Prevalence of post-traumatic stress disorder, depression and somatisation in recently arrived refugees in Germany: an epidemiological study.

AIMS: Despite recent worldwide migratory movements, there are only a few studies available that report robust epidemiological data on the mental health in recent refugee populations. In the present study, post-traumatic stress disorder (PTSD), depression and somatisation were assessed using an epidemiological approach in refugees who have recently arrived in Germany from different countries. METHODS: The study was conducted in a reception facility for asylum-seekers in Leipzig, Germany. A total of 1316 adult individuals arrived at the facility during the survey period (May 2017-June 2018), 569 of whom took part in the study (N = 67 pilot study and N = 502 study sample; response rate 43.2%). The questionnaire (11 different languages) included sociodemographic and flight-related questions as well as standardised instruments for assessing PTSD (PCL-5), depression (PHQ-9) and somatisation (SSS-8). Unweighted and weighted prevalence rates of PTSD, depression and somatisation were presented stratified by sex and age groups. RESULTS: According to established cut-off scores, 49.7% of the respondents screened positive for at least one of the mental disorders investigated, with 31% suffering from somatisation, 21.7% from depression and 34.9% from PTSD; prevalence rates of major depression, other depressive syndromes and PTSD were calculated according to the DSM-5, which indicated rates of 10.3, 17.6 and 28.2%, respectively. CONCLUSIONS: The findings underline the dramatic mental health burden present among refugees and provide important information for health care planning. They also provide important information for health care systems and political authorities in receiving countries and strongly indicate the necessity of establishing early psychosocial support for refugees suffering from psychological distress.

Nasal vs oral intubation.

Both nasal and oral route for intubation have advantages and disadvantages. Oral intubation is easier to perform, faster and less painful than nasal intubation under direct laryngoscopy, while blind nasal intubation represents a good alternative in conscious patient, without sedation. In trauma patient, oral route should be preferred, with cervical immobilisation. By the contrary, nasal intubation can cause bleeding, retro-pharyngeal and turbinate bones injury, but it seems preferable in preventing laryngeal complications. Moreover nasal intubation seem to increase risk for sinusitis while, there is no clear advantage for any of the two routes, concerning nosocomial pneumonia, bacteriemia and otitis. Nevertheless nasal route increases comfort for the patient and decreases injury and necrosis of tongue and lips; tube fastening is simpler thus reducing accidental extubation.

[Selective activation of blood pressure monitoring alarms: effect of noise pollution in the intensive care unit]. / Activation sélective des alarmes sur le monitoring de la pression artérielle: effet sur la pollution sonore en réanimation.

OBJECTIVE: To evaluate a selective activation of sounding alarms on non-invasive blood pressure (BP) monitoring according to the patient haemodynamic status. STUDY DESIGN: Prospective study. METHODS: Activation of alarms on BP was regulated with a protocol. Sounding alarms were either inactivated when patient's haemodynamic status was stable (group 1), or activated when it was unstable (group 2). The frequency of BP measurement was one every 15 min. For all mean BP value recorded, the following criteria were analyzed: 1) normality of the value compared to ranges 65-115 mmHg in group 1 or compared to alarm thresholds in group 2; 2) consequences on the care and therapeutic; 3) delay when an abnormal value was detected and managed after more than 15 min. RESULTS: 1,674 hours of monitoring from 42 patients, allowed the analysis of 6,695 measurements of mean BP, 3,092 in group 1 and 3,603 in group 2. In group 1, 2,822 measurements were considered as normal and 3,094 measures in group 2. Eight measurements had consequences on therapeutic in group 1, with only one with delay in care giving. 287 measurements had consequences on therapeutic in group 2, 8 with delay in care giving. Six per cent of abnormal measurements in group 2 were managed with delay. This protocol reduced by 52% the production of sounding alarms on BP, without noxious effects for the patients. CONCLUSION: Selective activation of sounding alarms on BP, according to the patient haemodynamic status, reduced noise pollution and could be one solution to improve monitoring efficiency in intensive care unit.

Phase II clinical trial of sipatrigine (619C89) by continuous infusion in acute stroke.

