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Greenfield Park, Canada

Background: Coughing episodes occur frequently at extubation after thoracic surgery, and this may be due in part to the double-lumen tube (DLT). In this study, the DLT was replaced with either a single-lumen endotracheal tube (ETT) or a laryngeal mask airway (LMA) device or left in place, and the incidence of coughing at emergence was compared between the three groups. Methods: Fifty-eight adults scheduled for thoracic surgery with a DLT were included. Exclusion criteria were an anticipated difficult airway, obesity, and contraindication to the use of an LMA ProSeal™ (LMA-P). After surgery but before emergence, patients were randomized to having the DLT (1) removed and replaced by an LMA-P (LMA-P Group), (2) removed and replaced by an ETT (ETT Group), or (3) left in place (DLT Group). The primary outcome was the number of coughing episodes at extubation. Results: Among 184 patients screened, 124 did not meet inclusion criteria, and two patients, both in the ETT Group, were excluded after randomization, leaving 20, 18, and 20 patients in the LMA-P, ETT, and DLT Groups, respectively. There were fewer coughing episodes (median [quartiles]) in the LMA-P Group than in the DLT Group (0[0-1] vs 2[1-3], respectively; P = 0.01). In the DLT Group, 90% of patients coughed at least once. This incidence was not significantly different in the ETT Group (83%; P = 0.222) but was significantly reduced in the LMA-P Group (35%; P < 0.001). No patient had oxygen desaturation during airway exchange or at extubation. The incidence and severity of hoarseness and sore throat were similar in all groups. Conclusion: Coughing at extubation after thoracic surgery can be reduced if the DLT is replaced by an LMA-P before emergence. The number of patients in this trial was too small to evaluate the risks associated with exchanging the airway device. This trial was registered at ClinicalTrials.gov: NCT00925613. © 2015, Canadian Anesthesiologists' Society. Source

Stanish W.D.,Dalhousie University | McCormack R.,University of British Columbia | Forriol F.,University of San Pablo - CEU | Mohtadi N.,University of Calgary | And 3 more authors.
Journal of Bone and Joint Surgery - Series A

Background: Microfracture, the standard of care, is recognized to be an incomplete solution for cartilage damage. BST-CarGel, a chitosan-based medical device, is mixed with autologous whole blood and is applied to a microfractured cartilage lesion in which it physically stabilizes the clot and guides and enhances marrow-derived repair. An international, multicenter, randomized controlled trial was conducted to evaluate BST-CarGel treatment compared with microfracture alone in the repair of cartilage lesions in the knee. Methods: Eighty patients between the ages of eighteen and fifty-five years with a single, symptomatic focal lesion on the femoral condyles were randomized to BST-CarGel and microfracture treatment (n = 41) or microfracture treatment alone (n = 39). The primary end points of repair tissue quantity and quality at twelve months were assessed by quantitative three-dimensional magnetic resonance imaging measuring the degree of lesion filling and T2 relaxation time with use of standardized one and twelve-month posttreatment scans. The secondary end point at twelve months was clinical benefit determined with the Western Ontario and McMaster Universities Osteoarthritis Index. The tertiary end point was quality of life determined by the Short Form-36. Safety was assessed through the recording of adverse events. Results: Patient baseline characteristics were similar in the two groups, although baseline lesion areas were slightly larger on quantitative magnetic resonance imaging for the BST-CarGel group compared with the microfracture group. Blinded quantitative magnetic resonance imaging analysis demonstrated that, at twelve months, when compared with microfracture treatment alone, BST-CarGel treatment met both primary end points by achieving statistical superiority for greater lesion filling (p = 0.011) and more hyaline cartilage-like T2 values (p = 0.033). The lesion filling values were 92.8% ± 2.0% for the BSTCarGel treatment group and 85.2% ± 2.1% for the microfracture treatment group, and the mean T2 values were 70.5 ± 4.5ms for the BST-CarGel treatment group and 85.0 ± 4.9 ms for the microfracture treatment group. Western Ontario and McMaster Universities Osteoarthritis Index subscales for pain, stiffness, and function yielded equivalent improvement for both groups at twelve months, which were significant (p < 0.0001) from baseline. Treatment safety profiles were considered comparable. Conclusions: At twelve months, BST-CarGel treatment resulted in greater lesion filling and superior repair tissue quality compared with microfracture treatment alone. Clinical benefit was equivalent between groups at twelve months, and safety was similar. Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence. Copyright © 2013 by the journal of bone and joint surgery, incorporated. Source

Lu C.,University of Texas M. D. Anderson Cancer Center | Lee J.J.,University of Texas M. D. Anderson Cancer Center | Komaki R.,University of Texas M. D. Anderson Cancer Center | Herbst R.S.,University of Texas M. D. Anderson Cancer Center | And 10 more authors.
Journal of the National Cancer Institute

