Detecting the Number of B-lines in Lung Ultrasound and Its Accuracy in Diagnosis of Weaning Induced Pulmonary OedemaNCT04463303
The Role of Lung Ultrasound in The Diagnosis of Weaning -Induced Pulmonary Edema
An observational study of Detecting the Number of B-lines in Lung Ultrasound and Its Accuracy in Diagnosis of Weaning Induced Pulmonary Oedema, run by Assiut University.
Trial summary
The aim of the work is to 1. Assess the incidence of weaning induced pulmonary adema(WIPO). 2. Assess the risk factors of WIPO. 3. Evaluate the role of lung ultrasound in detecting WIPO during spontenous breathing trial(SBT). 4. Read more about this study
- Who is it for?
- Ages Up to 60 years
- Conditions the study is for
- Detecting the Number of B-lines in Lung Ultrasound and Its Accuracy in Diagnosis of Weaning Induced Pulmonary Oedema
- What is being tested?
- lung ultrasound
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jul 2020to Jul 2021
- 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 Up to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study will include patients on mechanical ventilation who will be suitable for spontaneous breathing trial (SBT).
Who may be able to join
- The study will include patients on mechanical ventilation who will be suitable for spontaneous breathing trial (SBT).
Who cannot join
- Patients with poor lung ultrasound window, history of cardiomyopathy, significant valvular disease (aortic or mitral insufficiency of grade ≥ 2, mild or severe aortic and mitral stenosis) will be excluded from the study.
About this study
The aim of the work is to
- Assess the incidence of weaning induced pulmonary adema(WIPO).
- Assess the risk factors of WIPO.
- Evaluate the role of lung ultrasound in detecting WIPO during spontenous breathing trial(SBT).
- Detect the threshold of B-line increase (Delta-B-lines) that provided the best diagnostic accuracy of WIPO.
- Being tested
- lung ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung ultrasoundOther
patient with or without weaning induced pulmonary adema
| Study group | Role | What they receive |
|---|---|---|
| group 1 | patient who will develop weaning induced pulmonary adema Receives: Other: lung ultrasound | |
| group 2 | patient who will nor develop weaning induced pulmonary adema Receives: Other: lung ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of B-lines in lung ultrasound and its accuracy in diagnosis of weaning induced pulmonary oedema
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study startJul 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Detecting the Number of B-lines in Lung Ultrasound and Its Accuracy in Diagnosis of Weaning Induced Pulmonary OedemaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Ali Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463303
- Sponsor's protocol ID
- LULTRASOUND
- Status last verified
- Jul 2020
- First submitted
- 5 Jul 2020
- Last updated
- 9 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Lung Ultrasound in The Diagnosis of Weaning -Induced Pulmonary Edema
- ClinicalTrials.gov ID
- NCT04463303
- Acronym / sponsor ID
- LULTRASOUND
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 9 Jul 2020 (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 aim of the work is to
- Assess the incidence of weaning induced pulmonary adema(WIPO).
- Assess the risk factors of WIPO.
- Evaluate the role of lung ultrasound in detecting WIPO during spontenous breathing trial(SBT).
- Detect the threshold of B-line increase (Delta-B-lines) that provided the best diagnostic accuracy of WIPO.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Other: lung ultrasoundpatient who will develop weaning induced pulmonary adema |
| group 2 | – | Other: lung ultrasoundpatient who will nor develop weaning induced pulmonary adema |
Who may qualify
- Ages
- Up to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study will include patients on mechanical ventilation who will be suitable for spontaneous breathing trial (SBT).
Key inclusion criteria (1 listed)
- The study will include patients on mechanical ventilation who will be suitable for spontaneous breathing trial (SBT).
Key exclusion criteria (1 listed)
- Patients with poor lung ultrasound window, history of cardiomyopathy, significant valvular disease (aortic or mitral insufficiency of grade ≥ 2, mild or severe aortic and mitral stenosis) will be excluded from the study.
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 |
|---|---|---|
| lung ultrasoundpatient with or without weaning induced pulmonary adema | Other | group 1, group 2 |
Primary outcome
the number of B-lines in lung ultrasound and its accuracy in diagnosis of weaning induced pulmonary oedema
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Detecting the Number of B-lines in Lung Ultrasound and Its Accuracy in Diagnosis of Weaning Induced Pulmonary Oedema, run by Assiut University.
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 1 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 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of B-lines in lung ultrasound and its accuracy in diagnosis of weaning induced pulmonary oedema (time frame: 1 year). 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 9 Jul 2020.