A randomised, controlled trial evaluating a low cost, 3D-printed bronchoscopy simulator.

Low-fidelity, simulation-based psychomotor skills training is a valuable first step in the educational approach to mastering complex procedural skills. We developed a cost-effective bronchial tree simulator based on a human thorax computed tomography scan using rapid-prototyping (3D-print) technology. This randomised, single-blind study evaluated how realistic our 3D-printed simulator would mimic human anatomy compared with commercially available bronchial tree simulators (Laerdal® Airway Management Trainer with Bronchial Tree and AirSim Advance Bronchi, Stavanger, Norway). Thirty experienced anaesthetists and respiratory physicians used a fibreoptic bronchoscope to rate each simulator on a visual analogue scale (VAS) (0 mm = completely unrealistic anatomy, 100 mm = indistinguishable from real patient) for: localisation of the right upper lobe bronchial lumen; placement of a bronchial blocker in the left main bronchus; aspiration of fluid from the right lower lobe; and overall realism. The 3D-printed simulator was rated most realistic for the localisation of the right upper lobe bronchial lumen (p = 0.002), but no differences were found in placement of a bronchial blocker or for aspiration of fluid (p = 0.792 and p = 0.057) compared with using the commercially available simulators. Overall, the 3D-printed simulator was rated most realistic (p = 0.021). Given the substantially lower costs for the 3D-printed simulator (£85 (€100/US$110) compared with > ~ £2000 (€2350/US$2590) for the commercially available simulators), our 3D-printed simulator provides an inexpensive alternative for learning bronchoscopy skills, and offers the possibility of practising procedures on patient-specific models before attempting them in clinical practice.

Ellipsometry with polarisation analysis at cryogenic temperatures inside a vacuum chamber.

In this paper we describe a new variant of null ellipsometry to determine thicknesses and optical properties of thin films on a substrate at cryogenic temperatures. In the PCSA arrangement of ellipsometry the polarizer and the compensator are placed before the substrate and the analyzer after it. Usually, in the null ellipsometry the polarizer and the analyzer are rotated to find the searched minimum in intensity. In our variant we rotate the polarizer and the compensator instead, both being placed in the incoming beam before the substrate. Therefore the polarisation analysis of the reflected beam can be realized by an analyzer at fixed orientation. We developed this method for investigations of thin cryogenic films inside a vacuum chamber where the analyzer and detector had to be placed inside the cold shield at a temperature of T ≈ 90 K close to the substrate. All other optical components were installed at the incoming beam line outside the vacuum chamber, including all components which need to be rotated during the measurements. Our null ellipsometry variant has been tested with condensed krypton films on a highly oriented pyrolytic graphite substrate (HOPG) at a temperature of T ≈ 25 K. We show that it is possible to determine the indices of refraction of condensed krypton and of the HOPG substrate as well as thickness of krypton films with reasonable accuracy.

Influenza vaccination in the elderly.

Influenza vaccination of elderly people has been shown to be useful. All vaccine types are well tolerated by higher age group vaccinees. Actually, whole virus vaccine, split virus vaccine and subunit vaccine are used in the vaccination of the elderly. Some studies have suggested that the induction of serum influenza antibody production was reduced in elderly persons when compared with that elicited in younger persons. However, investigations on the protective efficacy of influenza vaccination in the elderly have demonstrated a clinical protection of > or = 50% for preventing hospitalization. Live attenuated influenza vaccine conferred protection similar to that obtained with a conventional subunit vaccine. A virosomal unilamellar trivalent hemagglutinin vaccine showed promising serological results compared with those obtained with a whole cell vaccine and with a subunit vaccine, respectively. The actual policy is to vaccinate persons > or = 65 years of age and the groups that can transmit influenza to them. Each year's vaccine should contain three virus strains representing the influenza viruses that are likely to circulate in the upcoming winter.

[Immunogenicity and stability of an aluminum-free liposomal hepatitis A vaccine (Epaxal Berna)]. / Immunogenität und Stabilität eines aluminiumfreien liposomalen Hepatitis-A-Impfstoffs (Epaxal Berna).