BACKGROUND: The sodium channel blocker sipatrigine (619C89) prevents ischemia-induced glutamate release and is neuroprotective in animal models of stroke. Previous clinical experience found neuropsychiatric effects attributed to sipatrigine that may have been related to peak plasma concentrations of the drug. METHODS: Patients within 12 h of clinically diagnosed stroke were randomized to placebo or sipatrigine at total doses of 10, 18, 27, or 36 mg/kg by continuous intravenous infusion over 65 h. Pharmacokinetic and routine laboratory analyses were undertaken. The outcome at 30 days or 3 months was assessed by Barthel and Rankin scores. RESULTS: Twenty-seven patients were recruited: 7 of 21 patients stopped the sipatrigine infusion early due to adverse events as compared with none of 6 placebo patients. Neuropsychiatric effects (reduced consciousness, agitation, confusion, visual perceptual disturbance, or frank hallucinations) occurred in 16 of 21 patients receiving sipatrigine and in no placebo patients. Nausea, vomiting, infusion site reactions, and hyponatremia were also commoner in sipatrigine patients. Pharmacokinetic parameters were similar to those observed previously. No effects on outcome measures were demonstrated. CONCLUSIONS: Continuous infusion of sipatrigine is associated with neuropsychiatric effects. No difference in the nature of these events was evident between this regimen and repeated short infusions, but it was possible to administer higher doses.

Nadroparin in the prevention of deep vein thrombosis in acute decompensated COPD. The Association of Non-University Affiliated Intensive Care Specialist Physicians of France.

Low molecular weight heparins are as effective as unfractionated heparin in deep-vein thrombosis (DVT) prophylaxis for major surgery. However, there is no evidence nor consensus for prophylaxis in medical patients. We compared the efficacy and safety of nadroparin calcium (nadroparin) with placebo in medical patients at high risk of DVT. A total of 223 patients mechanically ventilated for acute, decompensated chronic obstructive pulmonary disease, were randomized to treatment with subcutaneous nadroparin adjusted for body weight (0.4 ml, i.e., 3,800 AXa IU, or 0.6 ml, i.e., 5,700 AXa IU) or placebo. The average duration of treatment was 11 d. The incidence of DVT in patients receiving nadroparin was significantly lower than that in patients receiving placebo (15.5 versus 28.2%; p = 0.045). Although the incidence of adverse events was high in both groups, there were no significant differences between nadroparin and placebo for total adverse events (46.3 versus 39.8%; p = 0.33), serious adverse events (25.0 versus 19.5%; p = 0.32), or those resulting in early permanent discontinuation of treatment (12.0 versus 8.8%; p = 0.44). The most common adverse event was hemorrhage. There was the same number of deaths in both treatment groups. Subcutaneous nadroparin resulted in 45% decrease in incidence of DVT compared with placebo.

[Phare study. Comparative study of combined cefepime-amikacin versus ceftazidime combined with amikacin in the treatment of nosocomial pneumonias in ventilated patients. Multicenter group study]. / Etude phare. Etude comparative de l'association céfépime-amikacine versus ceftazidime en association avec l'amikacine dans le traitement des pneumonies nosocomiales chez les patients ventilés. Le groupe multicentrique de l'étude.

OBJECTIVE: To compare the associations of cefepime (2 g x 2/day) + amikacin (7.5 mg.kg-1 x 2/day) (= cefe-ami) and ceftazidime (2 g x 3/day) + amikacin (7.5 mg.kg-1 x 2/day) (= cefta-ami) in patients under mechanical ventilation suffering from a nosocomial pneumonia. STUDY DESIGN: Multi-centre, open, comparative, randomised study. PATIENTS: The study included 275 ICU patients enrolled either in the cefe-ami group (n = 141) or in the cefta-ami group (n = 134). METHODS: All cases were reviewed in a blinded fashion by the steering committee. RESULTS: Microbiology laboratory tests were positive in 74% of patients of the cefe-ami group and in 63% of the cefta-ami group respectively; 319 presumed causative strains of bacteria were isolated. The mean duration of treatment was 12 days for cefepime, 11 days for ceftazidime and 8 days for amikacin. In intention to treat, the clinical recovery rate was 48.2% in the cefe-ami group and 44.8% in the cefta-ami group respectively. In the population with a documented pneumonia, the clinical recovery was significantly better in the cefe-ami group (53.3%), than in the cefta-ami group (39.3%) (P = 0.05). In per protocol analysis, these rates reached 67.7% in the cefe-ami group and 68.2% in the cefta-ami group respectively. In the bacteriologically documented cases the eradication rates were 86.5% and 89.3% respectively. CONCLUSION: The efficacy rates of cefe-ami and cefta-ami combinations were similar in ICU patients under mechanical ventilation with a nosocomial pneumonia. However the cefe-ami association was significantly more efficient in the population with a bacteriologically documented pneumonia.

