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1.
JAMA ; 321(22): 2175-2182, 2019 06 11.
Article in English | MEDLINE | ID: mdl-31184740

ABSTRACT

Importance: Daily spontaneous breathing trials (SBTs) are the best approach to determine whether patients are ready for disconnection from mechanical ventilation, but mode and duration of SBT remain controversial. Objective: To evaluate the effect of an SBT consisting of 30 minutes of pressure support ventilation (an approach that is less demanding for patients) vs an SBT consisting of 2 hours of T-piece ventilation (an approach that is more demanding for patients) on rates of successful extubation. Design, Setting, and Participants: Randomized clinical trial conducted from January 2016 to April 2017 among 1153 adults deemed ready for weaning after at least 24 hours of mechanical ventilation at 18 intensive care units in Spain. Follow-up ended in July 2017. Interventions: Patients were randomized to undergo a 2-hour T-piece SBT (n = 578) or a 30-minute SBT with 8-cm H2O pressure support ventilation (n = 557). Main Outcome and Measures: The primary outcome was successful extubation (remaining free of mechanical ventilation 72 hours after first SBT). Secondary outcomes were reintubation among patients extubated after SBT; intensive care unit and hospital lengths of stay; and hospital and 90-day mortality. Results: Among 1153 patients who were randomized (mean age, 62.2 [SD, 15.7] years; 428 [37.1%] women), 1018 (88.3%) completed the trial. Successful extubation occurred in 473 patients (82.3%) in the pressure support ventilation group and 428 patients (74.0%) in the T-piece group (difference, 8.2%; 95% CI, 3.4%-13.0%; P = .001). Among secondary outcomes, for the pressure support ventilation group vs the T-piece group, respectively, reintubation was 11.1% vs 11.9% (difference, -0.8%; 95% CI, -4.8% to 3.1%; P = .63), median intensive care unit length of stay was 9 days vs 10 days (mean difference, -0.3 days; 95% CI, -1.7 to 1.1 days; P = .69), median hospital length of stay was 24 days vs 24 days (mean difference, 1.3 days; 95% CI, -2.2 to 4.9 days; P = .45), hospital mortality was 10.4% vs 14.9% (difference, -4.4%; 95% CI, -8.3% to -0.6%; P = .02), and 90-day mortality was 13.2% vs 17.3% (difference, -4.1% [95% CI, -8.2% to 0.01%; P = .04]; hazard ratio, 0.74 [95% CI, 0.55-0.99]). Conclusions and Relevance: Among patients receiving mechanical ventilation, a spontaneous breathing trial consisting of 30 minutes of pressure support ventilation, compared with 2 hours of T-piece ventilation, led to significantly higher rates of successful extubation. These findings support the use of a shorter, less demanding ventilation strategy for spontaneous breathing trials. Trial Registration: ClinicalTrials.gov Identifier: NCT02620358.


Subject(s)
Intubation, Intratracheal/instrumentation , Positive-Pressure Respiration , Ventilator Weaning/methods , Adult , Aged , Female , Humans , Intensive Care Units , Male , Middle Aged , Odds Ratio , Respiration, Artificial , Standard of Care , Time Factors , Treatment Outcome
2.
PLoS One ; 14(3): e0212557, 2019.
Article in English | MEDLINE | ID: mdl-30840651

