Prevention of invasive ventilation (PRiVENT)-a prospective, mixed-methods interventional, multicentre study with a parallel comparison group: study protocol.

BACKGROUND: Invasive mechanical ventilation (IMV) is a standard therapy for intensive care patients with respiratory failure. With increasing population age and multimorbidity, the number of patients who cannot be weaned from IMV increases, resulting in impaired quality of life and high costs. In addition, human resources are tied up in the care of these patients. METHODS: The PRiVENT intervention is a prospective, mixed-methods interventional, multicentre study with a parallel comparison group selected from insurance claims data of the health insurer Allgemeine Ortskrankenkasse Baden-Württemberg (AOK-BW) conducted in Baden-Württemberg, Germany, over 24 months. Four weaning centres supervise 40 intensive care units (ICUs), that are responsible for patient recruitment. The primary outcome, successful weaning from IMV, will be evaluated using a mixed logistic regression model. Secondary outcomes will be evaluated using mixed regression models. DISCUSSION: The overall objective of the PRiVENT project is the evaluation of strategies to prevent long-term IMV. Additional objectives aim to improve weaning expertise in and cooperation with the adjacent Intensive Care Units. TRIAL REGISTRATION: This study is registered at ClinicalTrials.gov (NCT05260853).

Impact of the COVID-19 pandemic on the behaviour and health status of patients with COPD: results from the German COPD cohort COSYCONET.

BACKGROUND: Infection control measures for coronavirus disease 2019 (COVID-19) might have affected management and clinical state of patients with COPD. We analysed to which extent this common notion is fact-based. METHODS: Patients of the COSYCONET cohort were contacted with three recurring surveys (COVID1, 2 and 3 at 0, 3 and 6 months, respectively). The questionnaires comprised behaviour, clinical and functional state, and medical treatment. The responses to the questionnaires were compared amongst themselves and with pre-COVID information from the last visit of COSYCONET. RESULTS: Overall, 594 patients were contacted and 375 patients (58% males, forced expiratory volume in 1 s (FEV1) 61±22% predicted) provided valid data in COVID1 and COVID2. Five patients reported infections with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Most patients - except for patients with higher education - reported compliance with recommended protective measures, whereby compliance to hygiene, contact and access to physicians slightly improved between COVID1 and COVID2. Also, patients obtained more information from physicians than from public media. In the majority of cases, the personal physician could not be substituted by remote consultation. Over time, symptoms slightly increased and self-assessed physical capacity decreased. Results of COVID3 were similar. Women and patients with more exacerbations and dyspnoea avoided medical consultations, whereas Global Initiative for Chronic Obstructive Lung Disease (GOLD) D patients were more amenable to tele-consultation. CONCLUSION: In well-characterised COPD patients, we observed on average slight deteriorations of clinical state during the period of COVID-19 restrictions, with high and partially increasing adherence to protective measures. The data suggest that in particular, women and GOLD D patients should be actively contacted by physicians to identify deteriorations.