A randomized study assessing the systematic search for maxillary sinusitis in nasotracheally mechanically ventilated patients. Influence of nosocomial maxillary sinusitis on the occurrence of ventilator-associated pneumonia.

The objective of this randomized study was to compare the occurrence of nosocomial pneumonia in nasotracheally intubated patients who were randomly allocated either to a systematic search of sinusitis by CT scan (study group) or not (control group). A total of 399 patients were included: 272 male and 127 female; mean age, 61 +/- 17 yr; SAPS: 12.6 +/- 4.9. The study group consisted of 199 patients and the control group consisted of 200. In the study group, sinus CT scans were performed in case of fever at Days 4 and 8 and then every 7 d. Nosocomial sinusitis was defined as follows: fever of >/= 38 degrees C, radiographic (sinusal air-fluid level or opacification on CT scan) signs, and presence of purulent aspirate from the involved sinus puncture with >/= 10(3) cfu/ml. Patients with sinusitis received sinus lavage and intravenously administered antibiotics. In the study group, 80 patients experienced nosocomial sinusitis. In the control group, no patient was treated for a sinusitis. Ventilator-associated bronchopneumonia (VAP) was observed in 88 patients: 37 in the study group (1 mo Kaplan-Meier estimate, 34%) versus 51 in the control group (1 mo Kaplan-Meier estimate, 47%); (p = 0.02, log-rank test; relative risk [RR] = 0.61; 95% confidence interval [CI], 0.40 to 0.93). Two months overall mortality was estimated at 36% in the study group versus 46% in the control group (p = 0.03, log-rank test; RR = 0.71; 95% CI, 0.52 to 0.97). We conclude that the occurrence of VAP in patients undergoing prolonged mechanical ventilation via a nasotracheal intubation can be prevented by the systematic search and treatment of nosocomial sinusitis. The effect on mortality should be confirmed.

Microbiological evaluation of infected wounds of the extremities in 214 adults.

OBJECTIVE: The aim of this multicentre prospective study was to analyse microbial pathogens cultured from an infected wound. METHODS: The study was performed in the emergency rooms of 10 public hospitals. All adult patients with a clinical diagnosis of cellulitis after a wound in the upper or lower extremities were included. Cultures were obtained with swabs from infected lesions. Micro-organisms cultured were identified by the usual methods and susceptibility testing was performed. RESULTS: The study population consisted of 214 patients, 153 men and 61 women, with a mean (SD) age of 40 (10) years. Wound cultures remained sterile in 28 cases and infected with micro-organisms in 186 cases. Of the 186 positive cultures, three were not identified. Of the 183 remaining cultures, one micro-organism was present in 132 patients (62%) and several micro-organisms in 51 patients (24%). A total of 248 micro-organisms were isolated in 183 patients. Staphylococcus and streptococcus were the most frequently isolated micro-organisms (56% and 21% respectively) followed by Gram negative bacilli (18%). Determination of the susceptibility to the antibiotics commonly used to treat wound infections showed resistance in some cases. CONCLUSION: These results support the need always to take culture specimens from infected wounds for microbiological evaluation and antibiotic susceptibility determination, so that adapted chemotherapy can be prescribed.

Confirmatory platelet-activating factor receptor antagonist trial in patients with severe gram-negative bacterial sepsis: a phase III, randomized, double-blind, placebo-controlled, multicenter trial. BN 52021 Sepsis Investigator Group.