ABSTRACT

OBJECTIVE: To assess whether the psychological variables perceived stress, neuroticism and coping strategies, are associated with Premenstrual Syndrome (PMS) and Premenstrual Dysphoric Syndrome (PMDD). DESIGN: Case-control study with incident cases using the Spanish public healthcare system. SETTING: 3 major public hospitals and one family counseling and planning center. POPULATION: Women consulting for troubles related to menstruation and for other motives such as screening for uterine cancer, contraception counselling or desire for pregnancy. METHODS: Logistic regression. MAIN OUTCOME MEASURES: Odds of PMS and PMDD. RESULTS: 285 PMS and 285 age-matched controls, as well as 88 PMDD cases and 176 controls participated in the study. Medium and high levels of perceived stress were associated with an increase in the odds of PMS (Odds Ratio (OR) = 2.49; 95%CI: 1.41-4.39 and OR = 4.90; 95%CI: 2.70-8.89, respectively). For PMDD the results were: OR = 2.61; 95%CI: 1.35-5.05 and OR = 5.79; 95%CI: 2.63-12.76, respectively. Subjects with medium and high levels of neuroticism were also at higher odds of suffering from PMS (OR = 2.53; 95%CI: 1.06-6.06 and OR = 8.05; 95%CI: 3.07-2.12, respectively). For PMDD, the results were OR = 3.70; 95%CI: 1.27-10.77 and 5.73: 95%CI: 1.96-16.77, respectively. High levels in the large majority of coping strategies were also associated with increased odds of PMS and PMDD. CONCLUSIONS: Psychological factors including perceived stress, neuroticism and coping strategies are strongly related to PMS/PMDD. This association is unlikely to be due to confounding or misclassification bias. A reverse causation process cannot be ruled out although its likelihood is remote.


Subject(s)
Premenstrual Dysphoric Disorder , Stress, Psychological , Adolescent , Adult , Case-Control Studies , Female , Humans , Premenstrual Dysphoric Disorder/physiopathology , Premenstrual Dysphoric Disorder/psychology , Stress, Psychological/physiopathology , Stress, Psychological/psychology
5.
J Biomater Sci Polym Ed ; 17(6): 689-707, 2006.
Article in English | MEDLINE | ID: mdl-16892729

ABSTRACT

A polyglycerol with dendritic structure (PGLD) was synthesized by ring-opening polymerization of deprotonated glycidol using a polyglycerol as core functionality in a step-growth process. Then, PGLD reacted with O-carboxymethylated chitosan to obtain PGLD-chitosan dendrimer (PGLD-Ch). After the reaction of PGLD-Ch with boric acid, there was a marked increase in the bulk viscosity evidencing physically that boron can initiate a charge transfer complex formation, (PGLD-Ch)B. Gel permeation chromatography analysis was used to characterize the molecular weight and the polydispersivity of the synthesized PGLD-Ch. A dendritic structure with a molecular mass of 16.7 kDa and a narrow polydispersity (Mw/Mn = 1.05) was obtained. 1H-NMR and 13C-NMR measurements were employed to assess the degree of branching in PGLD. The obtained value of 0.85 indicates the tendency toward a dentritic structure for PGLD. The glass transition temperature values of (PGLD-Ch)B membranes containing 10% and 30% PGLD were -19 degrees C and -26 degrees C, respectively, which favor its potential use as surface coating of several polymers. The in vitro cytotoxicity was evaluated using the minimum essential medium elution test assay. Extracts of boron-complexed PGLD exhibited lower cytotoxicity than the controls, suggesting that the material has an improved biocompatibility. Antibacterial studies of (PGLD-Ch)B against Staphylococcus aureus and Pseudomonas aeruginosa showed a significant activity. Our study confirms and supports the effectiveness of (PGLD-Ch)B as an antimicrobial coating due to its capacity in suppressing the bacterial proliferation. The best in vivo response was found for (PGLD-Ch)B-30 membranes, which exhibited higher synthesis of collagen fibers than PGLD-ChB-10.


Subject(s)
Anti-Bacterial Agents/chemistry , Biocompatible Materials/chemistry , Boron Compounds/chemistry , Chitosan/chemistry , Glycerol/chemistry , Polymers/chemistry , Animals , Anti-Bacterial Agents/chemical synthesis , Anti-Bacterial Agents/pharmacology , Biocompatible Materials/chemical synthesis , Biocompatible Materials/pharmacology , Boron Compounds/chemical synthesis , Boron Compounds/pharmacology , CHO Cells , Chemical Phenomena , Chemistry, Physical , Chitosan/chemical synthesis , Chitosan/pharmacology , Cricetinae , Female , Glycerol/chemical synthesis , Glycerol/pharmacology , Materials Testing , Molecular Structure , Nuclear Magnetic Resonance, Biomolecular , Polymers/chemical synthesis , Polymers/pharmacology , Prostheses and Implants/adverse effects , Pseudomonas aeruginosa/drug effects , Rats , Rats, Wistar , Staphylococcus aureus/drug effects
6.
J Biomed Mater Res A ; 64(1): 147-54, 2003 Jan 01.
Article in English | MEDLINE | ID: mdl-12483707

