Weaning FailureNCT05617989
Role of Non-invasive Mechanical Ventilation and Diuretics in Improving Weaning Outcome of Patients With High Lung Ultrasound Score
An observational study of Weaning Failure, run by Ain Shams University at 1 site in Egypt.
Trial summary
patients who succeeded in SBT with high lung scores by ultrasound, non-invasive ventilation, and diuretic may have a role. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Weaning Failure
- What is being tested?
- lung ultrasound
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Apr 2020to 10 Apr 2022
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: mechanical ventilated more than 48 h with high lung score
Who may be able to join
- age ≥ 21 years of age
- mechanical ventilation for more than 48 hrs
- patients successfully passed according to the traditional weaning criteria
- lung ultrasound score ≥ 17.
Who cannot join
- Significant obstructive lung diseases
- Obstructive sleep apnea
- Interstitial lung disease
- Neuromuscular disorders
Trial locations and contacts
1 site in 1 country.
About this study
patients who succeeded in SBT with high lung scores by ultrasound, non-invasive ventilation, and diuretic may have a role.
- Conditions
- Weaning Failure
- 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
non-invasive ventilation and diuretic
What is being measured
The primary outcome is the main question the study is designed to answer.
weaning failure ( number of patients)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start30 Apr 2020
- Primary completion4 Dec 2021
- Study completion10 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weaning FailureStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Ammar, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05617989
- Sponsor's protocol ID
- MD 243/2020
- Status last verified
- Nov 2022
- First submitted
- 3 Nov 2022
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Non-invasive Mechanical Ventilation and Diuretics in Improving Weaning Outcome of Patients With High Lung Ultrasound Score
- ClinicalTrials.gov ID
- NCT05617989
- Acronym / sponsor ID
- MD 243/2020
- Conditions
- Weaning Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 Apr 2020 (actual)
- Primary completion
- 4 Dec 2021 (actual)
- Study completion
- 10 Apr 2022 (actual)
- First posted
- 16 Nov 2022 (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.
patients who succeeded in SBT with high lung scores by ultrasound, non-invasive ventilation, and diuretic may have a role.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- mechanical ventilated more than 48 h with high lung score
Key inclusion criteria (4 listed)
- age ≥ 21 years of age
- mechanical ventilation for more than 48 hrs
- patients successfully passed according to the traditional weaning criteria
- lung ultrasound score ≥ 17.
Key exclusion criteria (4 listed)
- Significant obstructive lung diseases
- Obstructive sleep apnea
- Interstitial lung disease
- Neuromuscular disorders
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 ultrasoundnon-invasive ventilation and diuretic | Other | – |
Primary outcome
weaning failure ( number of patients)
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Weaning Failure, run by Ain Shams 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 4 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: finished, as of the sponsor's last update on 16 Nov 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
weaning failure ( number of patients) (time frame: 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 16 Nov 2022.