OBJECTIVE: To determine the efficacy and safety of using natural platelet-activating factor receptor antagonist (PAFra), BN 52021, to treat patients with severe Gram-negative bacterial sepsis. DESIGN: A prospective, randomized, double-blind, placebo-controlled, multicenter clinical trial. SETTING: Fifty-nine academic medical center intensive care units in Europe. PATIENTS: Six hundred nine patients with severe sepsis, suspected to be related to Gram-negative bacterial infection, who received PAFra or placebo. INTERVENTIONS: Patients were randomized to receive either a dose of PAFra (120 mg iv) every 12 hrs over a 4-day period or placebo over a 4-day period. MEASUREMENTS AND MAIN RESULTS: The patients were well matched at study entry for severity of illness and for risk factors known to influence the outcome of sepsis. Among all randomized patients, the 28-day, all-cause mortality rate was 49% (152/308) in the placebo group, and 47% (140/300) in the PAFra group (p=.50). When analyzed on the basis of the previously defined target population, the 28-day, all-cause mortality rate was 50% (115/232) in the placebo group and 44% (94/212) in the PAFra group, yielding a 12% reduction in mortality rate (p=.29). In patients with documented infection involving other organisms, there was no difference between treated and placebo groups. When the outcomes of organ dysfunctions were examined in the overall population and in the documented Gram-negative bacterial infection population, the number of patients who resolved hepatic dysfunction tended to be higher in the treated group than in the placebo group (p=.06). The number of adverse events reported were not different between the two groups. CONCLUSIONS: A 4-day administration of the studied PAFra (BN 52021) failed to demonstrate a statistically significant reduction in the mortality rate of patients with severe sepsis suspected to be related to Gram-negative bacterial infection. If PAFra treatment has any therapeutic activity in severe Gram-negative bacterial sepsis, the incremental benefits are small and will be difficult to demonstrate in a patient population as defined by this clinical trial.

Platelet-activating factor receptor antagonist BN 52021 in the treatment of severe sepsis: a randomized, double-blind, placebo-controlled, multicenter clinical trial. BN 52021 Sepsis Study Group.

OBJECTIVE: To evaluate the safety and efficacy of a natural platelet-activating factor receptor antagonist, BN 52021 (Ginkgolide B), in the treatment of patients with sepsis syndrome. DESIGN: Prospective, randomized, placebo-controlled, double-blind, phase III, multicenter clinical trial. SETTING: Twenty-one academic medical center intensive care units in France. PATIENTS: Two hundred sixty-two patients with sepsis syndrome who received standard supportive care and antimicrobial therapy, in addition to the administration of platelet-activating factor receptor antagonist or placebo. INTERVENTIONS: Patients received either a 120-mg dose of platelet-activating factor receptor antagonist intravenously every 12 hrs over a 4-day period or placebo. MAIN OUTCOME MEASUREMENTS: All patients were evaluated for 28-day, all-cause mortality. RESULTS: The 28-day mortality rate was 51% for the placebo group and 42% for the platelet-activating factor receptor antagonist group (p = .17). However, the efficacy of platelet-activating factor receptor antagonist was significantly greater in patients with Gram-negative sepsis (test for interaction, p = .03). In a separate analysis of patients with and without Gram-negative sepsis, the 28-day mortality rate was 57% for the patients receiving placebo (30 deaths of 53 patients) and 33% for patients receiving platelet-activating factor receptor antagonist (22 deaths of 67 patients; p = .01). Platelet-activating factor receptor antagonist also significantly (p = .01) reduced the mortality rate among patients with Gram-negative sepsis who were in shock at entry into the study (mortality rate was 65% for placebo vs. 37% for platelet-activating factor receptor antagonist) and among patients > 60 yrs of age (mortality rate was 74% for placebo vs. 31% for platelet-activating factor receptor antagonist). A Cox proportional-hazards model identified five independent prognostic factors: a) adequacy of antibiotic therapy; b) severity of illness; c) renal failure; d) hematologic failure; and e) hepatic failure at study entry. When the Gram-negative sepsis population was stratified by age and these five prognostic factors were controlled for, the relative risk of death of the platelet-activating factor receptor antagonist group was 0.61 (0.34 to 1.08, 95% confidence interval; p = .09). This risk corresponds with an adjusted reduction in mortality rate of 39% for patients receiving platelet-activating factor receptor antagonist. No differences in mortality rates were found between the placebo and the platelet-activating factor receptor antagonist groups in the absence of Gram-negative sepsis. There were no differences in adverse events between the placebo and the treated groups. CONCLUSION: The studied platelet-activating factor receptor antagonist (BN 52021) seems to be a safe and promising treatment for patients with severe Gram-negative sepsis.