ABSTRACT

Different poly(vinyl alcohol) (PVA)/chitosan lactate (ChL)-blended hydrogels containing nitrofurazone as a local anti-infective drug were prepared by the phase-inversion technique. The swelling degree, surface free energy, mechanical properties, and nitrofurazone release of these membranes were determined. Blood compatibility of these systems was evaluated by the open-static platelet adhesion test with whole human blood. The results showed that water absorption into the PVA/ChL membranes slowed down, governed by the rate at which the dressing interacted with the physiological fluid. Swelling degree values up to 200% were observed. The rate of release of nitrofurazone seemed to depend on the ChL percentage on the blend as well as the pH of the solution. The surface free energy values were in the range of 20-30 dynes/cm, which was appropriate for a favorable interaction with blood. From the Young's module curve, it could be seen that elastic hydrogels were obtained with increment of ChL in the PVA/ChL blends. Values of platelet adhesion and whole blood clotting times for the PVA/ChL blends as well as the increase of ChL, which appears to reduce the fibrinogen adsorption on the PVA/ChL membranes, demonstrated that the blood compatibility of PVP/ChL blends is superior to that separated polymers. The results of in vivo experiments in rats were in very good agreement with these observations, suggesting that PVA/ChL may serve as a new type of potential wound-dressing material.


Subject(s)
Bandages , Biocompatible Materials , Chitin/analogs & derivatives , Chitin/chemistry , Membranes, Artificial , Blood , Chitosan , Humans , Surface Properties
7.
Intensive Care Med ; 28(10): 1470-4, 2002 Oct.
Article in English | MEDLINE | ID: mdl-12373473

ABSTRACT

OBJECTIVE: Thermodilution (TD) is the gold standard to monitor cardiac output (CO) in critical care. However, there is concern about the safety of right-ventricular catheterization. The CO(2) rebreathing technique allows noninvasive CO determination by means of the indirect Fick principle. Our objectives were: (a) to assess the accuracy of a new system of CO measurement using the CO(2) partial rebreathing method (PRCO); (b) to evaluate whether the PRCO itself may induce changes in CO. DESIGN AND SETTING: Prospective study in the intensive care department in a university-affiliated hospital. PATIENTS: Twenty-two mechanically ventilated critically ill patients. INTERVENTIONS: CO measured simultaneously by PRCO and TDCO. MEASUREMENTS AND RESULTS: PRCO and TDCO values were compared by concordance analysis. Stability of cardiac output during PRCO was evaluated by comparing the TDCO measurements before, during, and after the partial rebreathing period using analysis of variance. From a total of 79 valid sets of measurements, bias and precision was calculated at -0.18+/-1.39 l/min. The concordance analysis of lower and intermediate CO values (<7 l/min) yielded a bias and precision calculation of -0.07+/-0.91 l/min. No changes in hemodynamics were observed during the partial rebreathing period. CONCLUSIONS: The noninvasive partial CO(2) rebreathing technique may be an alternative method for CO determination in mechanically ventilated critically ill patients. The rebreathing maneuver alone does not induce changes in CO.


