Ultra-low Dose Chest Computed Tomography: a Rule-out Tool for Community-acquired Pneumonia

NCT ID: NCT04541160

Last Updated: 2020-09-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 237 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2018-12-01

Brief Summary

This is a randomized study that sought to compare the rule-out capacity and antibiotics prescriptions associated with two different diagnostic imaging strategies (ultra-low-dose chest computed tomography versus chest radiography) in a group of healthy adults presenting to the emergency department (ED) with suspected community-acquired pneumonia (CAP).

Detailed Description

Between October 2017 and December 2018, we prospectively enrolled consecutive adult patients with suspected community-acquired pneumonia based on at least one respiratory symptom and focal auscultatory findings and at least one sign related to infection, for whom no definitive diagnosis was possible by clinical judgment.

Eligible patients were randomly assigned to their imaging evaluation in a 1:1 ratio to either ultra-low-dose chest computed tomography (ULDCT) or the standard evaluation strategy using conventional chest radiography (CR).

This study sought to compare the rule-out capacity and antibiotics prescriptions associated with those two different diagnostic imaging strategies (ULDCT versus CR) in a group of healthy adult patients presenting to the ED with suspected CAP.

Conditions

Pneumonia; Diagnoses Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Suspected community-acquired pneumonia patients

Suspected community-acquired pneumonia patients that will be evaluated by an imaging method

CR

Intervention Type: DIAGNOSTIC_TEST

Lung imaging evaluation performed with CR

ULDCT

Intervention Type: DIAGNOSTIC_TEST

Lung imaging evaluation performed with ULDCT

Interventions

CR

Lung imaging evaluation performed with CR

Intervention Type: DIAGNOSTIC_TEST

ULDCT

Lung imaging evaluation performed with ULDCT

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Suspected CAP;
• At least one respiratory symptom (new or increasing cough, expectoration, dyspnea or chest pain) and
• At least one symptom related to infection (fever ≥ 38°C, chills, sweating, myalgia, mental confusion or headache) and
• Focal auscultatory findings during physical examinations (crackling rales)
• No definitive diagnosis possible by clinical judgment.

Exclusion Criteria

• Score in at least one clinical part of the CURB-65 or PSA scores
• Clinical diagnosis of rhinosinusitis and acute nasopharyngitis and who had already been treated with antimicrobial therapy for this episode of disease
• pregnancy;
• the presence of other respiratory diseases such as chronic obstructive pulmonary disease (COPD), asthma, interstitial lung disease, chronic diseases or other chronic airway conditions;
• diagnosis of congestive heart failure;
• body mass index (BMI) greater than 30;
• inability to hold the breath for at least 10 seconds

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

Hospital Israelita Albert Einstein

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Israelita Albert Einstein

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

3083

Identifier Type: -

Identifier Source: org_study_id