Respiratory Tract InfectionsNCT04645030
The Value of Ultralow Dosis CT and Ultrasound in the Diagnosing of Pneumonia in the Emergency Department
An observational study of Respiratory Tract Infections, run by University of Southern Denmark at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Respiratory Tract Infections
- What is being tested?
- Ultra low-dose computer thermography and lung ultrasound
- How many people
- 411 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2021to 1 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Adult, Older adult
Study population: Adults admitted to the ED will be invited to participate in the study, if the physician, receiving the patient, suspects the patient has an infection (e.g. indication for blood culture) and if the physician suspects community-acquired pneumonia. The physician will base his/her suspicion on clinical symptoms such as cough, increased sputum production, chest tightness, dyspnea and fever > 38⁰C, and indication for chest x-ray.
Who may be able to join
- Admission to an emergency department in the study, with one of following symptoms: dyspnea, cough, expectoration.
- Indication for blood culture
- Indication for chest x-ray OR
- the treating physician suspects a pneumonia diagnosis after the first evaluation of the patient
Who cannot join
- Patients < 40 years old due to risk of cancer from the radiation
- If the attending physician considers that participation will delay a life-saving treatment or patient needs direct transfer to the intensive care unit.
- Admission within the last 14 days
- Verified COVID-19 disease within 14 days before admission
- Pregnant women
- Severe immunodeficiencies: Primary immunodeficiencies and secondary immunodeficiencies (HIV positive CD4 <200, Patients receiving immunosuppressive treatment (ATC L04A), Corticosteroid treatment (>20 mg/day prednisone or equivalent for >14 days within the last 30 days), Chemotherapy within 30 days)
- Patients < 65 who already participated once due to risk of cancer from the radiation
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 100,000 and 30-day mortality is 13%. In 2018, 29.5 per 100.000 people died of pneumonia. An increase from 27.7 per 100,000 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 43,5% (39,4-50,8) and a specificity of 93% (92.1-93.9) 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. 1.5 times greater than the radiation dose of a chest X-ray and approx. 1.5% 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 0.95-0.98 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 0.97. 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.
- Conditions
- Respiratory Tract Infections
- Being tested
- Ultra low-dose computer thermography, lung ultrasound
- Keywords
- Pneumonia, Ultrasound, Ultra low-dose CT
- Medical subject headings
- Respiratory Tract Infections, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra low-dose computer thermographyDiagnostic test
The ULD-CT scan will be executed according to a standardized predeveloped technical protocol. The technical protocol will differentiate between patients with BMI <25 and >25 to insure optimal ULD-CT image quality.
lung ultrasoundDiagnostic test
LUS will be performed by trained researchers. Before inclusion researchers preforming LUS scans, will undergo a training program and will complete 25 supervised LUS scans to be certified in LUS. At the end of the training program, researchers will be tested to insure proficiency in LUS.
LUS will be performed according to LUS protocol with seven scanning's zones on each side; 2 anterior, 2 lateral and 3 posterior.
| Study group | Role | What they receive |
|---|---|---|
| Patients suspected of pneumonia | Patients suspected for pneumonia after initial evaluation by the treating physician. Receives: Diagnostic Test: Ultra low-dose computer thermography; Diagnostic Test: lung ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic capabilities of Ultra low-dose computer thermography for pneumonia
True positive, true negative, false positive and false negative for ultra low-dose computer thermography for pneumonia.
Measured: Within 24 hours from hospital admission
Title Diagnostic capabilities of lung ultrasound for pneumonia
True positive, true negative, false positive and false negative for lunge ultrasound for pneumonia.
Measured: Within 24 hours from hospital admission
Secondary outcomes (1)
Diagnostic capabilities of chest x-ray for pneumonia
True positive, true negative, false positive and false negative for chest x-ray for pneumonia
Measured: Within 24 hours from hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start1 Mar 2021
- Primary completion28 Feb 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 411 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Backer Mogensen, Principal investigator, Institute for Regional Sundhedsforskning
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645030
- Sponsor's protocol ID
- SHS-ED-11b-2020
- Status last verified
- Sep 2022
- First submitted
- 19 Nov 2020
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sogaard M, Nielsen RB, Schonheyder HC, Norgaard M, Thomsen RW. Nationwide trends in pneumonia hospitalization rates and mortality, Denmark 1997-2011. Respir Med. 2014 Aug;108(8):1214-22. doi: 10.1016/j.rmed.2014.05.004. Epub 2014 May 20.
