Ignite Creation Date:
2024-05-06 @ 3:29 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04645030
Status:
COMPLETED
Last Update Posted:
2022-09-14
First Post:
2020-11-19
Brief Title:
The Value of Ultralow Dosis CT and Ultrasound in the Diagnosing of Pneumonia in the Emergency Department
Sponsor:
University of Southern Denmark
Organization:
University of Southern Denmark
Study Overview
Official Title:
The Value of Ultralow Dosis CT and Ultrasound in the Diagnosing of Pneumonia in the Emergency Department
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pneumonia is one of the most common infections in the emergency department ED Nevertheless the current diagnostic tools are often slow and inaccurate Currently a chest x-ray is the first choice for diagnostic imaging for pneumonia in the ED but is inaccurate with low sensitivity and specificity resulting in both over-and underdiagnosing of pneumonia Alternatively computer thermography CT and high-resolution CT HR-CT offers high diagnostic accuracy but involves significantly increased radiation to the patient and increased costs and examination time Lately two alternatives to chest x-ray have emerged
The first is lung ultrasound LUS which has shown higher sensitivity and specificity for pneumonia than a chest x-ray when performed by experts However the diagnostic accuracy of lung ultrasound performed by novice operators in the ED still needs investigation
The second alternative to chest x-ray is ultra-low-dose CT ULD-CT A ULD-CT is a CT scan where the radiation dose is significantly reduced while still maintaining acceptable image quality In effect merging the high diagnostic accuracy of chest CT with the low radiation doses of chest X-ray
The aim of this study is to investigate the diagnostic accuracy of LUS by novice operators in the ED and the diagnostic accuracy of ULD-CT thorax in patients suspected of having pneumonia
The first is lung ultrasound LUS which has shown higher sensitivity and specificity for pneumonia than a chest x-ray when performed by experts However the diagnostic accuracy of lung ultrasound performed by novice operators in the ED still needs investigation
The second alternative to chest x-ray is ultra-low-dose CT ULD-CT A ULD-CT is a CT scan where the radiation dose is significantly reduced while still maintaining acceptable image quality In effect merging the high diagnostic accuracy of chest CT with the low radiation doses of chest X-ray
The aim of this study is to investigate the diagnostic accuracy of LUS by novice operators in the ED and the diagnostic accuracy of ULD-CT thorax in patients suspected of having pneumonia
Detailed Description:
Community-acquired pneumonia CAP is one of the most common infectious diseases in the emergency department ED In Denmark the incidence of hospitalization is 809 per 100000 and 30-day mortality is 13 In 2018 295 per 100000 people died of pneumonia An increase from 277 per 100000 in 2017 CAP is usually suspected in patients with dyspnea cough and fever without other probable explanations or when other differential diagnosis is less likely However often patients present with vague and uncharacteristic symptoms such as altered state of consciousness gastrointestinal symptoms or pain Likewise is fever not always present in the elderly The most common CAP pathogens are Streptococcus pneumoniae Haemophilus influenzae and gram-negative bacilli Other notable microbiological pathogens include viruses such as Influenza COVID-19 parainfluenza and respiratory syncytial virus Viruses are associated with bacterial co-infections leading to increase mortality and complications such as admission to the ICU Normally when a pulmonary infection is suspected a chest X-ray is performed Chest x-rays have a sensitivity of 435 394-508 and a specificity of 93 921-939 for pulmonary opacities compared to CT A chest x-ray has a sensitivity of 79 for pneumonia Computed tomography CT scan of the thorax has higher diagnostic precision and results improve management but result in a correspondingly increased amount of radiation compared to chest X-ray An ultra-low-dose CT ULD-CT scan of the thorax may be an alternative to CT scan ULD-CT has a radiation dose of approx 15 times greater than the radiation dose of a chest X-ray and approx 15 of a CT scan ULD-CT has shown better image quality than chest X-ray and for acutely admitted patients with dyspnea it has a clinical effect on both diagnosis and treatment Like chest X-rays basic findings on ULD-CT of the thorax can be interpreted by trained clinicians
