Efficacy and safety of etomidate-based sedation compared with propofol-based sedation during ERCP in low-risk patients: a double-blind, randomized, noninferiority trial

2018 ◽  
Vol 87 (1) ◽  
pp. 174-184 ◽  
Author(s):  
Chan Hyuk Park ◽  
Se Woo Park ◽  
Bomi Hyun ◽  
Jin Lee ◽  
Sea Hyub Kae ◽  
...  
Keyword(s):  
Low Risk ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Noninferiority Trial ◽  
Risk Patients

scholarly journals Clinical Surveillance vs. Anticoagulation For low-risk patiEnts with isolated SubSegmental Pulmonary Embolism: protocol for a multicentre randomised placebo-controlled non-inferiority trial (SAFE-SSPE)

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e040151
Author(s):  
Christine Baumgartner ◽  
Frederikus A Klok ◽  
Marc Carrier ◽  
Andreas Limacher ◽  
Jeanne Moor ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
The Netherlands ◽  
Ethics Committees ◽  
Low Risk ◽  
Resource Utilisation ◽  
Anticoagulant Treatment ◽  
Double Blind ◽  
Vein Thrombosis ◽  
Clinical Surveillance ◽  
Risk Patients

IntroductionThe clinical significance of subsegmental pulmonary embolism (SSPE) is currently unclear. Although growing evidence from observational studies suggests that withholding anticoagulant treatment may be a safe option in selected patients with isolated SSPE, most patients with this condition receive anticoagulant treatment, which is associated with a 90-day risk of recurrent venous thromboembolism (VTE) of 0.8% and major bleeding of up to 5%. Given the ongoing controversy concerning the risk-benefit ratio of anticoagulation for isolated SSPE and the lack of evidence from randomised-controlled studies, the aim of this clinical trial is to evaluate the efficacy and safety of clinical surveillance without anticoagulation in low-risk patients with isolated SSPE.Methods and analysisSAFE-SSPE (Surveillance vs. Anticoagulation For low-risk patiEnts with isolated SubSegmental Pulmonary Embolism, a multicentre randomised placebo-controlled non-inferiority trial) is an international, multicentre, placebo-controlled, double-blind, parallel-group non-inferiority trial conducted in Switzerland, the Netherlands and Canada. Low-risk patients with isolated SSPE are randomised to receive clinical surveillance with either placebo (no anticoagulation) or anticoagulant treatment with rivaroxaban. All patients undergo bilateral whole-leg compression ultrasonography to exclude concomitant deep vein thrombosis before enrolment. Patients are followed for 90 days. The primary outcome is symptomatic recurrent VTE (efficacy). The secondary outcomes include clinically significant bleeding and all-cause mortality (safety). The ancillary outcomes are health-related quality of life, functional status and medical resource utilisation.Ethics and disseminationThe local ethics committees in Switzerland have approved this protocol. Submission to the Ethical Committees in the Netherlands and Canada is underway. The results of this trial will be published in a peer-reviewed journal.Trial registration numberNCT04263038.

Efficacy and safety of flecainide in low-risk patients with chronic ventricular arrhythmias: A two-year follow-up

1989 ◽  
Vol 117 (6) ◽  
pp. 1258-1264 ◽  
Author(s):  
Mario Facchini ◽  
Tiziana Varisco ◽  
Oscar Bonazzi ◽  
Silvia G. Priori ◽  
Valeria Songa ◽  
...  
Keyword(s):  
Ventricular Arrhythmias ◽  
Low Risk ◽  
Efficacy And Safety ◽  
Risk Patients

Efficacy and safety of an early discharge protocol in low-risk patients with upper gastrointestinal bleeding

1998 ◽  
Vol 105 (3) ◽  
pp. 176-181 ◽  
Author(s):  
Pablo Moreno ◽  
Eduardo Jaurrieta ◽  
Humberto Aranda ◽  
Juan Fabregat ◽  
Leandro Farran ◽  
...  
Keyword(s):  
Gastrointestinal Bleeding ◽  
Upper Gastrointestinal Bleeding ◽  
Early Discharge ◽  
Low Risk ◽  
Efficacy And Safety ◽  
Risk Patients ◽  
Discharge Protocol ◽  
Upper Gastrointestinal

P2773Evaluation of the bleeding prediction score VTE-BLEED for predicting recurrent VTE

