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Acute Respiratory InsufficiencyUMBPINCT07446803

Ultrasound Scoring Methods to Monitor Breathing Problems in Intensive Care Patients

An observational study of Acute Respiratory Insufficiency, run by Clinical Hospital Center Rijeka at 1 site in Croatia.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Respiratory Insufficiency
What is being tested?
Abbreviated Lung Ultrasound Protocol
How many people
20 participants
Where
1 siteCroatia
Study dates
15 Mar 2026to 15 Apr 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ivan Vuksan, M.D. contact

+385998855042

ivuks16@gmail.com

Croatia1 site
  • CHC Rijeka

    Rijeka

    Ivan Vuksan, M.D., +385998855042, ivuks16@gmail.com

Other trials in Croatia

About this study

Official title: Comparison of Lung Ultrasound Protocols for Assessing Pulmonary Function in Intensive Care Patients With Respiratory Failure

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:

Read more
  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

Read the detailed description

Lung ultrasound (LUS) has gained significant clinical importance in intensive care settings over the past two decades. Unlike other radiological examinations, LUS offers several advantages: it is cost-effective, does not utilize ionizing radiation, enables repeated examination without harmful consequences, and is portable for bedside assessment in real-time. LUS is superior to chest radiography in detecting pleural effusions smaller than 500 mL and demonstrates comparable sensitivity and specificity to computed tomography for diagnosing pathological changes such as pleural effusions, pneumothorax, pneumonia, and pulmonary edema. However, the main limitation of LUS is its operator-dependent nature. Skill and experience significantly influence examination quality, though this limitation can be overcome through practice and standardization. The Baciarello protocol, developed during the 2020 COVID-19 pandemic, divides each hemithorax into 6 fields: anterior (ventral to anterior axillary line), middle (between anterior and posterior axillary lines), and posterior (dorsal to posterior axillary line), with each region further divided horizontally through the xiphoid process. All 12 fields are scored 0-3 points based on ultrasound findings: 0 points (A-lines with pleural sliding or fewer than three B-lines), 1 point (three or more well-distributed B-lines with pleural sliding), 2 points (confluent B-lines or light beam phenomenon), 3 points (pulmonary consolidations including subpleural consolidations). Total scores range from 0-36. Studies showed that patients with total scores ≥12 demonstrated greater need for ICU admission and invasive mechanical ventilation, while scores ≥18 were associated with higher in-hospital mortality. The new abbreviated local protocol reduces examination points to 6 fields (3 per hemithorax) assessed at the level of the nipple or fourth intercostal space in the medioclavicular line, extending horizontally toward the dorsal aspect. Scoring criteria remain identical to the Baciarello protocol, but total scores range from 0-18. Preliminary thresholds suggest scores ≥6 indicate need for non-invasive or invasive mechanical ventilation, while scores ≥9 suggest high in-hospital mortality. Recent studies comparing different LUS protocols with varying numbers of examination points have demonstrated that abbreviated protocols reduce examination duration while maintaining diagnostic accuracy. Research comparing 6-, 8-, and 12-point protocols in COVID-19 patients emphasized examination time efficiency (3 minutes for 6-point protocols versus up to 10 minutes for 12-point protocols) while maintaining clinical utility in emergency settings. A 6-point protocol was found to enable efficient, rapid assessment of lung pathology. However, some studies note that the 8-point protocol's omission of dorsal lung regions-where lung pathology is most common-represents a potential limitation. The 12-point protocol is credited with highest specificity in lung pathology assessment but requires longer examination duration. This study was designed to determine whether the abbreviated 6-point local protocol provides equivalent statistical and clinical information to the established 12-point Baciarello protocol. This comparison is clinically significant given healthcare system strain, staff shortages, and the need for rapid bedside assessment in critically ill patients with acute respiratory insufficiency. If no statistically significant difference exists between protocols, the shorter examination could simplify clinical application of LUS as a diagnostic and prognostic tool in intensive care practice.

Being tested
Abbreviated Lung Ultrasound Protocol
Keywords
Intensive care unit, Acute respiratory failure, Lung ultrasound, Ultrasound protocol

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abbreviated Lung Ultrasound ProtocolDiagnostic 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.

Study groups in NCT07446803
Study groupRoleWhat they receive
Critically Ill ICU Patients with Acute Respiratory InsufficiencyNot described
Receives: Diagnostic Test: Abbreviated Lung Ultrasound Protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Assessments will be conducted upon or shortly after ICU admission.

Secondary outcomes (2)
  1. Need for mechanical ventilation

    Measured: day 14

  2. In-hospital mortality

    Measured: day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2026
  2. Study start15 Mar 2026 (estimated)
  3. Primary completion15 Apr 2026 (estimated)
  4. Study completion15 Apr 2026 (estimated)

Resources

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
Prospective
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07446803
Sponsor's protocol ID
LUSPRO
Acronym
UMBPI
Status last verified
Feb 2026
First submitted
24 Feb 2026
Last updated
3 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Respiratory Insufficiency, run by Clinical Hospital Center Rijeka at 1 site in Croatia.

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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 3 Mar 2026. 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 Croatia. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ivan Vuksan, M.D. (+385998855042, ivuks16@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Equivalence of 6-point abbreviated and 12-point Baciarello lung ultrasound protocols in assessing lung function (time frame: Assessments will be conducted upon or shortly after ICU admission.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 3 Mar 2026.

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