102 research outputs found
The European Union Directive on Clinical Research: present status of implementation in EU member states’ legislations with regard to the incompetent patient
No full textpeer reviewedA European-wide response is slowly emerging to the European Union Directive on Clinical Research (2001/20/CE) establishing good practice in the conduct of clinical trials on medicinal products [1]. The Directive was to have been incorporated and made effective in member states’
national laws by 1 May 2004. Among many other aspects of this wide-ranging Directive passed by the European Parliament on 4 April 2001 is the requirement for prior informed consent by a legal representative for research involving incompetent patients. A preliminary survey conducted
by this group in 2002 demonstrated that many states did not possess clear definitions
for a legal representative in matters of health, and in the absence of a waiver of informed consent none could validly recruit patients to clinical trials in emergency situations. The Directive therefore had the potential to make clinical research very difficult in intensive care, and impossible in emergency situations such as cardiopulmonary resuscitation. We now report current
progress among member states in implementing the Directive
Ten-Year Experiences with Tracheostomy at a University Teaching Hospital in Northwestern Tanzania: A Retrospective Review of 214 cases.
No full textTracheostomy remains a very important life saving surgical procedure worldwide and particularly in our environment where patients present late in upper airway obstruction. Little work has been done on this subject in our environment and therefore it was necessary to conduct this study to describe our own experiences with tracheostomy, outlining the common indications and outcome of tracheostomized patients in our setting and compare our results with those from other centers in the world. This was a 10-year retrospective study which was conducted at Bugando Medical Centre from January 2001 to December 2010. Data were retrieved from patients' files kept in the Medical record department and analyzed using SPSS computer software version 15.0. Ethical approval to conduct the study was obtained from relevant authority before the commencement of the study. A total of 214 patients were studied. The male to female ratio was 3.1: 1. The majority of patients were in the 3rd decade of life. The most common indication for tracheostomy was upper airway obstruction secondary to traumatic causes in 55.1% of patients, followed by upper airway obstruction due to neoplastic causes in 39.3% of cases. The majority of tracheostomies (80.4%) were performed as an emergency. Transverse skin crease incision was employed in all the cases. Post-tracheostomy complication rate was 21.5%. Complication rate was significantly higher in emergency tracheostomy than in electives (P < 0.001). The duration of temporary tracheostomy ranged from 8 days to 46 months, with a median duration of 4 months. Tracheostomy decannulation was successively performed in 72.4% of patients who survived. Mortality rate was 13.6%. The mortality was due to their underlying illnesses, none had tracheostomy-related mortality. Upper airway obstruction secondary to trauma and laryngeal tumors still remains the most common indication for tracheostomy in our centre and tracheostomy is still a life saving procedure in the surgical management of airway despite complications which are seen more commonly in paediatric patients. Most of tracheostomy related complications can be avoided by meticulous attention to the details of the technique and postoperative tracheostomy care by skilled and trained staff
Evolution of mechanical ventilation in response to clinical research.
No full textRATIONALE:
Recent literature in mechanical ventilation includes strong evidence from randomized trials. Little information is available regarding the influence of these trials on usual clinical practice.
OBJECTIVES:
To describe current mechanical ventilation practices and to assess the influence of interval randomized trials when compared with findings from a 1998 cohort.
METHODS:
A prospective international observational cohort study, with a nested comparative study performed in 349 intensive care units in 23 countries. We enrolled 4,968 consecutive patients receiving mechanical ventilation over a 1-month period. We recorded demographics and daily data related to mechanical ventilation for the duration of ventilation. We systematically reviewed the literature and developed 11 practice-change hypotheses for the comparative cohort study before seeing these results. In assessing practice changes, we only compared data from the 107 intensive care units (1,675 patients) that also participated in the 1998 cohort (1,383 patients).
