|drug1532||Muscle ultrasound Wiki||0.45|
|drug2548||Tranexamic acid tablets Wiki||0.45|
|drug1555||NK Cells Wiki||0.45|
|drug1853||Placebo oral tablet Wiki||0.08|
|D011024||Pneumonia, Viral NIH||0.11|
|D018352||Coronavirus Infections NIH||0.04|
There are 5 clinical trials
Growing evidences are showing the usefulness of lung ultrasound in patients with COVID-19. Sars-CoV-2 has now spread in almost every country in the world. In this study, the investigators share their experience and propose a standardized approach in order to optimize the use of lung ultrasound in covid-19 patients. The investigators focus on equipment, procedure, classification and data-sharing.
Description: Scoring procedures Score 0: The pleura line is continuous, regular. Horizontal artifacts (A-line) are present. These artifacts are generally referred as A-lines. Score 1: The pleura line is indented. Below the indent, vertical areas of white are visible. Score 2: The pleura line is broken. Below the breaking point, small to large consolidated areas (darker areas) appear with associated areas of white below the consolidated area (white lung). Score 3: The scanned area shows dense and largely extended white lung with or without larger consolidations At the end of the procedure, the clinician will write for each area the highest score obtained.Measure: Lung ultrasound grading system for COVID-19 pneumonia Time: At enrollment.
COVID-19 is a rapidly spreading and very contagious disease caused by a novel coronavirus that can lead to respiratory insufficiency. In many patients, the chest radiograph at first presentation be normal, and early low-dose CT-scan is advocated to diagnose viral pneumonia. Lung ultrasound (LUS) has similar diagnostic properties as CT for diagnosing pneumonia. However, it has the advantage that it can be performed at point-of-care, minimizing the need to transfer the patient, reducing the number of health care personnel and equipment that come in contact with the patient and thus potentially decrease the risk of spreading the infection. This study has the objective to examine the accuracy of lung ultrasound in patients with proven COVID-19 pneumonia.
Description: The diagnostic accuracy of lung ultrasound is more than 90% compared to low-dose CT or chest X-ray for the detection of viral pneumonia in patients with COVID-19 infection.Measure: Accuracy of the diagnosis of interstitial syndrome by lung ultrasound Time: within 2 weeks after first subject included
Description: The interobserver variability by lung ultrasound between the 2 observers for the diagnosis of interstitial syndrome by lung ultrasound is > 0.6 measured by the Kappa scoreMeasure: Inter-observer variability Time: within 2 weeks after first subject included
This observational study is designed to assess whether focused lung ultrasound examination can improve the diagnosis of COVID-19 lung disease and/or make an alternative diagnosis at a patient's initial hospital presentation. For patients with confirmed COVID-19 the study will also assess whether surveillance lung ultrasound examination can predict clinical outcome over the course of their hospital admission.
Description: Primary and blinded scorer diagnosis of COVID-19 on lung ultrasoundMeasure: Diagnosis of COVID-19 on lung ultrasound Time: On day of admission to hospital
Description: Primary and blinded scorer diagnosis of COVID-19 on lung ultrasound vs. radiologist-reported chest x-ray findingsMeasure: Difference in diagnosis of COVID-19 on lung ultrasound vs. chest x-ray Time: On day of admission to hospital
Description: Primary and blinded scorer diagnosis of alternative condition on lung ultrasoundMeasure: Diagnosis of alternative condition to COVID-19 on lung ultrasound vs. chest x-ray Time: On day of admission to hospital
Description: Comparison of lung ultrasound findings with clinical markers of COVID-19 disease severity e.g. supplementary oxygen requirementsMeasure: Ability of surveillance lung ultrasound to predict clinical trajectory / outcome in patients with COVID-19 Time: During hospital admission
Description: Comparison of primary and blinded scorer evaluation of lung ultrasound scans for consistency of interpretation and diagnosisMeasure: Consistency of lung ultrasound interpretation in patients presenting with suspected COVID-19 Time: On day of admission to hospital
The COVID-19 disease has been subject to numerous publications since its emergence. Almost 20% of people suffering from COVID-19 develop severe to critical symptoms and require hospitalization, often in Intensive Care Unit (ICU). Respiratory failure is the main reason for admission in ICU of these patients. Therapeutic strategies implemented for the management of critically-ill patients may often lead to short-term muscular and functional alterations resulting in ICU-Acquired Weakness (ICUAW). These lead to long-term disabilities expressing trough dependence and quality of life impairment of survivors. The purpose of this study is to assess the quality of life, dependence and survival at one year in patients who survived from COVID-19 in ICU and are admitted in post-ICU setting for difficult weaning purpose. Ancillary studies aim to assess the course of muscle function (atrophy, structural modifications), lung function (loss of aeration) and safety of early mobilization.