The high immunogenicity of the liposomal hepatitis A vaccine (Epaxal Berna) after a single dose and after a booster dose one year later has been confirmed in several studies with healthy adult volunteers: 95-100% and 96-100% seroconversion (> or = 20 mIE/ml) after 1 and 12 months respectively, as well as a booster effect in 100% of the cases after revaccination. The tolerability of this new, alum-free vaccine has been excellent with 6-25% local and 0-13% mild systemic reactions after a dose of 0.5 ml. Stability testing with and without detergent indicated partial internalization of the hepatitis A virions in the phospholipid bilayer of the liposome vesicles with storage. Immunization of 10 healthy adult volunteers with vaccine stored for 32 months at 4 degrees C showed, however, that the duration of storage has no influence on immunogenicity and tolerability of the vaccine.

[Radiologic and ultrasound detection of gallstones]. / Radiologische und ultrasonographische Abklärung von Gallensteinen.

Ultrasonography (US) is the method of choice for evaluation of gallbladder stones with an accuracy of 96%. Number, size and calcification can be assessed by virtue of US reflection and attenuation. If more than five stones are present, the accuracy decreases. To determine the calcium content of stones more precisely, computed tomography can be used. This allows an assessment of the success rate of lithotripsy and chemolysis. Oral cholecystography is an alternative method of similar accuracy as US. It provides additional information about the patency of the cystic duct. In the presence of ductal stones, the accuracy of US decreases to 30%, mainly because of overlying bowel gas. Since 8 to 16% of all cases of cholecystolithiasis are accompanied by choledocholithiasis and since this entails a change in treatment, intravenous cholecystocholangiography with an accuracy of more than 90% is the method of choice in this case. Additionally, it provides knowledge on the biliary anatomy preoperatively. It does not, however, replace US, because opacification of the gallbladder is limited with this method. If intravenous cholecystocholangiography fails in case of impaired liver function, transcholecystic cholangiography or, in cases of dilated ducts, percutaneous transhepatic cholangiography can be used. Plain film radiography is not a suitable technique, since only 10 to 15% of all gallstones calcify.

[Spontaneous rupture of the left hepatic duct]. / Spontane Ruptur des Ductus hepaticus sinister.

A previously well 24-year-old man complained of persistent epigastric pain after a session of intensive muscle building exercise especially of the abdominal muscles. The abdomen was diffusely tender without guarding. There was an increased concentration of bilirubin (64.7 mumol/l), GOT (117 U/l), GPT (529 U/l) and alkaline phosphatase (150 U/l). Ultrasound examination showed a widening of the choledochal duct to 11 mm without signs of gallstones. Endoscopic retrograde cholangiography additionally revealed contrast-medium extravasation from the left hepatic duct. Computed tomography, performed immediately afterwards, confirmed the extravasation, while liver and pancreas were unremarkable. Laparoscopy revealed a 5 mm tear in the left hepatic duct, close to the hepatic duct bifurcation with bile effusion into the peritoneal cavity. The latter was rinsed endoscopically with Ringer's solution and drains were placed in the omental bursa and subhepatically in the region of the bile leak. To relax the sphincter Oddi glycerol trinitrate was administered postoperatively, for the first five days 72 mg/24 h intravenously, then for nine days twice daily 20 mg by month. No more bile drained as early as the second postoperative day and the patient was free of symptoms 2 weeks later.

Safety and immunogenicity of Escherichia coli O18 O-specific polysaccharide (O-PS)-toxin A and O-PS-cholera toxin conjugate vaccines in humans.

