Ultrasound Scoring Methods to Monitor Breathing Problems in Intensive Care Patients

NCT07446803 | Not Yet Recruiting

• 1 other identifier: LUSPRO
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to compare two lung ultrasound protocols for assessing lung function in patients with acute respiratory insufficiency treated in intensive care units. The main questions it aims to answer are: 1\. Is there a statistically significant difference between the established Baciarello (name of author) ultrasound protocol (12-point examination) and a new, abbreviated local ultrasound protocol (6-point examination) for assessing lung function? 2. Do the scoring systems of both protocols correlate with each other and with treatment outcomes in critically ill patients? Researchers will compare the Baciarello protocol (assessing 12 fields-6 per side of the body to a new abbreviated local protocol (assessing 6 fields-3 per side of the body) to see if both protocols provide same diagnostic and prognostic information for evaluating lung pathology and patient outcomes. Participants will: Undergo lung ultrasound assessment using both protocols Have their ultrasound findings scored according to each protocol's point system (0-36 for Baciarello; 0-18 for the new abbreviated protocol) Have their arterial blood gas values recorded (pH, PaCO2, PaO2, oxygen saturation) Be monitored for clinical outcomes including mechanical ventilation requirements and hospital mortality

Conditions

Acute Respiratory Insufficiency

Keywords

Intensive care unit; Acute respiratory failure; Lung ultrasound; Ultrasound protocol

Outcome Measures

Primary Outcomes (1)

• Equivalence of 6-point abbreviated and 12-point Baciarello lung ultrasound protocols in assessing lung function

  Assessments will be conducted upon or shortly after ICU admission.

Secondary Outcomes (2)

• Need for mechanical ventilation

  day 14

• In-hospital mortality

  day 28

Study Arms (1)

Critically Ill ICU Patients with Acute Respiratory Insufficiency

Diagnostic Test: Abbreviated Lung Ultrasound Protocol

Interventions

Abbreviated Lung Ultrasound Protocol DIAGNOSTIC_TEST

This intervention uses only 6 examination points (3 per hemithorax) compared to the established Baciarello protocol's 12 points. This represents a 50% reduction in examination sites while preserving comprehensive regional coverage. Standardised Anatomical Positioning Examination is performed at the level of the nipple or 4th intercostal space in the midclavicular line, then proceeds horizontally toward the posterior regions. This precise anatomical landmark standardises probe placement and differs from protocols using multiple horizontal levels. The protocol employs a 0-18 point scoring scale (0-3 points per field) versus the Baciarello protocol's 0-36 scale.

Critically Ill ICU Patients with Acute Respiratory Insufficiency

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 diagnosed with acute respiratory insufficiency requiring advanced respiratory support who are admitted to the Intensive Care Unit Susak will be enrolled in this prospective study.

You may qualify if:

• Adult patients aged ≥18 years
• Admitted to the Intensive Care Unit (ICU) Susak
• Diagnosed with acute respiratory insufficiency

You may not qualify if:

• Technical inability to perform a lung ultrasound due to patient positioning or other technical reasons
• Morbid obesity (BMI ≥40 kg/m²)
• Serious chest trauma that would compromise assessment
• Lung pathology that impairs ultrasound visualisation of the desired examination regions

Sponsors & Collaborators

• Clinical Hospital Center Rijeka: lead

Study Sites (1)

CHC Rijeka

Rijeka, Croatia

Location

Central Study Contacts

Ivan Vuksan, M.D.

CONTACT

+385998855042; ivuks16@gmail.com

Study Design

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

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 3, 2026
• Study Start: March 15, 2026
• Primary Completion: April 15, 2026
• Study Completion: April 15, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

CR (1)