Description: Quality of life will be assessed using Short Form Health Survey (SF-36) through a phone call at one year. SF-36 score range from 0 to 100, 100 indicating a better quality of life.Measure: Mean in quality of life score at one year on the Short Form Health Survey (SF-36) Time: 1 year
Description: Quality of life will be assessed using Short Form (36) Health Survey (SF-36) through a phone call at six months. SF-36 score range from 0 to 100, 100 indicating a better quality of life.Measure: Mean in quality of life score at six months on the Short Form Health Survey (SF-36) Time: 6 months
Description: Autonomy will be assessed using Activities Daily Living (ADL) scale through a phone call at one year and six months. ADL scale range from 0 to 6, 6 indicating a better autonomy in activities daily living.Measure: Mean in autonomy score on the Activities Daily Living (ADL) scale Time: At enrollement, 6 months and 1 year
Description: Survival will be assessed using the death registry query and phone call for vital status recording at six months and one year. Survival rate will be expressed as a survival function using Kaplan Meier method.Measure: Survival rate Time: 6 months and 1 year
Description: Lung aeration will be assessed using the Lung Ultrasound Score (LUS). Patient is in semi-recumbent position (30°). Lung ultrasound will be performed in 12 thorax area: anterior, lateral and posterior, each area divided in superior and inferior area, for each hemithorax. Lung Ultrasound Score will be recorded using a convex probe with a transverse view. For each thorax area a subscore is calculated: 0 = normal profil; 1 = multiple and well-defined B-lines; 2 = confluent B-lines; 3 = lung consolidation. Sum of this subscores allows calculation of the total score out of 60. Presence of pleural thickening and subpleural consolidations will be also recorded.Measure: Change from baseline in lung ultrasound aeration score Time: Day of enrollement, day 14, day 21, day 28 and day 35 from initial admission in ICU
Description: Diaphragm Ultrasound will be used to assess diaphragm thickness and excursion. Patient is in semi-recumbent position (30°). Diaphragm thickness will be performed using intercostal view with a linear probe at the zone of apposition for assessing diaphragm thickness. M-Mode will be used to measure diaphragm thickness at inspiratory time (maximal inspiration) and expiratory time (maximal expiration). Diaphragm excursion will be measured using a subcostal anterior view with convex probe. Excursion measurement is performed in M-mode as the distance between end-inspiration and end-expiration. Three measures of both DTF and excursion will performed and the better will be kept.Measure: Change from baseline in diaphragm ultrasound thickness and excursion Time: Day of enrollement, day 14, day 21, day 28 and day 35 from initial admission in ICU
Description: Muscle ultrasound measurements will be performed using a linear probe with a transverse view. Thickness (cm) of vastus intermedius, rectus femori and tibialis anterior will be measured.Measure: Mean change from baseline in ultrasound muscle thickness Time: Day of enrollement, day 14, day 21, day 28 and day 35 from initial admission in ICU
Description: Muscle ultrasound measurements will be performed using a linear probe with a transverse view. Cross-sectionnal area (CSA) (cm^2) of rectus femori and tibialis anterior will be measured.Measure: Mean change from baseline in ultrasound muscle cross-sectionnal area Time: Day of enrollement, day 14, day 21, day 28 and day 35 from initial admission in ICU
Description: Muscle ultrasound measurements will be performed using a linear probe with a transverse view. Echogeneicity (0 to 255) of rectus femori and tibialis anterior will be measured using Image J software. Penation angle of rectus femori will be assessed. is used to measure muscle thicknesses, CSA and echogeneicity. Longitudinal view is used to measure angle of pennation.Measure: Mean change from baseline in ultrasound muscle echogeneicity Time: Day of enrollement, day 14, day 21, day 28 and day 35 from initial admission in ICU
Description: Muscle ultrasound measurements will be performed using a linear probe with a longitudinal view. Penation angle (°) of rectus femori will be assessed.Measure: Mean change from baseline in ultrasound muscle pennation Time: Day of enrollement, day 14, day 21, day 28 and day 35 from initial admission in ICU
Description: MRC sum score evaluates strength in three muscle groups of all four limbs. A score between 0 and 5 is assigned to each of them, which renders a maximum total score of 60.Measure: Mean change from baseline in Medical Research Council (MRC) sum score Time: Day of enrollement, day 14, day 21, day 28 and day 35 from initial admission in ICU
Description: Number of adverse outcomes during early mobilization of patients will recorded at each mobilization session. Prevalence of adverse outcomes is expressed as the number of adverse outcomes divided by the number of early mobilization sessions.Measure: Prevalence of adverse outcomes during early mobilization Time: From date of enrollement up to 30 days (date of estimated post-ICU discharge)
In light of the ongoing COVID-19 epidemic in Norway, it is paramount to develop and utilize clinical tools for assessing and risk stratifying patients with suspected coronary infection in the emergency departments. Diagnostic use of ultrasound in viral pneumonias, including COVID-19 has proved to be very useful. The use of ultrasound will assist in quick detection of lung pathology compatible with increasing severity of the COVID-19 disease. At the same time, the use of ultrasound diagnostics in the emergency department could improve logistics and reduce potential exposure of the corona virus to other health personnel. The purpose of the study is to assess whether ultrasound findings correlates with physical examination, labs, and other imaging diagnostics in patients with suspected or diagnosed COVID-19 disease, as well as assessing whether ultrasound diagnostics can assist in risk stratification. The project is conducted as a prospective multicenter study where ultrasound diagnostics will be performed on patients with suspected coronary infection in the emergency departments. Data collection takes place as part of the daily clinical evaluation of acute patients in the emergency departments. The project is planned to be completed towards the end of 2025.
Description: 30-day mortalityMeasure: Mortality Time: up to 30 days
Description: In-hospital treatment level, e.g. discharge from ED, observational unit, ward, ICU.Measure: Level-of-care Time: up to 7 days
Description: in daysMeasure: In-hospital length of stay Time: Up to 30 days
Description: in hoursMeasure: Emergency department length of stay Time: Within 24 hours
Description: Clinical correlation between ultrasound findings and vital signs, labs, blood gas and other diagnostic modalities.Measure: Clinical correlation Time: Within 3 days