MEASUREMENTS AND MAIN RESULTS:
In 2004 compared with 1998, the use of noninvasive ventilation increased (11.1 vs. 4.4%, P < 0.001). Among patients with acute respiratory distress syndrome, tidal volumes decreased (7.4 vs. 9.1 ml/kg, P < 0.001) and positive end-expiratory pressure levels increased slightly (8.7 vs. 7.7 cm H(2)O, P = 0.02). More patients were successfully extubated after their first attempt of spontaneous breathing (77 vs. 62%, P < 0.001). Use of synchronized intermittent mandatory ventilation fell dramatically (1.6 vs. 11%, P < 0.001). Observations confirmed 10 of our 11 practice-change hypotheses.
CONCLUSIONS:
The strong concordance of predicted and observed practice changes suggests that randomized trial results have advanced mechanical ventilation practices internationally
The Impact of Temperature and Concentration on SC2 Cost and Performance in a production Environment
No full textABSTRACTRecent studies have shown that extremely dilute HCl mixtures can offer
considerable cost savings and improved particle performance relative to
traditional SC2 formulations. This work indicates, however, that extreme
levels of dilution are not necessary to secure many of the benefits
suggested for dilute HCI. Significant benefit can be attained by pursuing
moderate concentration and temperature alterations. In this study, an
intermediate dilution and temperature reduction are evaluated to assess
potential production advantage. Comparison of a 1:1:20 formulation at 60 C
is made to a more traditional 1:1:6 mixture at 85 C. The impact of the
chemistry and temperature alteration on peroxide decomposition rate is shown
to be dramatic. While initial pour-up ratios suggest that the dilute recipe
could require 1/3 as much peroxide as the traditional chemistry, chemical
savings are significantly more dramatic due to the ability of the solution
to maintain concentration over time. An additional benefit associated with
the alternative pour-up is a marked reduction in particle levels on silicon
surfaces; particle levels on thermal oxide wafers have not shown the same
trend. VPD-ICPMS measurements are used in this study to illustrate that the
recipe change results in comparable metallic removal efficiency.</jats:p
Unrecognized Left Ventricular Heart Failure Deteriorates Outcome in Mechanically Ventilated Patients with COPD.
No full textAN OBSERVATIONAL STUDY ON THE IMPACT OF THE SOCIO-ECONOMIC CRISIS IN GREECE ON ICU PATIENT RECRUITMENT
No full textComparison of two methods, the thermodilution method of Fick and the Douglas bag method, in estimating the resting energy expenditure (REE)
No full textPrediction and Outcome of Intensive Care Unit-Acquired Paresis
No full textBACKGROUND:
Intensive care unit-acquired paresis (ICUAP) is associated with poor outcomes. Our objective was to evaluate predictors for ICUAP and the short-term outcomes associated with this condition.
METHODS:
A secondary analysis of a prospective study including 4157 mechanically ventilated adults in 494 intensive care units from 39 countries. After sedative interruption, patients were screened for ICUAP daily, which was defined as the presence of symmetric and flaccid quadriparesis associated with decreased or absent deep tendon reflexes. A multinomial logistic regression was used to create a predictive model for ICUAP. Propensity score matching was used to estimate the relationship between ICUAP and short-term outcomes (ie, weaning failure and intensive care unit [ICU] mortality).
RESULTS:
Overall, 114 (3%) patients had ICUAP. Variables associated with ICUAP were duration of mechanical ventilation (relative risk ratio [RRR] per day, 1.10; 95% confidence interval [CI] 1.08-1.12), steroid therapy (RRR 1.8; 95% CI, 1.2-2.8), insulin therapy (RRR 1.8; 95% CI 1.2-2.7), sepsis (RRR 1.9; 95% CI: 1.2 to 2.9), acute renal failure (RRR 2.2; 95% CI 1.5-3.3), and hematological failure (RRR 1.9; 95% CI: 1.2-2.9). Coefficients were used to generate a weighted scoring system to predict ICUAP. ICUAP was significantly associated with both weaning failure (paired rate difference of 22.1%; 95% CI 9.8-31.6%) and ICU mortality (paired rate difference 10.5%; 95% CI 0.1-24.0%).