Background AE-941 is a standardized aqueous shark cartilage extract with antiangiogenic properties that has previously been evaluated in phase I and II clinical trials. Our objective was to determine the effect of adding AE-941 to chemoradiotherapy on overall survival of patients with unresectable stage III non-small cell lung cancer (NSCLC). Methods A randomized, double-blinded, placebo-controlled, phase III clinical trial was designed to test the efficacy of AE-941 in unresectable stage III NSCLC patients who were treated with chemoradiotherapy. Between June 5, 2000, and February 6, 2006, 379 eligible patients were enrolled in community and academic oncology centers across the United States and Canada. In February 2006, the trial was closed to new patient entry before meeting the target sample size because of insufficient accrual. All subjects received induction chemotherapy followed by concurrent chemotherapy with chest radiotherapy. Each participating center administered one of the two chemotherapy regimens, either carboplatin and paclitaxel, or cisplatin and vinorelbine. The primary endpoint was overall survival, and secondary endpoints were time to progression, progression-free survival, tumor response rate, and toxic effects. Event-time distributions were estimated by the Kaplan-Meier method. All statistical tests were two-sided. Results There was no statistically significant difference in overall survival between the chemoradiotherapy plus AE-941 group (n = 188; median survival = 14.4 months, 95% confidence interval = 12.6 to 17.9 months) and the chemoradiotherapy plus placebo group (n = 191; median survival = 15.6 months, 95% confidence interval = 13.8 to 18.1 months) (P =. 73). Time to progression, progression-free survival, and tumor response rates were not statistically significantly different between the AE-941 and the placebo groups. No differences between the two groups were observed in common grade 3 or higher toxic effects attributable to chemoradiotherapy. Conclusions The addition of AE-941 to chemoradiotherapy did not improve overall survival in patients with unresectable stage III NSCLC. This study does not support the use of shark cartilage-derived products as therapy for lung cancer. © 2010 The Author. Source

The purpose of this hermeneutic phenomenological study (Benner, 1994) was to understand the meaning of the experience of clinical assessment of surgery nurses in a context of implementation of best practices guidelines. The study was held in an affiliated university hospital (Québec, Canada) with nine registered nurses. Data were collected through an observation period of nursing assessment and semi-structured individual interviews. The results revealed four subthemes which, combined, compose this main theme: In a context of the implementation of best practices guidelines in nursing care, clinical assessment carried out by surgery nurses is an implicit, tactful, adapted and ongoing process, facilitated by the nurse's commitment to know the patient, his history and its future in order to promote positive outcomes. Source

Kernan W.N.,Yale University | Viscoli C.M.,Yale University | Furie K.L.,Brown University | Young L.H.,Yale University | And 25 more authors.
New England Journal of Medicine

BACKGROUND: Patients with ischemic stroke or transient ischemic attack (TIA) are at increased risk for future cardiovascular events despite current preventive therapies. The identification of insulin resistance as a risk factor for stroke and myocardial infarction raised the possibility that pioglitazone, which improves insulin sensitivity, might benefit patients with cerebrovascular disease. METHODS: In this multicenter, double-blind trial, we randomly assigned 3876 patients who had had a recent ischemic stroke or TIA to receive either pioglitazone (target dose, 45 mg daily) or placebo. Eligible patients did not have diabetes but were found to have insulin resistance on the basis of a score of more than 3.0 on the homeostasis model assessment of insulin resistance (HOMA-IR) index. The primary outcome was fatal or nonfatal stroke or myocardial infarction. RESULTS: By 4.8 years, a primary outcome had occurred in 175 of 1939 patients (9.0%) in the pioglitazone group and in 228 of 1937 (11.8%) in the placebo group (hazard ratio in the pioglitazone group, 0.76; 95% confidence interval [CI], 0.62 to 0.93; P = 0.007). Diabetes developed in 73 patients (3.8%) and 149 patients (7.7%), respectively (hazard ratio, 0.48; 95% CI, 0.33 to 0.69; P<0.001). There was no significant between-group difference in all-cause mortality (hazard ratio, 0.93; 95% CI, 0.73 to 1.17; P = 0.52). Pioglitazone was associated with a greater frequency of weight gain exceeding 4.5 kg than was placebo (52.2% vs. 33.7%, P<0.001), edema (35.6% vs. 24.9%, P<0.001), and bone fracture requiring surgery or hospitalization (5.1% vs. 3.2%, P = 0.003). CONCLUSIONS: In this trial involving patients without diabetes who had insulin resistance along with a recent history of ischemic stroke or TIA, the risk of stroke or myocardial infarction was lower among patients who received pioglitazone than among those who received placebo. Pioglitazone was also associated with a lower risk of diabetes but with higher risks of weight gain, edema, and fracture. Copyright © 2016 Massachusetts Medical Society. Source

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