CRP and Lung Ultrasound in Respiratory Evaluation

NCT06294899 | Not Yet Recruiting

• 1 other identifier: 23/222-P
• Study Type: observational
• Target: 202
• Locations: 0 countries
• Sites: N/A

Brief Summary

Lower respiratory tract infections (LRTIs) are one of the most common reasons for consultation in Primary Care centres. Differentiating between viral and bacterial aetiologies can be challenging, leading to inappropriate antibiotic prescribing. Lung ultrasound (LUS), an imaging test that gained particular relevance since the beginning of the SARS-CoV-2 pandemic, offers several advantages over the classic chest X-ray in detecting and monitoring LRTIs, especially when pleural involvement exists. This study aims to correlate LUS findings with capillary blood C-Reactive Protein (CRP) values in patients with LRTIs, evaluating LUS as a diagnostic tool and its impact on therapeutic decisions. The descriptive observational study, conducted from January 2024 to December 2026 in Lleida, will include LRTI patients attending Primary Care centres. By validating LUS as a rapid and non-invasive diagnostic tool, unnecessary antibiotic prescriptions can be reduced, promoting LUS as a complementary test in Primary Care consultations. This will facilitate appropriate diagnosis and treatment decisions for patients with LRTIs, enhancing the overall management of respiratory infections.

Conditions

Primary Health Care; Lower Respiratory Tract Infection

Keywords

C-Reactive Protein; Lung ultrasonography; Lower Respiratory Tract Infections

Outcome Measures

Primary Outcomes (2)

• Ultrasound patterns

  Standardized criteria will be used to differentiate between normal patterns and those that may indicate pathological conditions. The classification of patterns will include, but not be limited to, tissue heterogeneity, presence of masses or fluids, and characteristics of the edges of lesions.

  Each evaluation will be carried out during a dedicated ultrasound session, with an approximate duration of 15 minutes per participant.

• C-Reactive Protein

  This metric assesses the levels of C-Reactive Protein in the blood, an indicator of inflammation in lower respiratory tract infections already used in the Primary Care practice.

  CRP levels will be measured at baseline.

Interventions

Lung ultrasound DIAGNOSTIC_TEST

Lung ultrasound will be performed to patients with suspected lower respiratory tract infections.

C-Reactive Protein Test DIAGNOSTIC_TEST

C-Reactive Protein Test will be performed to patients with suspected lower respiratory tract infections.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with lower respiratory tract infections attending Primary Care centres in Lleida.

You may qualify if:

• Age ≥ 18 years old
• Clinical suspicion of LRTI defined as acute illness lasting less than 21 days, with cough as the main symptom, accompanied by at least one other lower respiratory symptom (such as sputum production, dyspnoea, difficult breathing, or chest pain) without any other explanation for the clinical picture.
• Ability to read, understand and willingness to give written consent to participate in the study.

You may not qualify if:

• Patients with hemodynamic instability or that need emergency medical care due to the current clinical condition.
• Previous diagnosis of lung or pleural cancer.
• Thoracic surgery within the past 60 days.
• Lung interstitial diseases.
• Patients who refuse to participate in the study

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead

Central Study Contacts

Anna Llinas Vaquer

CONTACT

692473511; allinas.lleida.ics@gencat.cat

Delegado de Protección de Datos

CONTACT

dpd@ticsalutsocial.cat

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 6, 2024
• Study Start: June 1, 2024
• Primary Completion: May 30, 2025
• Study Completion (Estimated): September 1, 2028
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share