Protocol for detecting unrecognized sleep apnea in patients with atrial fibrillation by a home-monitoring device: the DAN-APNO study.

BACKGROUND: Determining the presence of modifiable risk factors for atrial fibrillation (AF), such as sleep apnea is of clinical importance due to the potential impact targeting these risk factors can have on the progression and burden of AF. Using new digital-based technology is a promising solution to the underreporting of sleep apnea highlighted by academical societies in recent years. The aim of this study is to report the prevalence and severity of sleep apnea in patients with AF and, secondarily, assess the accuracy and feasibility of a new home-screening device for sleep apnea (NightOwl™ by Ectosense). METHODS: DAN-APNO is a cross-sectional study at the Department of Cardiology, Herlev-Gentofte Hospital recruiting patients with AF referred to anticoagulation initiation aged 18 to 90 years without known sleep apnea. At least 150 patients will be recruited and undergo medical history, clinical evaluation, several sleep-apnea questionnaires, and a sleep-recording evaluation for four nights with sleep apnea home-monitoring device NightOwl™. Additionally, the first 20 participants and participants with moderate-severe sleep apnea by screening are referred to cardio-respiratory monitoring (CRM). This clinical evaluation allows the comparison of standard evaluation method and the NightOwl™. Clinical measures include Apnea-Hypopnea Index (AHI), Oxygen Desaturation Index (ODI), pulse rate, as well as questionaries about sleep apnea assessment and the clinical feasibility of the NightOwl™ device. Main outcomes comprise analysis of the prevalence and severity of sleep apnea, and clinical and demographic predictors of moderate and severe sleep apnea. In addition, correlation analyses for accuracy measures between CRM and NightOwl™ will be conducted along with patient ease-of-use and satisfaction questionnaires. DISCUSSION: This study is limited by selection bias; only patients with atrial fibrillation from anticoagulation clinic is asked to participate, which could limit the generalizability of our results. However, this study aims to test whether a miniaturized simple home-monitoring device for detecting sleep apnea in patients with AF potentially can evaluate sleep apnea more conveniently and easier. Trial Registration The study is registered the 18-02-2021 at clinicaltrials.gov with registration number: NCT04760002.

A multi-center randomized, controlled, open-label trial evaluating the effects of eosinophil-guided corticosteroid-sparing therapy in hospitalised patients with COPD exacerbations - The CORTICO steroid reduction in COPD (CORTICO-COP) study protocol.

BACKGROUND: The most commonly applied treatment for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) is a 5-day course of high-dose systemic corticosteroids. However, this treatment has not been shown to reduce mortality and can potentially have serious side effects. Recent research has shown that, presumably, only a subgroup of COPD patients identifieable by blood eosinophil count benefit from a rescue course of prednisolone. By applying a biomarker-guided strategy, the aim of this study is to determine whether it is possible to reduce the use of systemic corticosteroids in AECOPD without influencing the outcome. METHODS: This is an ongoing prospective multicenter randomized controlled open label trial comprising 320 patients with AECOPD recruited from four hospitals in Denmark. The patients are randomized 1:1 to either standard care or eosinophil-guided corticosteroid-sparing therapy where prednisolone is not administered if the daily blood sampling reveals an eosinophil level below 0.3 × 109 cells/L. The primary endpoint is length of hospital stay within 14 days after recruitment. The secondary endpoints are treatment failure, 30-day mortality rate, COPD related re-admission rate, change in FEV1, and a number of adverse effect measures obtained within 3 months after the index hospitalisation date related to corticosteroid usage. DISCUSSION: This will be a very large RCT providing knowledge about the effectiveness of individualized biomarker-guided corticosteroid therapy in hospitalised patients with AECOPD. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02857842 , 02-august-2016. Clinicaltrialregister.eu: Classification Code: 10,010,953, 02-marts-2016.

Routine examination for tuberculosis is still indicated during bronchoscopy for pulmonary infiltrates.

INTRODUCTION: Tuberculosis (TB) can present in numerous ways and can be radiological indistinguishable from cancer. In several guidelines for bronchoscopy (FOB) in low-incidence areas, a Mycobacterium tuberculosis test is only recommended when TB is clinically suspected. Due to the expenses associated with M. tuberculosis cultures, we did an analysis of tests obtained by FOB and other invasive procedures (endoscopic ultrasound (EUS)-guided needle biopsy via the oesophagus or trachea and percutaneous needle lung biopsy (PNLB)). METHODS: All patients tested positive for M. tuberculosis by culture and with samples obtained by FOB, EUS or PNLB in the 2008-2012 period were identified retrospectively in two centres in a low-incidence area (Copenhagen, Denmark). Patient records and radiological reports were reviewed. RESULTS: A total of 57 (1.2%) patients out of the 4,680 tested were M. tuberculosis culture positive. Of the 57 patients, 40.3% (n = 23) presented with isolated upper lobe infiltrates and 29.8% (17) with cavitating infiltrates. Isolated chest lymphadenopathy was seen in 8.8% (n = 5). In 33.3% (n = 19) of the patients, radiography was not typical of TB (not upper lobe, no cavity, not isolated lympadenopathy, not miliary). Of the 57 patients, 48 were diagnosed by FOB, six by EUS and three by PNLB. M. tuberculosis samples were taken in an estimated 34% of all procedures. CONCLUSION: M. tuberculosis culturing should always be considered when performing FOB in patients with lung infiltrates of unknown origin, even in a low-incidence country as Denmark. EUS and PNLB should also be considered when sampling material. FUNDING: not relevant. TRIAL REGISTRATION: not relevant.

Evaluation of the decision support system for antimicrobial treatment, TREAT, in an acute medical ward of a university hospital.

OBJECTIVES: TREAT, a decision support system for antimicrobial therapy, was implemented in an acute medical ward. METHODS: Patients admitted on suspicion of infection were included in the study. The evaluation of TREAT was done both retrospectively and prospectively. Coverage of empirical antimicrobial treatments was compared to recommendations from TREAT and the optimal use of local guidelines. RESULTS: Five hundred and eleven patients were included, of whom 162 had a microbiologically documented infection. In the retrospective part of the study, TREAT, physician, and guideline antimicrobial coverage rates were 65%, 51%, and 79%, respectively, and in the prospective part, 68%, 62%, and 77%, respectively. TREAT provided lower coverage than local guidelines (p<0.001), but was similar to the performance of physicians in a university hospital (p=0.069). No differences were found in length of hospital stay, or hospital or 30-day mortality. Direct costs were significantly higher for TREAT advice than for local guidelines or the physician prescriptions (p<0.001), but the ecological costs were lower for TREAT advice than for both local guidelines (p<0.001) and physician prescriptions (p=0.247). The coverage of TREAT advice for the bacteraemia patients was non-inferior to the physicians (p=1.00). CONCLUSIONS: TREAT can potentially improve the ecological costs of empirical antimicrobial therapy for patients in acute medical wards, but provided lower coverage than local guidelines.