=0.02) but not in part 2 (92±21 vs. 103±18 mmHg, p=0.04). CONCLUSIONS: The application of PEEP when PCV is used with the PLMA results in improved oxygenation in obese patients with a BMI ≥30 and <36 kg/m(2) but not in normal weight patients. Alveolar recruitment produced by seal pressure measurements below 30 cm H(2)O was sufficient to produce a clinically significant improvement in oxygenation in most obese patients and there was a significant improvement of oxygenation with PEEP=5 cmH(2)O. Both findings are in contrast to findings of studies using an ETT which suggests that higher pressures (40 cmH(2)O) are needed for recruitment of collapsed alveoli and higher PEEP (10 cmH(2)O) is needed to produce a clinically significant improvement in oxygenation in obese patients. The results of this study support data showing that the consequences of bronchopulmonary airway reactions known to occur with an ETT are less pronounced or absent when an LMA is used.