of Lung Ultrasound in Diagnosis of Acute Respiratory Distress SyndromeNCT05886556
Validity of Lung Ultrasound in Diagnosis of Acute Respiratory Distress Syndrome
An observational study of of Lung Ultrasound in Diagnosis of Acute Respiratory Distress Syndrome, run by Zagazig University at 1 site in Egypt.
Trial summary
To evaluate the validity of lung ultrasound compared to CT chest and chest radiograph for diagnosis of ARDS and prediction of successful weaning from mechanical ventilation in those patients compared to traditional methods. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- of Lung Ultrasound in Diagnosis of Acute Respiratory Distress Syndrome
- How many people
- 57 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients highly suspected to be ARDS admitted to ICU
Who may be able to join
- Patients or legal guardian's consent .All patients with suspicious criteria of acute respiratory distress syndrome .Hemodynamically stable in the absence or minimal of vasopressors.
Who cannot join
- Pregnant women. patients with traumatic lung injury or pneumothorax. surgical dressings over the right lower rib cage which would preclude ultrasound examination. presence of ascites. presence of lung collapse, fibrosis, or pleural effusion.
- -presence of any mass or mechanical factor in the chest or the abdomen interfering with the diaphragmatic mobility.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine,Zagazig University
Zagazig, Sharqia Province, 44519
marwa m medhat, MD, 01002828937
About this study
Official title: Validity of Lung Ultrasound in Diagnosis of Acute Respiratory Distress Syndrome and Prediction of Successful Weaning From Mechanical Ventilation in Those Patients
To evaluate the validity of lung ultrasound compared to CT chest and chest radiograph for diagnosis of ARDS and prediction of successful weaning from mechanical ventilation in those patients compared to traditional methods.
Read the detailed description
57 patients will be diagnosed as ARDS by CT chest and clinical criteria, then will be compared between the findings by lung ultrasound and chest radiograph to detect the sensitivity of both imaging to CT chest as gold standard in diagnosis of ARDS patients
- Keywords
- lung ultrasound, acute respiratory distress syndrome
- Medical subject headings
- Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic data checklist
Data of CT chest ,lung ultrasound and chest radiography in diagnosis of ARDS .
Measured: immediately after ICU admission
Secondary outcomes (3)
success rate
compared the success of both methods in terms of reintubation or not for those patients
Measured: within 24 hours after weaning
lung ultrasound as a predictor for weaning
evaluate the scoring of lung aeration
Measured: immediately before weaning
diaphragmatic ultrasound as a predictor for weaning
diaphragmatic thickness and excursion
Measured: immediately before weaning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start1 Jun 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for of Lung Ultrasound in Diagnosis of Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marwa Mohamed Medhat, Zagazig University
- Investigators
- mona elharisy, M.D, Study director, zagazig university faculty of human medicineMarwa M Medhat, M.D, Principal investigator, zagazig university faculty of human medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05886556
- Sponsor's protocol ID
- 8053
- Status last verified
- Jun 2023
- First submitted
- 23 May 2023
- Last updated
- 26 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of Lung Ultrasound in Diagnosis of Acute Respiratory Distress Syndrome and Prediction of Successful Weaning From Mechanical Ventilation in Those Patients
- ClinicalTrials.gov ID
- NCT05886556
- Acronym / sponsor ID
- 8053
- Keywords
- lung ultrasound, acute respiratory distress syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 2 Jun 2023 (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.
To evaluate the validity of lung ultrasound compared to CT chest and chest radiograph for diagnosis of ARDS and prediction of successful weaning from mechanical ventilation in those patients compared to traditional methods.
Detailed description
57 patients will be diagnosed as ARDS by CT chest and clinical criteria, then will be compared between the findings by lung ultrasound and chest radiograph to detect the sensitivity of both imaging to CT chest as gold standard in diagnosis of ARDS patients
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients highly suspected to be ARDS admitted to ICU
Key inclusion criteria (1 listed)
- Patients or legal guardian's consent .All patients with suspicious criteria of acute respiratory distress syndrome .Hemodynamically stable in the absence or minimal of vasopressors.
Key exclusion criteria (2 listed)
- Pregnant women. patients with traumatic lung injury or pneumothorax. surgical dressings over the right lower rib cage which would preclude ultrasound examination. presence of ascites. presence of lung collapse, fibrosis, or pleural effusion.
- -presence of any mass or mechanical factor in the chest or the abdomen interfering with the diaphragmatic mobility.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
diagnostic data checklist
Time frame: immediately after ICU admission
Data of CT chest ,lung ultrasound and chest radiography in diagnosis of ARDS .
3 secondary outcomes
success rate
Time frame: within 24 hours after weaning
lung ultrasound as a predictor for weaning
Time frame: immediately before weaning
diaphragmatic ultrasound as a predictor for weaning
Time frame: immediately before weaning
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
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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. This study is not recruiting at the moment.
mona elharisy, M.D study director
zagazig university faculty of human medicine
Marwa M Medhat, M.D principal investigator
zagazig university faculty of human medicine
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 of Lung Ultrasound in Diagnosis of Acute Respiratory Distress Syndrome, run by Zagazig 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 26 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marwa M Medhat, M.D (0552330832, Medhatmarwa9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic data checklist (time frame: immediately 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 26 Jun 2023.