Influence of long-term oro- or nasotracheal intubation on nosocomial maxillary sinusitis and pneumonia: results of a prospective, randomized, clinical trial.

OBJECTIVE: To compare the occurrence rate of nosocomial maxillary sinusitis and pneumonia in patients who have undergone nasotracheal vs. orotracheal intubation. DESIGN: Randomized, clinical trial. SETTING: General adult intensive care unit (ICU) in a nonteaching public hospital. PATIENTS: A total of 300 (209 male, 91 female) patients were included. The mean age was 59 +/- 17 (SD) yrs. The simplified acute physiologic score was 14 +/- 6. Reasons for admission to the ICU were: coma (n = 78), pneumonia (n = 46), infection (n = 35), surgery (n = 34), multiple trauma (n = 20), head trauma (n = 12), other (n = 75). Among the 300 patients, 149 were randomized into the nasotracheal group and 151 into the orotracheal group. No statistical difference was found between initial characteristics of the two groups. INTERVENTIONS: Patients were randomized between nasal and oral endotracheal intubation. Gastric intubation was performed via the same route as endotracheal intubation. Sinus computed tomography (CT) scans were performed every 7 days or earlier in case of fever and/or purulent nasal discharge. Criteria for nosocomial sinusitis were as follows: fever of > 38 degrees C, radiographic (sinusal air-fluid level or opacification on CT scan) signs and presence of purulent aspirate from the involved sinus puncture with 10(3) colony-forming units (cfu)/mL. Diagnosis of pneumonia was based on classical criteria and a protected brush specimen with 10(3) cfu/mL. MEASUREMENTS AND MAIN RESULTS: Radiographic evidence of sinusitis was observed in 78 patients, 45 from the nasal group and 33 from the oral group (p = .08, log-rank test). Among these patients, 54 fulfilled the sinusitis criteria stated above, 29 in the nasal group and 25 in the oral group (p = .75, log-rank test). Nosocomial pneumonia was observed in 26 patients, 17 in the nasal group and 9 in the oral group (p = .11, log-rank test). A multivariable analysis considering sinusitis as a time-dependent factor has suggested that sinusitis increased the risk of nosocomial pneumonia by a factor of 3.8. Nosocomial septicemia was observed in 33 patients, 22 episodes in the nasal group and 13 episodes in the oral group (p = .11, log-rank test). Overall mortality rate was 37% in the nasal group vs. 41% in the oral group (p = .37, log-rank test). Episodes of atelectasis and accidental extubations, and doses of sedative drugs and antibiotics were not different between the two groups. Length of mechanical ventilation did not differ between the two intubation groups. The mean length of stay in the ICU was 11 +/- 15 days in the nasal group vs. 9.5 +/- 11 days in the oral group (p = .27, Student's t-test). CONCLUSIONS: In patients undergoing prolonged mechanical ventilation, there was no statistically significant difference in the occurrence rate of nosocomial sinusitis or pneumonia between patients undergoing tracheal intubation via the nasal vs. oral route. A trend (p = 0.008) suggests less sinusitis in the orotracheal group.

[Diffusion of amikacin into the sinuses in patients with nosocomial sinusitis. Administration of a single dose per day]. / Diffusion de l'amikacine dans les sinus chez les malades ayant une sinusite nosocomiale. Administration en dose unique journalière.

