scholarly journals Non-invasive indirect monitoring of intra-abdominal pressure using microwave reflectometry: system design and proof-of-concept clinical trial

2020 ◽  
Author(s):  
Marcelo David ◽  
Aviad Raviv ◽  
Ariel Guttel ◽  
Valentina García Reyes ◽  
Franco Simini ◽  
...  
Keyword(s):  
Clinical Trial ◽  
System Design ◽  
Abdominal Pressure ◽  
Proof Of Concept ◽  
Non Invasive

scholarly journals Direct antivirals working against the novel coronavirus: azithromycin (DAWn-AZITHRO), a randomized, multicenter, open-label, adaptive, proof-of-concept clinical trial of new antivirals working against SARS-CoV-2—azithromycin trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Iwein Gyselinck ◽  
◽  
Laurens Liesenborghs ◽  
Ewout Landeloos ◽  
Ann Belmans ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Standard Of Care ◽  
Ordinal Scale ◽  
Cytokine Signaling ◽  
Nasopharyngeal Swab ◽  
The Novel ◽  
Proof Of Concept ◽  
Open Label ◽  
Novel Coronavirus

Abstract Background The rapid emergence and the high disease burden of the novel coronavirus SARS-CoV-2 have created a medical need for readily available drugs that can decrease viral replication or blunt the hyperinflammatory state leading to severe COVID-19 disease. Azithromycin is a macrolide antibiotic, known for its immunomodulatory properties. It has shown antiviral effect specifically against SARS-CoV-2 in vitro and acts on cytokine signaling pathways that have been implicated in COVID-19. Methods DAWn-AZITHRO is a randomized, open-label, phase 2 proof-of-concept, multicenter clinical trial, evaluating the safety and efficacy of azithromycin for treating hospitalized patients with COVID-19. It is part of a series of trials testing promising interventions for COVID-19, running in parallel and grouped under the name DAWn-studies. Patients hospitalized on dedicated COVID wards are eligible for study inclusion when they are symptomatic (i.e., clinical or radiological signs) and have been diagnosed with COVID-19 within the last 72 h through PCR (nasopharyngeal swab or bronchoalveolar lavage) or chest CT scan showing typical features of COVID-19 and without alternate diagnosis. Patients are block-randomized (9 patients) with a 2:1 allocation to receive azithromycin plus standard of care versus standard of care alone. Standard of care is mostly supportive, but may comprise hydroxychloroquine, up to the treating physician’s discretion and depending on local policy and national health regulations. The treatment group receives azithromycin qd 500 mg during the first 5 consecutive days after inclusion. The trial will include 284 patients and recruits from 15 centers across Belgium. The primary outcome is time from admission (day 0) to life discharge or to sustained clinical improvement, defined as an improvement of two points on the WHO 7-category ordinal scale sustained for at least 3 days. Discussion The trial investigates the urgent and still unmet global need for drugs that may impact the disease course of COVID-19. It will either provide support or else justify the discouragement of the current widespread, uncontrolled use of azithromycin in patients with COVID-19. The analogous design of other parallel trials of the DAWN consortium will amplify the chance of identifying successful treatment strategies and allow comparison of treatment effects within an identical clinical context. Trial registration EU Clinical trials register EudraCT Nb 2020-001614-38. Registered on 22 April 2020

scholarly journals Correction to: A randomized, open-label, adaptive, proof-of-concept clinical trial of modulation of host thromboinflammatory response in patients with COVID-19: the DAWn-Antico study

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
T. Vanassche ◽  
◽  
M. M. Engelen ◽  
Q. Van Thillo ◽  
J. Wauters ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Proof Of Concept ◽  
Open Label

An amendment to this paper has been published and can be accessed via the original article.

scholarly journals A phase IIa proof-of-concept, placebo-controlled, randomized, double-blind, crossover, single-dose clinical trial of a new class of bronchodilator for acute asthma

Trials ◽  
2018 ◽  
Vol 19 (1) ◽  
Author(s):  
Veronica Swystun ◽  
Francis H. Y. Green ◽  
John H. Dennis ◽  
Emmanouil Rampakakis ◽  
Gurkeet Lalli ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Single Dose ◽  
Acute Asthma ◽  
Proof Of Concept ◽  
Double Blind ◽  
New Class

Capnography and Pulse Oximetry Improve Fast Track Extubation in Patients Undergoing Coronary Artery Bypass Graft Surgery: A Randomized Clinical Trial

2021 ◽  
Author(s):  
Seyed Tayeb Moradian ◽  
Fatemah Beitollahi ◽  
Mohammad Saeid Ghiasi ◽  
Amir vahedian-azimi
Keyword(s):  
Clinical Trial ◽  
Pulse Oximetry ◽  
Fast Track ◽  
Artery Bypass ◽  
Bypass Graft ◽  
Intervention Group ◽  
Control Group ◽  
Artery Bypass Graft ◽  
Cabg Surgery ◽  
Non Invasive

Abstract Background Use of capnography as a non-invasive method during the weaning process for fast track extubation (FTE) is controversial. We conducted the present study to determine whether pulse oximetry and capnography could be utilized as alternatives to arterial blood gas (ABG) measurements in patients under mechanical ventilation (MV) following coronary artery bypass graft (CABG) surgery. Methods In this randomized clinical trial, 70 patients, who were candidates for CABG surgery, were randomly assigned into two equal groups (n = 35); the intervention group and the control group. In the intervention group, the ventilator management and weaning from MV was done using Etco2 from capnography and SpO2 from pulse oximetry. Meanwhile, in the control group, weaning was done based on ABG analysis. The length of intensive care unit (ICU) stay, time to extubation, number of manual ventilator setting changes, and alarms were compared between the groups. Results The end-tidal carbon dioxide (ETCO2) levels in the intervention group were completely similar to the partial pressure of carbon dioxide (PaCo2) in the control group (39.5 ± 3.1 vs. 39.4 ± 4.32, P > 0.05). The mean extubation times were significantly shorter in the intervention group compared to those in the control patients (212.2 ± 80.6 vs. 342.7 ± 110.7, P < 0.001). Moreover, the number of changes in the manual ventilator setting and the number of alarms were lower in the intervention group (P < 0.05). However, the differences in the length of stay in ICU between the two groups were not significant (P = 0.219). Conclusion According to our results, the use of non-invasive monitors, including capnography and pulse oximetry, is emphasized in order to utilize FTE after CABG surgery. Furthermore, it is a safe and valuable monitor that could be a good alternative for ABG in this population. Nevertheless, further studies with larger sample sizes and on different disease states and populations are required to assess the accuracy of our findings. Trial registration: IRCT, IRCT201701016778N6, Registered 3 March 2017, https://www.irct.ir/trial/7192

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