O-specific polysaccharide (O-PS) isolated from serotype 18 Escherichia coli lipopolysaccharide (LPS) was covalently coupled to either Pseudomonas aeruginosa toxin A (TA) or or cholera toxin (CT). The conjugates were nontoxic and nonpyrogenic. The conjugates were well tolerated on parenteral administration to human volunteers, with only mild, transient local reactions reported. Immunization engendered an IgG antibody response to both the O-PS and carrier protein. Anti-LPS antibody promoted the uptake and killing of an E. coli O18 strain bearing the K1 capsule by human polymorphonuclear leukocytes, which was complement dependent. Antibody to carrier protein neutralized the activity of native TA or CT in cell culture assays. Passively transferred IgG isolated from the serum of immunized donors provided a significant (P less than .01) degree of protection against fatal experimental E. coli O18 sepsis in mice. This study illustrates the potential use of such conjugates as vaccines against E. coli extraintestinal infections.

Safety and immunogenicity of a Pseudomonas aeruginosa O-polysaccharide toxin A conjugate vaccine in humans.

Lipid A-free polysaccharide (PS) isolated from Pseudomonas aeruginosa immunotype 5 lipopolysaccharide (LPS) was covalently coupled to toxin A via reductive amination. The PS-toxin A conjugate was comprised of 29.8% PS and 70.2% toxin A, possessed a molecular weight of greater than 1 X 10(6), was nontoxic for animals and was nonpyrogenic for rabbits at a dose of 50 micrograms/kg body wt when administered intravenously. The conjugate evoked only mild, transient reactions upon subcutaneous administration to human volunteers. Vaccination engendered immunoglobulin G (IgG) antibody, which neutralized the cytotoxic effect of toxin A and promoted the uptake and killing of P. aeruginosa in the presence of human polymorphonuclear leukocytes. Passively transferred IgG isolated from the serum of immunized donors was far more effective at preventing fatal P. aeruginosa burn wound sepsis than paired preimmunization serum. These studies establish the potential usefulness of such a PS-toxin A conjugate as a vaccine against P. aeruginosa.

Human rabies immunoglobulin assayed by the rapid fluorescent focus inhibition test suppresses active rabies immunization.

The rabies antibody content of each of ten lots of human rabies immunoglobulin was titrated by both the mouse neutralization test and the rapid fluorescent focus inhibition test. The two tests did not give comparable results, the antibody titres obtained by the mouse neutralization test being 1.4-9.6 times higher than those obtained by the rapid fluorescent focus inhibition test. This titre difference was associated with a consistently lower antibody response in human volunteers who had received post-exposure rabies vaccine treatment which included the administration of RIG assayed by the RFFIT.

Hyperbaric indices (HBI) assess the extent and timing of deviant blood pressure in patients under treatment.

Fourteen patients provided data from ambulatory monitoring at 7.5-min intervals for 24h. Rhythm characteristics and measures of blood pressure excess (hyperbaric indices along the 24-h scale) are presented in mmHg/h. A 10-year projection of blood pressure excess exceeded the 1,000,000 mmHg/h limit for systolic blood pressure in 4 cases and for diastolic blood pressure in 1 case. In such cases, additional treatment is urgently indicated, whether or not the mean blood pressure is near or even below the limits indicated by current guidelines.

Absence of myelin basic protein in an improved purified duck embryo rabies vaccine.

The encephalitogenic potential of rabies vaccines prepared from nervous tissue is a result of the presence of myelin basic protein. Vaccines prepared from duck embryos are economical and efficient, but, occasionally, cases of allergic encephalomyelitis have been reported. An improved rabies vaccine has been developed that contains the classical Pitman Moore strain of rabies virus grown in embryonated duck eggs. This vaccine has been highly purified and enriched in immunologically effective rabies virus glycoprotein antigen. We have searched for the presence of myelin basic protein using sensitive radioimmunological and immunoblotting techniques. Whereas the classical duck embryo rabies vaccine contained small amounts of myelin basic protein, in the improved purified duck embryo rabies vaccine, none could be detected.

[Tolerability and pharmacokinetics of an intravenous immunoglobulin preparation in immunologically normal subjects and tolerability in patients with hypogammaglobulinemia resulting from chronic lymphatic leukemia]. / Verträglichkeit und Verweildauer eines intravenösen Immunglobulinpräparates bei immunologisch gesunden Personen und Verträglichkeit bei Patienten mit Hypogammaglobulinämie infolge chronischer lymphatischer Leukämie.