Ultrasound is a fast non-invasive diagnostic test without radiation LUS has high sensitivity and specificity with the area under ROC AUC of 095-098 for pneumonia A meta-study for the use of LUS in the diagnosis of pneumonia in the ED has shown a sensitivity of 92 87-96 and a specificity of 94 87-97 AUC was calculated at 097 The ultrasound operators in the meta-study were all experienced ultrasound operators Ultrasound is an operator-dependent tool and in children it has been demonstrated that LUS diagnostic accuracy for pneumonia is significantly lower when performed by a novice sonographer compared to an advanced sonographer There are few if any studies that have investigated the diagnostic accuracy of novice LUS operator in the ED for pneumonia
Study goals and objectives The project is divided into two a ULD-CT study and an LUS study The study will aim to investigate their diagnostic capabilities in at emergency department setting
The main objective of the ULD-CT study is to investigate and answer
Can ULD-CT be used to diagnose pneumonia in the emergency department
How is the agreement between the results from ULD-CT and results from HR-CT
Is ULDCT more sensitive and specific than standard chest x-ray in the diagnosis of pneumonia
The investigators hypothesize that ULD-CT can be used in the evaluation of patients with pneumonia and the sensitivity specificity and area under the curve AUC of ULD-CT is higher than a chest x-ray The null-hypothesis is that ULD-CT is not an accurate diagnostic tool for pneumonia in the emergency department
The main objective of the LUS study is to investigate and answer
Can LUS be used to diagnose pneumonia in the emergency department with newly certified LUS operators
How is the agreement between the results from LUS and the results from HR-CT
Is LUS more sensitive and specific than standard chest x-ray in the diagnosis of pneumonia
The investigators hypothesize that LUS can be used in the evaluation of patients with pneumonia by recently certified operators and the sensitivity specificity and AUC of LUS is higher than chest x-ray in an emergency department setting The null-hypothesis is that LUS performed by recently certified operators is not an accurate diagnostic tool for pneumonia in the emergency department
Ultrasound is a fast non-invasive diagnostic test without radiation LUS has high sensitivity and specificity with the area under ROC AUC of 095-098 for pneumonia A meta-study for the use of LUS in the diagnosis of pneumonia in the ED has shown a sensitivity of 92 87-96 and a specificity of 94 87-97 AUC was calculated at 097 The ultrasound operators in the meta-study were all experienced ultrasound operators Ultrasound is an operator-dependent tool and in children it has been demonstrated that LUS diagnostic accuracy for pneumonia is significantly lower when performed by a novice sonographer compared to an advanced sonographer There are few if any studies that have investigated the diagnostic accuracy of novice LUS operator in the ED for pneumonia
Study goals and objectives The project is divided into two a ULD-CT study and an LUS study The study will aim to investigate their diagnostic capabilities in at emergency department setting
The main objective of the ULD-CT study is to investigate and answer
Can ULD-CT be used to diagnose pneumonia in the emergency department
How is the agreement between the results from ULD-CT and results from HR-CT
Is ULDCT more sensitive and specific than standard chest x-ray in the diagnosis of pneumonia
The investigators hypothesize that ULD-CT can be used in the evaluation of patients with pneumonia and the sensitivity specificity and area under the curve AUC of ULD-CT is higher than a chest x-ray The null-hypothesis is that ULD-CT is not an accurate diagnostic tool for pneumonia in the emergency department
The main objective of the LUS study is to investigate and answer
Can LUS be used to diagnose pneumonia in the emergency department with newly certified LUS operators
How is the agreement between the results from LUS and the results from HR-CT
Is LUS more sensitive and specific than standard chest x-ray in the diagnosis of pneumonia
The investigators hypothesize that LUS can be used in the evaluation of patients with pneumonia by recently certified operators and the sensitivity specificity and AUC of LUS is higher than chest x-ray in an emergency department setting The null-hypothesis is that LUS performed by recently certified operators is not an accurate diagnostic tool for pneumonia in the emergency department
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None