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.
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.
Croatia1 site
CHC Rijeka
Rijeka
Ivan Vuksan, M.D., +385998855042, ivuks16@gmail.com
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
- 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.
- Conditions
- Acute Respiratory Insufficiency
- 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 group | Role | What they receive |
|---|---|---|
| Critically Ill ICU Patients with Acute Respiratory Insufficiency | Not 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.
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)
Need for mechanical ventilation
Measured: day 14
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.
- First posted3 Mar 2026
- Study start15 Mar 2026 (estimated)
- Primary completion15 Apr 2026 (estimated)
- Study completion15 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Center Rijeka
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan Vuksan, Clinical Hospital Center Rijeka
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Lung Ultrasound Protocols for Assessing Pulmonary Function in Intensive Care Patients With Respiratory Failure
- ClinicalTrials.gov ID
- NCT07446803
- Acronym / sponsor ID
- UMBPI / LUSPRO
- Conditions
- Acute Respiratory Insufficiency
- Keywords
- Intensive care unit, Acute respiratory failure, Lung ultrasound, Ultrasound protocol
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Clinical Hospital Center RijekaUniversity, hospital or other
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically Ill ICU Patients with Acute Respiratory Insufficiency | – | Diagnostic Test: Abbreviated Lung Ultrasound Protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- Adult patients aged ≥18 years
- Admitted to the Intensive Care Unit (ICU) Susak
- Diagnosed with acute respiratory insufficiency
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abbreviated Lung Ultrasound ProtocolThis 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. | Diagnostic test | Critically Ill ICU Patients with Acute Respiratory Insufficiency |
Primary outcome
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.
2 secondary outcomes
Need for mechanical ventilation
Time frame: day 14
In-hospital mortality
Time frame: day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.