Tolerance, clinical effects and kinetics of an unmodified immunoglobulin preparation for intravenous use were investigated in 4 patients with advanced chronic lymphocytic leukemia. Previously, good tolerance of the preparation had been found in 49 immunologically normal patients. The four patients with secondary humoral immunodeficiency received doses of 140-360 mg IgG/kg per infusion as outpatients at monthly intervals. With one exception, no acute infections (pneumonitis), as commonly seen before, were observed during the observation time of 24 to 68 weeks, and the pre-existing chronic infections (bronchitis, sinusitis etc.) remained compensated without antibiotics. In all four patients tolerance of the preparation was good. In all cases of hypogammaglobulinemia a dose-dependent increase in the serum IgG concentration was observed immediately after the infusion. However, persistence of the serum IgG increase showed considerable interindividual differences. The half life of the tetanus and HBs antibodies (21.7 to 34.4 and 19.7 to 25.7 days respectively) found in 4 healthy volunteers is within the biological range. This indicates an unmodified structure of the antibodies of the IgG class contained in the preparation used.

Evaluation of a combined vaccine against measles-mumps-rubella produced on human diploid cells.

The combined Measles-Mumps-Rubella vaccines commercially available for use are safe, highly immunogenic, and protective. But the acceptance rate of these vaccines by the public and also by the general practitioners in most part of Europe is not a very high one. One of the reasons for this low acceptance-rate is the fear of side-reactions. In spite of that only exceptional cases of dangerous allergic reactions induced by such vaccines, especially the lay population can be scared by the contraindications mentioned in the "physician circular-patent product information". Therefore it was worthwhile to test a new trivalent vaccine produced exclusively on human tissue without using any avian protein or animal protein extracts or antibiotics. Under double-blind conditions 120 children aged between 15 and 24 months received either the new vaccine or the commercially available M-M-R-II vaccine produced by MSD. Measles and Rubella antibodies were tested by hemagglutination-inhibition tests, Mumps by the immuno-fluorescence technique. No reports of major side-effects were received from the 12 physicians participating in the trial. The seroconversion rates recorded 6 to 8 weeks after vaccination were high (95-100%) and there was no statistically significant difference between the two vaccines with regard to immunogenic potency.

Rubini, a new live attenuated mumps vaccine virus strain for human diploid cells.

A new, live attenuated mumps vaccine virus strain for human diploid cells has been developed at the Swiss Serum and Vaccine Institute, Berne. The Rubini virus was derived from a child of the same name possessing typical clinical signs and symptoms of mumps infection. Attenuation of the wild virus was performed by isolation and serial passage in WI-38 human diploid cells, specific pathogen-free hens' eggs and MRC-5 human diploid cells. The attenuated virus has been examined in respect of identity, freedom from adventitious agents and growth potential in MRC-5 cells. Furthermore, it does not evoke any clinical reactions in either baby or adult monkeys. It is characterized by the production in Vero cells of smaller plaques than are elicited by either the Jeryl Lynn or Urabe mumps virus strains. The reactogenicity and immunogenicity of the Rubini virus for man was studied by administering a monovalent vaccine to 13 adult male volunteers and a trivalent human diploid cell Rubini, measles (Edmonston-Zagreb-19 virus strain) and rubella (RA 27/3 virus strain) vaccine to 60 children ranging in age from 15 to 24 months. No reactions were observed. Seroconversion was obtained in 95% of the vaccinees, who developed a mean 50% neutralizing antibody titre of 1:64 after 6-8 weeks. Sensitization to avian and other animal proteins and antibiotics which may follow the use of most of the currently available measles-mumps-rubella vaccines, either single or combined, may be expected to be eliminated when this new vaccine is used. Its use in persons already sensitized to such products should furthermore induce no anaphylactic reactions.