Subject(s)
Cardiac Output , Critical Care/methods , Monitoring, Physiologic/methods , Respiration, Artificial , Breath Tests , Carbon Dioxide/analysis , Hospitals, University , Humans , Intensive Care Units , Prospective Studies , Spain
8.
J Biomed Mater Res ; 61(1): 66-74, 2002 Jul.
Article in English | MEDLINE | ID: mdl-12001248

ABSTRACT

Partially biodegradable acrylic composites containing poly(methyl methacrylate)-poly(epsilon-caprolactone) (PMMA/PCL) systems were prepared by mixing the corresponding PMMA/PCL beads (89:11, 86:14, 83:17, and 77:23 weight ratio) used as solid phase with methyl methacrylate (MMA) (liquid phase) in a solid/liquid ratio of 1.5:1. The physical and chemical microheterogeneity of these beads influenced significantly the curing parameters, because several aspects involved in the polymerization reaction are closely related to both morphology and size distribution of the particles. In vitro behavior was studied by immersion in simulated body fluid at pH = 7.4 and 37 degrees C for more than 8 weeks and the composition was followed by 1H-nuclear magnetic resonance spectroscopy. Approximately 2% wt/wt weight loss was observed after a period of 8 weeks for the composites richest in PCL. Mechanical properties of the dry and wet specimens were evaluated by compressive and tensile tests. In all cases, the presence of PCL in the composites provided a significant decrease in both compressive strength and elastic modulus compared with plain PMMA. Tensile and compressive strength also decreased significantly after 2 weeks of immersion in simulated body fluid compared with dry specimens. The self-curing composites based on PMMA/PCL beads and loaded with 3% wt/wt vancomycin were evaluated as carriers for local release of antibiotics. The composite prepared with beads of PMMA/PCL ratio 86:14 was the most effective. It eluted 64% of the initial drug within the first 5 h, allowing progressive release of nearly the total amount of the initial drug (90%) in approximately 2 months. The results obtained suggest that the described composites can be suitable for antibiotic release in non-load bearing graft applications.


Subject(s)
Drug Delivery Systems , Methylmethacrylate/chemistry , Polyesters/chemistry , Polymers/chemistry , Biocompatible Materials/chemistry , Humans , Magnetic Resonance Spectroscopy , Mechanics , Particle Size , Temperature , Vancomycin/metabolism
9.
Am J Respir Crit Care Med ; 165(2): 165-70, 2002 Jan 15.
Article in English | MEDLINE | ID: mdl-11790648

ABSTRACT

The objective was to analyze the physiologic effects of recruitment maneuvers (RM) in 17 patients with acute respiratory distress syndrome (ARDS) ventilated with a lung protective strategy. RM consisted of 2 min of pressure-controlled ventilation at a peak pressure of 50 cm H(2)O and a positive end-expiratory pressure (PEEP) above the upper inflection point of the respiratory pressure-volume curve obtained at zero PEEP. In eight patients, RM were repeated in the late phase of ARDS. Oxygenation did not change 15 min after RM in the early and late phase of ARDS. When Pa(O(2))/fraction of inspired oxygen (FI(O(2))) increased during RM, venous admixture (Q VA/Q T) decreased. The opposite occurred in patients in whom Pa(O(2))/FI(O(2)) decreased during RM. RM-induced changes in cardiac output were not observed. A significant correlation was found between RM-induced changes in Pa(O(2))/FI(O(2)) during the RM and changes in respiratory system compliance at 15 min (r = 0.66, p < 0.01) and RM-induced changes in Q VA/Q T (r = -0.85; p < 0.01). The correlation between RM-induced changes in Pa(O(2))/FI(O(2)) in responders (improvement in Pa(O(2))/FI(O(2)) of greater than 20% during the RM) and the inspired oxygen fraction was also significant. In ARDS patients ventilated with a lung protective strategy we conclude that RM have no short-term benefit on oxygenation, and regional alveolar overdistension capable of redistributing blood flow can occur during RM.


Subject(s)
Positive-Pressure Respiration , Respiratory Distress Syndrome/physiopathology , Respiratory Distress Syndrome/therapy , Adult , Aged , Blood Gas Analysis , Female , Hemodynamics/physiology , Humans , Lung Compliance/physiology , Lung Volume Measurements , Male , Middle Aged , Pulmonary Gas Exchange/physiology , Respiratory Mechanics/physiology , Tidal Volume/physiology
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