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Acute Respiratory Distress SyndromeNCT06971042

Early Diagnosis of ARDS in Mechanically Ventilated Patient Using LUS Score in Comparison With CT

An observational study of Acute Respiratory Distress Syndrome and Mechanical Ventilation Complication, run by Tanta University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The aim of this study is to assess accuracy of Lung ultrasound score for early diagnosis of acute respiratory distress syndrome in patients who expected to be mechanically ventilated more than 24 hour in comparison with computed tomography chest . Read more about this study

Who is it for?
Ages 22 to 80 years
What is being tested?
Lung Ultrasound
Type of treatment
Surgery or procedure
How many people
20 participants
Where
1 siteEgypt
Study dates
10 Aug 2024to 20 Aug 2025
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 22 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: patients admitted in surgical Intensive care unit that mechanically ventilated more than 24 hours who fulfill criteria of Acute Respiratory Distress Syndrome according to Berlin definition.

Who may be able to join

  • Patients aged more than 21 years old of both sexes .
  • Patients who are expected to be mechanically ventilated more than 24 h .
  • Patients who are suspected to be Acute Respiratory Distress Syndrome according to Berlin definition which consists of clinical criteria and with precipitating factors which starts within 1 week of known insult as in trauma patients with lung contusions.

Who cannot join

  • Patient's first guardian who refuse the inclusion in the study .
  • History of pre-existing lung disease ( tumors, interstitial lung diseases)
  • In cases of volume overload.
  • Patients with acute kidney injuiry or renal failure

Trial locations and contacts

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

Roaa Elshamy, MSc contact

01275530586 ext. +2

r1shamy@yahoo.com

Egypt1 site, 1 recruiting
  • Tanta university

    Tanta, 31527

    Roaa Elshamy, MSc, 01275530586 ext. +2, r1shamy@yahoo.com

    Recruiting

Other trials in Egypt

About this study

Official title: Early Diagnosis of Acute Respiratory Distress Syndrome (ARDS) in Mechanically Ventilated Patient Using Lung Ultrasound Score in Comparison With CT Chest

The aim of this study is to assess accuracy of Lung ultrasound score for early diagnosis of acute respiratory distress syndrome in patients who expected to be mechanically ventilated more than 24 hour in comparison with computed tomography chest .

Read the detailed description

Acute respiratory distress syndrome is an acute, diffuse, inflammatory form of lung injury and life-threatening condition in seriously ill patients, characterized by poor oxygenation, pulmonary infiltrates, and acute onset. on a microscopic level, the disorder is associated with capillary endothelial injury and diffuse alveolar damage Acute respiratory distress syndrome is an acute disorder that starts within seven days of the inciting event and is characterized by bilateral lung infiltrates and severe progressive hypoxemia in the absence of any evidence of cardiogenic pulmonary edema. According to the Berlin definition, Acute respiratory distress syndrome is defined by acute onset, bilateral lung infiltrates on chest radiography or computed tomography scan of a non-cardiac origin, and a PaO2/FiO2 ratio of less than 300 mm Hg. The Berlin definition differs from the previous American-European Consensus definition by excluding the term acute lung injury; it also removed the requirement for wedge pressure < 18 mm Hg and included the requirement of positive end-expiratory pressure or continuous positive airway pressure of greater than or equal to 5 cm H20.

Once Acute respiratory distress syndrome develops, patients usually have varying degrees of pulmonary artery vasoconstriction and may subsequently develop pulmonary hypertension. Acute respiratory distress syndrome carries a high mortality, and few effective therapeutic modalities exist to combat this condition Although the Berlin definition of Acute respiratory distress syndrome was a major step forward, some of its limitations were recognized soon after publication. Specifically, it was recognized that its requirement for noninvasive ventilation or invasive ventilation could not be met in settings in which these modalities are not available So consensus conference of 32 critical care develop new global Acute respiratory distress syndrome definition that use high flow nasal oxygen , pulse oximetry in place of arterial blood gas and use of Lung ultrasound to suit limited resource setting .

Lung computed tomography scan is the gold standard in diagnosis of Acute respiratory distress syndrome can provide useful diagnostic information and assess the benefit of treatment. However, this procedure is done in a computed tomography unit under cardiorespiratory monitoring with an increased risk to the patient.

Diagnostic and lung exploratory ultrasound is a rapidly evolving technique used in the Intensive care unit environment, being considered noninvasive, radiation-free, cheap, and easy to perform .

Lung ultrasound has been validated for hemodynamic management, pleural effusions, pulmonary edema, pneumothorax detection, parenchymal consolidation, and central vein catheter placement .

simple and short Lung ultrasound examination could predict prone position oxygenation response in Acute respiratory distress syndrome patients .

Scores based on detection of B-lines (the sonographic sign of increased lung density associated with interstitial syndrome) and on consolidation have been correlated with global and regional lung aeration as assessed by computed tomography chest.

Lung ultrasound has been proposed as an accurate bedside and radiation free technique for evaluation of lung consolidations and for follow-up of aeration changes in response to interventions.

However lung us scoring system hasn't been included in Acute respiratory distress syndrome definition and didn't prefer image modality in diagnosis of Acute respiratory distress syndrome , therefore our study will explore the feasibility and accuracy of lung us score performed bedside to differentiate between Acute respiratory distress syndrome and non Acute respiratory distress syndrome patient compared to lung computed tomography .

Being tested
Lung Ultrasound
Medical subject headings
Respiratory Distress Syndrome

What participants receive

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

  • Lung UltrasoundRadiation

    Also called Lung computed tomography

    Patients were examined in supine position, using a portable ultrasound machine equipped with a curvilinear transducer (5-3 MHz)

What is being measured

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

  1. Diagnosis of Acute respiratory distress syndrome

    Accuracy of lung ultrasound score in diagnosis of Acute respiratory distress syndrome in comparison with Lung computed tomography .

    Measured: Within 48 hours

Secondary outcomes (1)
  1. Severity of Acute respiratory distress syndrome .

    Accuracy of lung ultrasound score in assessment severity of Acute respiratory distress syndrome .

    Measured: Within 48 hours

Timeline

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

  1. First posted14 May 2025
  2. Study start10 Aug 2024
  3. Primary completion20 Aug 2025 (estimated)
  4. Study completion20 Aug 2025 (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
NCT06971042
Sponsor's protocol ID
36264MS675/8/24
Status last verified
Jun 2025
First submitted
6 May 2025
Last updated
29 Jun 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The data will be available upon the reasonable request from the principle

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Respiratory Distress Syndrome and Mechanical Ventilation Complication, run by Tanta University at 1 site in Egypt.

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: looking for participants now, as of the sponsor's last update on 29 Jun 2025. 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 Egypt. 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 Roaa Elshamy, MSc (01275530586 ext. +2, r1shamy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnosis of Acute respiratory distress syndrome (time frame: Within 48 hours). 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 29 Jun 2025.

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