Twenty mechanically ventilated patients with nosocomial sinusitis were treated with amikacin 15 mg/kg administered either once a day (group 1 patients) or twice a day (group 2 patients). Amikacin was assayed in serum and in the liquid drained from the sinuses 8 times over a 24 hours' period (group 1) or 7 times over a 12 hours' period (group 2). The amikacin concentration peak was 10.9 mg/l in group 1 and 5.1 mg/l in group 2. It is concluded that amikacin can be used to treat patients with nosocomial sinusitis. High amikacin concentrations are reached with the once a day dosage.

[Diffusion of piperacillin into the sinuses of patients with nosocomial sinusitis]. / Diffusion de la pipéracilline dans les sinus chez les malades atteints de sinusite nosocomiale.

Six mechanically ventilated patients with nosocomial sinusitis received an intravenous infusion of 4 g of piperacillin. Piperacillin concentrations were measured in the serum and in drained sinusal fluid 1, 2, 3, 4, 6 and 8 hours after the beginning of the infusion. A peak piperacillin level of 33 mg/l was obtained 30 minutes after the end of administration, and concentrations of 14 mg/l or more persisted for up to 8 hours. It is concluded that piperacillin can be used to treat patients with nosocomial sinusitis.

[Intracranial hypertension in comatose bacterial meningitis]. / Hypertension intracrânienne des méningites bactériennes comateuses.

The intracranial pressure of 31 patients with bacterial meningitis, in a comatose state and with a score lower than 6 on Glasgow's scale, was monitored by means of an extradural captor in order to detect intracranial hypertension and optimize its treatment. All patients had intracranial hypertension during the first 48 hours. Brain perfusion pressure was inferior to 50 mmHg in 5 cases. Computed tomography of the brain showed cerebral oedema in 16 cases. Twenty (64%) of the patient survived, 15 of them without sequelae. Monitoring intracranial pressure in patients with bacterial meningitis and coma makes it possible to optimize treatment and shows that a less than 50 mmHg brain perfusion pressure is associated with a 100% death rate.

Comparison of high-frequency jet ventilation to conventional ventilation in adults with respiratory distress syndrome.

Sixteen patients with acute respiratory failure (ARF) were studied. In group I (12 patients, 15 explorations) patients were treated with continuous positive pressure ventilation (CPPV) during conventional ventilation (CV), pulmonary lesions (PL) were severe (Qsp/Qt = 0.24 +/- 0.16 with PEEP = 14 +/- 7 cm H2O) and high-frequency jet ventilation (HFJV) was performed without spontaneous ventilation (SV). In group II (5 patients, 12 explorations) patients were treated with intermittent mandatory ventilation (IMV) during CV, PL were moderate (Qsp/Qt = 0.13 +/- 0.05 with PEEP = 8 +/- 3 cm H2O) and HFJV was performed with SV. In both groups, frequency was 120 c/mn and I:E ratio = 1:2. The cannula size, the driving pressure and the PEEP (water column) were progressively adapted to obtain the same blood gases as those observed during CV, FIO2 being the same. Results on HFJV were compared to CV. In both groups there were no differences between PaCO2, PaO2, FIO2, Qsp/Qt during CV and HFJV. In group I peak airway pressure (PAWP), mean artery pressure (MAP), heart rate (HR), transmural mean pulmonary and wedge pressure (MPAPtm, PWPtm) were not different. Mean airway pressure (MAWP), PEEP and pleural pressure (PP) were higher, cardiac index (CI) was lower. In group II, PP, CI, MAP, HR, MPAPtm, MPWPtm were not different. PAWP was lower, MAWP and PEEP were higher. We conclude that during HFJV it is possible to obtain the same blood gas as during CV, but HFJV without CV may not be indicated in patients with severe PL, because circulatory impairment is higher.

Metastatic interstitial pneumonitis after autologous bone marrow transplantation. A consequence of reinjection of malignant cells?

Two cases of fatal interstitial pneumonitis developing after an autologous bone marrow transplantation are described. In both cases the autopsy revealed diffuse malignant pulmonary involvement. The first case involved a 4-year-old boy who had a Burkitt's lymphoma; the second case involved a 4-year-old girl with a neuroblastoma. The authors postulate that in these cases, the clinical picture may have been related to reinfusion of malignant cells.