Lung Ultrasound ScoreNCT05289960
Lung Ultrasound Score and Weaning Outcome
A study testing lung ultrasound in people with Lung Ultrasound Score and Acute Respiratory Failure, run by Cairo University at 1 site in Egypt.
Trial summary
Objectives: Failure of extubation of patients on mechanical ventilation is one of the common problems in the ICU. Aim of work: To evaluate the validity of lung ultrasound score in prediction of weaning outcomes and post-extubation distress. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Ultrasound Score, Acute Respiratory Failure
- What is being tested?
- lung ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to 1 Mar 2022
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients age > 18 years
- 2. Patients intubated and mechanically ventilated for more than 48 hours in the intensive care unit and planned for extubation.
Who cannot join
- 1. Patients < or =18 years 2. Patients with left ventricular failure
- 3. Right ventricular failure
- 4. Pulmonary hypertension
- 5. Aortic valve disease
- 6. Hyperthyroidism
- 7. Tracheostomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lung Ultrasound Score for Prediction of Weaning Outcome
Objectives: Failure of extubation of patients on mechanical ventilation is one of the common problems in the ICU.
Aim of work: To evaluate the validity of lung ultrasound score in prediction of weaning outcomes and post-extubation distress.
Read the detailed description
Methods: A prospective observational study of 50 patients planned for extubation who passed a spontaneous breathing trial, lung ultrasound score and serum level of NT-PRO BNP were done to all patients at end of spontaneous breathing trial, and all patients were followed after extubation and monitored for oxygenation, re-intubation rate, ICU stay, and ICU mortality.
- Conditions
- Lung Ultrasound Score, Acute Respiratory 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
Lung ultrasound score was done at the end of SBT using curved array ultrasound probe 2-5 MHz, Siemens X300, Korea
| Study group | Role | What they receive |
|---|---|---|
| patients eligible for weaning by spontaneous breathing trial | Other | Not described Receives: Other: lung ultrasound |
| non invasive ventilation after weaning | Other | Not described Receives: Other: lung ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation success
number of participants that do not need for respiratory support neither NIV nor intubation for one week during ICU stay
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 posted22 Mar 2022
- Study start1 Dec 2020
- Primary completion28 Feb 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Ultrasound ScoreStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Farouk, Cairo University
- Investigators
- farouk faris, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289960
- Sponsor's protocol ID
- MS-490-2020
- Status last verified
- Mar 2022
- First submitted
- 2 Mar 2022
- Last updated
- 1 Apr 2022
- 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 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Ultrasound Score for Prediction of Weaning Outcome
- ClinicalTrials.gov ID
- NCT05289960
- Acronym / sponsor ID
- MS-490-2020
- Conditions
- Lung Ultrasound Score, Acute Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 22 Mar 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.
Objectives: Failure of extubation of patients on mechanical ventilation is one of the common problems in the ICU.
Aim of work: To evaluate the validity of lung ultrasound score in prediction of weaning outcomes and post-extubation distress.
Detailed description
Methods: A prospective observational study of 50 patients planned for extubation who passed a spontaneous breathing trial, lung ultrasound score and serum level of NT-PRO BNP were done to all patients at end of spontaneous breathing trial, and all patients were followed after extubation and monitored for oxygenation, re-intubation rate, ICU stay, and ICU mortality.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients eligible for weaning by spontaneous breathing trial | Other | Other: lung ultrasound |
| non invasive ventilation after weaning | Other | Other: lung ultrasound |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Patients age > 18 years
- 2. Patients intubated and mechanically ventilated for more than 48 hours in the intensive care unit and planned for extubation.
Key exclusion criteria (6 listed)
- 1. Patients < or =18 years 2. Patients with left ventricular failure
- 3. Right ventricular failure
- 4. Pulmonary hypertension
- 5. Aortic valve disease
- 6. Hyperthyroidism
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 ultrasoundLung ultrasound score was done at the end of SBT using curved array ultrasound probe 2-5 MHz, Siemens X300, Korea | Other | non invasive ventilation after weaning, patients eligible for weaning by spontaneous breathing trial |
Primary outcome
Extubation success
Time frame: 48 hours
number of participants that do not need for respiratory support neither NIV nor intubation for one week during ICU stay
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 1 Apr 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.
farouk faris, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lung ultrasound in people with Lung Ultrasound Score and Acute Respiratory Failure, run by Cairo 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 2 inclusion and 6 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 1 Apr 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?
Extubation success (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 1 Apr 2022.