CONCLUSIONS:
Intensive care unit-acquired paresis is relatively uncommon but is significantly associated with weaning failure and ICU mortality. We constructed a weighted scoring system, with good discrimination, to predict ICUAP in mechanically ventilated patients at the time of awakening
International Analgesia, Sedation, and Delirium Practices: a prospective cohort study
No full textAbstract Background While understanding of critical illness and delirium continue to evolve, the impact on clinical practice is often unknown and delayed. Our purpose was to provide insight into practice changes by characterizing analgesia and sedation usage and occurrence of delirium in different years and international regions. Methods We performed a retrospective analysis of two multicenter, international, prospective cohort studies. Mechanically ventilated adults were followed for up to 28 days in 2010 and 2016. Proportion of days utilizing sedation, analgesia, and performance of a spontaneous awakening trial (SAT), and occurrence of delirium were described for each year and region and compared between years. Results A total of 14,281 patients from 6 international regions were analyzed. Proportion of days utilizing analgesia and sedation increased from 2010 to 2016 (p < 0.001 for each). Benzodiazepine use decreased in every region but remained the most common sedative in Africa, Asia, and Latin America. Performance of SATs increased overall, driven mostly by the US/Canada region (24 to 35% of days with sedation, p < 0.001). Any delirium during admission increased from 7 to 8% of patients overall and doubled in the US/Canada region (17 to 36%, p < 0.001). Conclusions Analgesia and sedation practices varied widely across international regions and significantly changed over time. Opportunities for improvement in care include increasing delirium monitoring, performing SATs, and decreasing use of sedation, particularly benzodiazepines
Multicenter International Cohort Validation of a Modified Sequential Organ Failure Assessment Score Using the Richmond Agitation-Sedation Scale
No full textOBJECTIVE: In a multicenter, international cohort, we aimed to validate a modified Sequential Organ Failure Assessment (mSOFA) using the Richmond Agitation-Sedation Scale, hypothesized as comparable to the Glasgow Coma Scale (GCS)-based Sequential Organ Failure Assessment
(SOFA).
SUMMARY BACKGROUND DATA: The SOFA score, whose neurologic component is based on the GCS, can predict ICU mortality. But, GCS is often missing in lieu of other assessments, such as the also reliable and validated RASS. Single center data suggested a RASS-based SOFA (mSOFA) predicted ICU mortality.
METHODS: Our nested cohort within the prospective 2016 Fourth International Study of Mechanical Ventilation contains 4,120 ventilated patients with daily RASS and GCS assessments (20,023 patient-days, 32 countries). We estimated GCS from RASS via a proportional odds
model without adjustment. ICU mortality logistic regression models and c-statistics were constructed using SOFA (measured GCS) and mSOFA (measured RASS-estimated GCS), adjusted for age, sex, body-mass index, region (Europe, USA-Canada, Latin America, Africa, Asia, Australia-
New Zealand), and post-operative status (medical/surgical).
RESULTS: Cohort-wide, the mean SOFA=9.4+/-2.8 and mean mSOFA=10.0+/-2.3, with ICU mortality=31%. Mean SOFA and mSOFA similarly predicted ICU mortality (SOFA: AUC=0.784, 95%CI=0.769-0.799; mSOFA: AUC=0.778, 95%CI=0.763-0.793, P=0.139). Across models, other predictors of mortality included higher age, female sex, medical patient, and African region (all P< 0.001).
CONCLUSIONS: We present the first SOFA modification with RASS in a “real-world” international cohort. Estimating GCS from RASS preserves predictive validity of SOFA to predict ICU mortality. Alternative neurologic measurements like RASS can be viably integrated into severity of illness scoring systems like SOFA
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