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
F A Klok ◽  
E Presles ◽  
C Tromeur ◽  
S Barco ◽  
S V Konstantinides ◽  
...  
Keyword(s):  
High Risk ◽  
Anticoagulant Therapy ◽  
Major Bleeding ◽  
Low Risk ◽  
Potential Yield ◽  
Double Blind ◽  
Increased Risk ◽  
Risk Patients ◽  
Recurrent Vte ◽  
Post Hoc

Abstract Introduction VTE-BLEED is a validated score for identification of patients at a 3 to 5-fold increased risk of major bleeding during extended anticoagulation for venous thromboembolism (VTE; table 1). It is unknown whether VTE-BLEED high-risk patients also have an increased risk for recurrent VTE, which would limit the potential usefulness of the score. Methods This was a post-hoc analysis of the randomised double-blind placebo-controlled PADIS-PE trial, in which patients with a first unprovoked pulmonary embolism (PE) initially treated for 6 months were randomised to receive an additional 18-month of warfarin versus placebo. Primary outcome of the current analysis was recurrent VTE during 2-year follow-up after anticoagulant discontinuation, i.e. after the initial 6-month treatment in the placebo arm and after 24 months of anticoagulation in the active treatment arm. This rate, adjusted on study treatment allocation, was compared between patients in the high- versus low-risk VTE-BLEED group. Results In complete case analysis (n=308; 82.4% of total population), 89 (28.9%) patients were classified as VTE-BLEED high risk. A total of 44 VTE events occurred after anticoagulant discontinuation during 668 patient-years. The cumulative incidence of recurrent VTE was 16.4% (95% CI 10.0–26.1%; 14 events) and 14.6% (95% CI 10.4–20.3%; 30 events) in the high-risk and low-risk VTE-BLEED groups, respectively, for an adjusted Hazard Ratio of 1.16 (95% CI 0.62–2.19; Figure 1). Figure 1 Conclusion In this study, patients with unprovoked PE classified at high risk of major bleeding by VTE-BLEED did not have a higher incidence of recurrent VTE after cessation of anticoagulant therapy, supporting the potential yield of the score for making management decisions on the optimal duration of anticoagulant therapy.

Exploring the Validity and Operational Impact of Using Allied Health Assistants to Conduct Dysphagia Screening for Low-Risk Patients Within the Acute Hospital Setting

2020 ◽  
Vol 29 (4) ◽  
pp. 1944-1955 ◽  
Author(s):  
Maria Schwarz ◽  
Elizabeth C. Ward ◽  
Petrea Cornwell ◽  
Anne Coccetti ◽  
Pamela D'Netto ◽  
...  
Keyword(s):  
At Risk ◽  
Allied Health ◽  
Assessment Tool ◽  
Hospital Setting ◽  
Low Risk ◽  
False Negatives ◽  
Exact Agreement ◽  
Risk Patients ◽  
Impact Phase ◽  
Operational Impact

Purpose The purpose of this study was to examine (a) the agreement between allied health assistants (AHAs) and speech-language pathologists (SLPs) when completing dysphagia screening for low-risk referrals and at-risk patients under a delegation model and (b) the operational impact of this delegation model. Method All AHAs worked in the adult acute inpatient settings across three hospitals and completed training and competency evaluation prior to conducting independent screening. Screening (pass/fail) was based on results from pre-screening exclusionary questions in combination with a water swallow test and the Eating Assessment Tool. To examine the agreement of AHAs' decision making with SLPs, AHAs ( n = 7) and SLPs ( n = 8) conducted an independent, simultaneous dysphagia screening on 51 adult inpatients classified as low-risk/at-risk referrals. To examine operational impact, AHAs independently completed screening on 48 low-risk/at-risk patients, with subsequent clinical swallow evaluation conducted by an SLP with patients who failed screening. Results Exact agreement between AHAs and SLPs on overall pass/fail screening criteria for the first 51 patients was 100%. Exact agreement for the two tools was 100% for the Eating Assessment Tool and 96% for the water swallow test. In the operational impact phase ( n = 48), 58% of patients failed AHA screening, with only 10% false positives on subjective SLP assessment and nil identified false negatives. Conclusion AHAs demonstrated the ability to reliably conduct dysphagia screening on a cohort of low-risk patients, with a low rate of false negatives. Data support high level of agreement and positive operational impact of using trained AHAs to perform dysphagia screening in low-risk patients.

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