Safety and Outcome of High-Flow Nasal Oxygen Therapy Outside ICU Setting in Hypoxemic Patients With COVID-19∗

OBJECTIVE: High-flow nasal oxygen (HFNO) therapy is frequently applied outside ICU setting in hypoxemic patients with COVID-19. However, safety concerns limit more widespread use. We aimed to assess the safety and clinical outcomes of initiation of HFNO therapy in COVID-19 on non-ICU wards. DESIGN: Prospective observational multicenter pragmatic study. SETTING: Respiratory wards and ICUs of 10 hospitals in The Netherlands. PATIENTS: Adult patients treated with HFNO for COVID-19-associated hypoxemia between December 2020 and July 2021 were included. Patients with treatment limitations were excluded from this analysis. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Outcomes included intubation and mortality rate, duration of hospital and ICU stay, severity of respiratory failure, and complications. Using propensity-matched analysis, we compared patients who initiated HFNO on the wards versus those in ICU. Six hundred eight patients were included, of whom 379 started HFNO on the ward and 229 in the ICU. The intubation rate in the matched cohort (n = 214 patients) was 53% and 60% in ward and ICU starters, respectively (p = 0.41). Mortality rates were comparable between groups (28-d [8% vs 13%], p = 0.28). ICU-free days were significantly higher in ward starters (21 vs 17 d, p &lt; 0.001). No patient died before endotracheal intubation, and the severity of respiratory failure surrounding invasive ventilation and clinical outcomes did not differ between intubated ward and ICU starters (respiratory rate-oxygenation index 3.20 vs 3.38; Pao2:Fio2ratio 65 vs 64 mm Hg; prone positioning after intubation 81 vs 78%; mortality rate 17 vs 25% and ventilator-free days at 28 d 15 vs 13 d, all p values &gt; 0.05). CONCLUSIONS: In this large cohort of hypoxemic patients with COVID-19, initiation of HFNO outside the ICU was safe, and clinical outcomes were similar to initiation in the ICU. Furthermore, the initiation of HFNO on wards saved time in ICU without excess mortality or complicated course. Our results indicate that HFNO initiation outside ICU should be further explored in other hypoxemic diseases and clinical settings aiming to preserve ICU capacity and healthcare costs.</p

The INTOXICATE study: methodology and preliminary results of a prospective observational study

Background There is currently no practice-based, multicenter database of poisoned patients admitted to intensive care units (ICUs). The INTOXICATE study, endorsed by the ESICM and EAPCCT, aimed to determine the rate of eventful admissions among acutely intoxicated adult ICU patients. Methods Ethical approval was obtained for this multicenter, prospective observational study, and data-sharing agreements were signed with each participating center. An electronic case report form was used to collect data on patient demographics, exposure, clinical characteristics, investigations, treatment, and in-hospital mortality data. The primary outcome, ‘eventful admission’, was a composite outcome defined as the rate of patients who received any of the following treatments in the first 24 h after the ICU admission: oxygen supplementation with a FiO2 > 40%, mechanical ventilation, vasopressors, renal replacement therapy (RRT), cardiopulmonary resuscitation, antidotes, active cooling, fluid resuscitation (> 1.5 L of intravenous fluid of any kind), sedation, or who died in the hospital. Results Seventy-eight ICUs, mainly from Europe, but also from Australia and the Eastern Mediterranean, participated. A total of 2,273 patients were enrolled between November 2020 and June 2023. The median age of the patients was 41 years, 72% were exposed to intoxicating drugs. The observed rate of patients with an eventful ICU admission was 68% (n = 1546/2273 patients). The hospital mortality was 4.5% (n = 103/2273). Conclusions The vast majority of patients survive, and approximately one third of patients do not receive any ICU-specific interventions after admission in an intensive care unit for acute intoxication. High-quality detailed clinical data have been collected from a large cohort of acutely intoxicated ICU patients, providing information on the pattern of severe acute poisoning requiring intensive care admission and the outcomes of these patients. Trial registration: OSF registration ID: osf.io/7e5uy

Procedural Rights and Obligations of Third Parties in Antitrust Investigations and Proceedings by the European Commission

This Article provides a systematic overview of the procedural rights and obligations of third parties in investigations and proceedings conducted by the European Commission for the enforcement of Articles 101 and 102 TFEU. Third parties are all natural or legal persons, undertakings and associations of undertakings other than those under investigation. This article examines the possibilities for third parties to inform the European Commission about a suspected infringement and to trigger an investigation by the European Commission; the obligations and rights of third parties when responding to requests for information sent to them by the European Commission, when participating in interviews, and when submitting to inspections conducted by the European Commission; the possibilities for third parties to obtain information about pending proceedings and to express their views in them; the rules on the use of languages; and the protection of business secrets and other confidential information, and the restrictions on the use of information obtained by third parties through their participation in the European Commission’s proceedings. Procedural rights and obligations, Third parties, Antitrust proceedings and investigations, European Commission, Enforcement of Articles 101 and 102 TFEU, Informants, Requests for information, Inspections, Use of languages, Protection of confidential information</jats:p

The Modernization of the Enforcement of Articles 81 and 82 EC: A Legal and Economic Analysis of the Commission\u27s Proposal for a New Council Regulation Replacing Regulation No. 17

The purpose of this Essay is to analyze the proposed new regime for the enforcement of Articles 81 and 82 of the EC Treaty, compared with the current situation under Regulation No. 17, in the light of the four dimensions which have just been identified. The issue of timing of legal intervention is discussed first. Indeed, the most important aspect of the proposed reform is the abandonment of the current (pretence at) ex ante enforcement through prescreening and the move to a pure system of ex post enforcement through deterrence. The following section looks at the role of the competition authorities of the Member States (hereafter also called “national competition authorities”) versus the European Commission. The proposed reform facilitates the enforcement of Articles 81 and 82 EC by the national competition authorities, by removing the Commission\u27s current monopoly for the application of Article 81(3), while providing for increased cooperation among the competition authorities of the different Member States and the Commission within a coherent network. The next section considers the role of private parties in the enforcement of Articles 81 and 82 EC, and the role of national courts. The main change here is that the proposed new regulation empowers national courts, when called upon to apply Article 81(1), to apply also Article 81(3) themselves. The following section deals with sanctions, in respect of which no major changes are proposed by the Commission. The final section contains a short conclusion

The Judgment of the EU General Court in <i>Intel</i> and the So-Called More Economic Approach to Abuse of Dominance

This article discusses the judgment of the EU General Court of 12 June 2014 in the Intel case. It argues that the EU case law on the use of exclusivity rebate systems by undertakings occupying a dominant position is economically sound, and that the criticism directed at this case law is ill-founded.</jats:p

Efficiency and justice in European antitrust enforcement /

"In the last few years, the public enforcement of Articles 81 and 82 EC has been thoroughly transformed: the competition authorities of the EU Member States have become active enforcers within the European Competition Network, the European Commission has imposed more and higher fines than ever before, leniency has become a major instrument of cartel detection, and some Member States have introduced criminal penalties. The overall trend towards more and stronger enforcement of Articles 81 and 82 EC has also rekindled discussion on the old question of how to strike the right balance between efficient enforcement and adequate protection of the rights of the defence. This book brings together six essays which analyse from both a legal and an economic perspective the powers of investigation of the European Commission and the competition authorities of the Member States, and the corresponding procedural rights and guarantees, the use of settlements, the theory and practice of fines and of leniency, and the criminalization of European antitrust enforcement."--Bloomsbury Publishing