PubMed 24898129Eshwara VK, Mukhopadhyay C, Rello J. Community-acquired bacterial pneumonia in adults: An update. Indian J Med Res. 2020 Apr;151(4):287-302. doi: 10.4103/ijmr.IJMR_1678_19.
PubMed 32461392MacIntyre CR, Chughtai AA, Barnes M, Ridda I, Seale H, Toms R, Heywood A. The role of pneumonia and secondary bacterial infection in fatal and serious outcomes of pandemic influenza a(H1N1)pdm09. BMC Infect Dis. 2018 Dec 7;18(1):637. doi: 10.1186/s12879-018-3548-0.
PubMed 30526505Self WH, Courtney DM, McNaughton CD, Wunderink RG, Kline JA. High discordance of chest x-ray and computed tomography for detection of pulmonary opacities in ED patients: implications for diagnosing pneumonia. Am J Emerg Med. 2013 Feb;31(2):401-5. doi: 10.1016/j.ajem.2012.08.041. Epub 2012 Oct 18.
PubMed 23083885Hagaman JT, Rouan GW, Shipley RT, Panos RJ. Admission chest radiograph lacks sensitivity in the diagnosis of community-acquired pneumonia. Am J Med Sci. 2009 Apr;337(4):236-40. doi: 10.1097/MAJ.0b013e31818ad805.
PubMed 19365166Hayden GE, Wrenn KW. Chest radiograph vs. computed tomography scan in the evaluation for pneumonia. J Emerg Med. 2009 Apr;36(3):266-70. doi: 10.1016/j.jemermed.2007.11.042. Epub 2008 Jun 20.
PubMed 18571356Claessens YE, Debray MP, Tubach F, Brun AL, Rammaert B, Hausfater P, Naccache JM, Ray P, Choquet C, Carette MF, Mayaud C, Leport C, Duval X. Early Chest Computed Tomography Scan to Assist Diagnosis and Guide Treatment Decision for Suspected Community-acquired Pneumonia. Am J Respir Crit Care Med. 2015 Oct 15;192(8):974-82. doi: 10.1164/rccm.201501-0017OC.
PubMed 26168322Brenner DJ, Hall EJ. Computed tomography--an increasing source of radiation exposure. N Engl J Med. 2007 Nov 29;357(22):2277-84. doi: 10.1056/NEJMra072149. No abstract available.
PubMed 18046031Mayo-Smith WW, Hara AK, Mahesh M, Sahani DV, Pavlicek W. How I do it: managing radiation dose in CT. Radiology. 2014 Dec;273(3):657-72. doi: 10.1148/radiol.14132328.
PubMed 25420167Kroft LJM, van der Velden L, Giron IH, Roelofs JJH, de Roos A, Geleijns J. Added Value of Ultra-low-dose Computed Tomography, Dose Equivalent to Chest X-Ray Radiography, for Diagnosing Chest Pathology. J Thorac Imaging. 2019 May;34(3):179-186. doi: 10.1097/RTI.0000000000000404.
PubMed 30870305Macri F, Greffier J, Pereira F, Rosa AC, Khasanova E, Claret PG, Larbi A, Gualdi G, Beregi JP. Value of ultra-low-dose chest CT with iterative reconstruction for selected emergency room patients with acute dyspnea. Eur J Radiol. 2016 Sep;85(9):1637-44. doi: 10.1016/j.ejrad.2016.06.024. Epub 2016 Jul 1.
PubMed 27501900Alzahrani SA, Al-Salamah MA, Al-Madani WH, Elbarbary MA. Systematic review and meta-analysis for the use of ultrasound versus radiology in diagnosing of pneumonia. Crit Ultrasound J. 2017 Dec;9(1):6. doi: 10.1186/s13089-017-0059-y. Epub 2017 Feb 27.
