The Value of Ultralow Dosis CT and Ultrasound in the Diagnosing of Pneumonia in the Emergency Department

NCT04645030 | Completed

• 1 other identifier: SHS-ED-11b-2020
• Study Type: observational
• Target: 411
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Tract Infections

Keywords

Pneumonia; Ultrasound; Ultra low-dose CT

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Within 24 hours from hospital admission

Secondary Outcomes (1)

• Diagnostic capabilities of chest x-ray for pneumonia

  Within 24 hours from hospital admission

Other Outcomes (2)

• CURB-65 score for pneumonia severity

  within 4 hours from admission

• PSI

  within 4 hours from admission

Study Arms (1)

Patients suspected of pneumonia

Patients suspected for pneumonia after initial evaluation by the treating physician.

Diagnostic Test: Ultra low-dose computer thermography; Diagnostic Test: lung ultrasound

Interventions

Ultra low-dose computer thermography DIAGNOSTIC_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.

Patients suspected of pneumonia

lung ultrasound DIAGNOSTIC_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.

Patients suspected of pneumonia

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

Hospital of Southern Jutland

Aabenraa, Denmark

Location

Related Publications (23)

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MeSH Terms

Conditions

Respiratory Tract Infections; Pneumonia

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Lung Diseases

Study Officials

• Christian Backer Mogensen

  Institute for Regional Sundhedsforskning

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: November 25, 2020
• Study Start: March 1, 2021
• Primary Completion: February 28, 2022
• Study Completion: June 1, 2022
• Last Updated: September 14, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)