PubMed 28244009Long L, Zhao HT, Zhang ZY, Wang GY, Zhao HL. Lung ultrasound for the diagnosis of pneumonia in adults: A meta-analysis. Medicine (Baltimore). 2017 Jan;96(3):e5713. doi: 10.1097/MD.0000000000005713.
PubMed 28099332Orso D, Guglielmo N, Copetti R. Lung ultrasound in diagnosing pneumonia in the emergency department: a systematic review and meta-analysis. Eur J Emerg Med. 2018 Oct;25(5):312-321. doi: 10.1097/MEJ.0000000000000517.
PubMed 29189351Lichtenstein DA. Lung ultrasound in the critically ill. Ann Intensive Care. 2014 Jan 9;4(1):1. doi: 10.1186/2110-5820-4-1.
PubMed 24401163
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Ultralow Dosis CT and Ultrasound in the Diagnosing of Pneumonia in the Emergency Department
- ClinicalTrials.gov ID
- NCT04645030
- Acronym / sponsor ID
- SHS-ED-11b-2020
- Conditions
- Respiratory Tract Infections
- Keywords
- Pneumonia, Ultrasound, Ultra low-dose CT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 411 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 25 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 100,000 and 30-day mortality is 13%. In 2018, 29.5 per 100.000 people died of pneumonia. An increase from 27.7 per 100,000 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 43,5% (39,4-50,8) and a specificity of 93% (92.1-93.9) 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. 1.5 times greater than the radiation dose of a chest X-ray and approx. 1.5% 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 0.95-0.98 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 0.97. 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients suspected of pneumonia | – | Diagnostic Test: Ultra low-dose computer thermography, Diagnostic Test: lung ultrasoundPatients suspected for pneumonia after initial evaluation by the treating physician. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults admitted to the ED will be invited to participate in the study, if the physician, receiving the patient, suspects the patient has an infection (e.g. indication for blood culture) and if the physician suspects community-acquired pneumonia. The physician will base his/her suspicion on clinical symptoms such as cough, increased sputum production, chest tightness, dyspnea and fever > 38⁰C, and indication for chest x-ray.
Key inclusion criteria (4 listed)
- Admission to an emergency department in the study, with one of following symptoms: dyspnea, cough, expectoration.
- Indication for blood culture
- Indication for chest x-ray OR
- the treating physician suspects a pneumonia diagnosis after the first evaluation of the patient
Key exclusion criteria (7 listed)
- Patients < 40 years old due to risk of cancer from the radiation
- If the attending physician considers that participation will delay a life-saving treatment or patient needs direct transfer to the intensive care unit.
- Admission within the last 14 days
- Verified COVID-19 disease within 14 days before admission
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultra low-dose computer thermographyThe ULD-CT scan will be executed according to a standardized predeveloped technical protocol. The technical protocol will differentiate between patients with BMI <25 and >25 to insure optimal ULD-CT image quality. | Diagnostic test | Patients suspected of pneumonia |
| lung ultrasoundLUS will be performed by trained researchers. Before inclusion researchers preforming LUS scans, will undergo a training program and will complete 25 supervised LUS scans to be certified in LUS. At the end of the training program, researchers will be tested to insure proficiency in LUS. LUS will be performed according to LUS protocol with seven scanning's zones on each side; 2 anterior, 2 lateral and 3 posterior. | Diagnostic test | Patients suspected of pneumonia |
Primary outcome
Diagnostic capabilities of Ultra low-dose computer thermography for pneumonia
Time frame: Within 24 hours from hospital admission
True positive, true negative, false positive and false negative for ultra low-dose computer thermography for pneumonia.
Title Diagnostic capabilities of lung ultrasound for pneumonia
Time frame: Within 24 hours from hospital admission
True positive, true negative, false positive and false negative for lunge ultrasound for pneumonia.
1 secondary outcome
Diagnostic capabilities of chest x-ray for pneumonia
Time frame: Within 24 hours from hospital admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Background: PubMed 24898129Sogaard M, Nielsen RB, Schonheyder HC, Norgaard M, Thomsen RW. Nationwide trends in pneumonia hospitalization rates and mortality, Denmark 1997-2011. Respir Med. 2014 Aug;108(8):1214-22. doi: 10.1016/j.rmed.2014.05.004. Epub 2014 May 20.
- Background: PubMed 32461392Eshwara VK, Mukhopadhyay C, Rello J. Community-acquired bacterial pneumonia in adults: An update. Indian J Med Res. 2020 Apr;151(4):287-302. doi: 10.4103/ijmr.IJMR_1678_19.
- Background: PubMed 30526505MacIntyre CR, Chughtai AA, Barnes M, Ridda I, Seale H, Toms R, Heywood A. The role of pneumonia and secondary bacterial infection in fatal and serious outcomes of pandemic influenza a(H1N1)pdm09. BMC Infect Dis. 2018 Dec 7;18(1):637. doi: 10.1186/s12879-018-3548-0.
- Background: PubMed 23083885Self WH, Courtney DM, McNaughton CD, Wunderink RG, Kline JA. High discordance of chest x-ray and computed tomography for detection of pulmonary opacities in ED patients: implications for diagnosing pneumonia. Am J Emerg Med. 2013 Feb;31(2):401-5. doi: 10.1016/j.ajem.2012.08.041. Epub 2012 Oct 18.
- Background: PubMed 19365166Hagaman JT, Rouan GW, Shipley RT, Panos RJ. Admission chest radiograph lacks sensitivity in the diagnosis of community-acquired pneumonia. Am J Med Sci. 2009 Apr;337(4):236-40. doi: 10.1097/MAJ.0b013e31818ad805.
- Background: PubMed 18571356Hayden GE, Wrenn KW. Chest radiograph vs. computed tomography scan in the evaluation for pneumonia. J Emerg Med. 2009 Apr;36(3):266-70. doi: 10.1016/j.jemermed.2007.11.042. Epub 2008 Jun 20.
- Background: PubMed 26168322Claessens YE, Debray MP, Tubach F, Brun AL, Rammaert B, Hausfater P, Naccache JM, Ray P, Choquet C, Carette MF, Mayaud C, Leport C, Duval X. Early Chest Computed Tomography Scan to Assist Diagnosis and Guide Treatment Decision for Suspected Community-acquired Pneumonia. Am J Respir Crit Care Med. 2015 Oct 15;192(8):974-82. doi: 10.1164/rccm.201501-0017OC.
- Background: PubMed 18046031Brenner DJ, Hall EJ. Computed tomography--an increasing source of radiation exposure. N Engl J Med. 2007 Nov 29;357(22):2277-84. doi: 10.1056/NEJMra072149. No abstract available.
- Background: PubMed 25420167Mayo-Smith WW, Hara AK, Mahesh M, Sahani DV, Pavlicek W. How I do it: managing radiation dose in CT. Radiology. 2014 Dec;273(3):657-72. doi: 10.1148/radiol.14132328.
- Background: PubMed 30870305Kroft LJM, van der Velden L, Giron IH, Roelofs JJH, de Roos A, Geleijns J. Added Value of Ultra-low-dose Computed Tomography, Dose Equivalent to Chest X-Ray Radiography, for Diagnosing Chest Pathology. J Thorac Imaging. 2019 May;34(3):179-186. doi: 10.1097/RTI.0000000000000404.
- Background: PubMed 27501900Macri F, Greffier J, Pereira F, Rosa AC, Khasanova E, Claret PG, Larbi A, Gualdi G, Beregi JP. Value of ultra-low-dose chest CT with iterative reconstruction for selected emergency room patients with acute dyspnea. Eur J Radiol. 2016 Sep;85(9):1637-44. doi: 10.1016/j.ejrad.2016.06.024. Epub 2016 Jul 1.
- Background: PubMed 28244009Alzahrani SA, Al-Salamah MA, Al-Madani WH, Elbarbary MA. Systematic review and meta-analysis for the use of ultrasound versus radiology in diagnosing of pneumonia. Crit Ultrasound J. 2017 Dec;9(1):6. doi: 10.1186/s13089-017-0059-y. Epub 2017 Feb 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Backer Mogensen principal investigator
Institute for Regional Sundhedsforskning
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Tract Infections, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic capabilities of Ultra low-dose computer thermography for pneumonia (time frame: Within 24 hours from hospital admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04645030, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.