LungNCT07057804
Lung and Diaphragm Ultrasound in Predicting Extubation and Weaning of Mechanically Ventilated Patients in Intensive Care Unit
An observational study of Lung and Diaphragm, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
This study aims to evaluate the role of lung ultrasound score (LUS), diaphragmatic excursion (DE), and diaphragmatic thickening fraction (DTF) as predictors of successful extubation in mechanically ventilated patients in the intensive care unit (ICU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung, Diaphragm, Ultrasound
- What is being tested?
- Lung Ultrasound and Diaphragm Ultrasound
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 1 Jun 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study trial was carried out on 90 patients required invasive mechanical ventilation for a minimum of 24 hours and weaning criteria.
Who may be able to join
- All patients who will meet the following weaning criteria undergo Spontaneous Breathing Trial, which include,
- Improvement of disease acute phase which necessitated mechanical ventilation.
- Stable neurological status.
- No hemodynamic instability (heart rate ≤ 120/min, systolic blood pressure higher than 90 mmHg and lower than 160 mmHg) in the absence of any vasoactive support therapy.
- PaO2>60 mm Hg or SaO2 ≥ 90% or more with FiO2 ≤ 0.4.
- Afebrile and there were no significant abnormalities in the electrolyte levels.
Who cannot join
- Hemodynamic unstable patients
- Patients with severe intracranial disease,
- Tracheostomy.
- Severe intensive care unit (ICU) acquired neuromyopathy, with primary unilateral/bilateral absence of diaphragmatic mobility,
- Patients who had previously failed spontaneous breathing trial (SBT).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Kafrelsheikh University
Kafr ash Shaykh, Kafr Elsheikh Governorate, 33516
About this study
Official title: Role of Lung and Diaphragm Ultrasound in Predicting Extubation and Weaning of Mechanically Ventilated Patients in Intensive Care Unit
This study aims to evaluate the role of lung ultrasound score (LUS), diaphragmatic excursion (DE), and diaphragmatic thickening fraction (DTF) as predictors of successful extubation in mechanically ventilated patients in the intensive care unit (ICU). It also compares these ultrasound-based parameters to traditional weaning criteria.
Read the detailed description
Mechanical ventilation is a necessary life support technology for critically ill patients. The weaning outcome affects the morbidity and mortality of patients when their primary disease improves.
Moreover, lung ultrasonography can be used as an effective measure in the evaluation of lung aeration which is useful during the weaning procedure as it reflect the aeration loss and consequently predict the respiratory distress in the postintubation period, a validated score termed the lung ultrasound score(LUS) can be used to evaluate the loss of lung aeration.
Numerous data measured through diaphragmatic ultrasonography have been recommended for the same purpose, which involve measurement of diaphragmatic muscle movement during inspiration or excursion during the respiratory cycle (DE), and diaphragmatic muscle thickening or diaphragmatic thickening fraction (DTF).
- Conditions
- Lung, Diaphragm, Ultrasound, Extubation, Weaning, Mechanically Ventilation
- Being tested
- Lung Ultrasound, Diaphragm Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung UltrasoundDiagnostic test
Ultrasound was performed at the bedside with the patient in a semi-recumbent position using a 3.5-5 MHz curvilinear probe. Lung ultrasound was conducted across 12 zones (anterior and posterior) to evaluate aeration and calculate the lung ultrasound score (LUS).
Diaphragm UltrasoundDiagnostic test
Ultrasound was performed at the bedside with the patient in a semi-recumbent position using a 3.5-5 MHz curvilinear probe. Diaphragmatic excursion and thickening fraction were measured on the right hemidiaphragm.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients who met the standard clinical weaning criteria underwent bedside lung and diaphragm ultrasound at the end of a successful spontaneous breathing trial (SBT). Receives: Diagnostic Test: Lung Ultrasound; Diagnostic Test: Diaphragm Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of extubation
Success rate of extubation was recorded
Measured: 48 hours post-extubation
Secondary outcomes (3)
Diaphragmatic Excursion (DE)
Assessment of diaphragmatic excursion as a predictor of weaning success, measured using ultrasound.
Measured: Within 1 hour prior to extubation
Diaphragmatic Thickening Fraction (DTF)
Assessment of diaphragmatic Thickening Fraction (DTF) as a predictor of weaning success, measured using ultrasound.
Measured: Within 1 hour prior to extubation
Lung Ultrasound Score (LUS)
Evaluation of lung Ultrasound Score (LUS) as a predictor of extubation outcome, measured before extubation using standard lung ultrasound protocols.
Measured: Within 1 hour prior to extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start1 Jun 2024
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LungStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mabrouk Elsayed Ibrahim, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057804
- Sponsor's protocol ID
- KFSIRB200-202
- Status last verified
- Jun 2025
- First submitted
- 30 Jun 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Lung and Diaphragm Ultrasound in Predicting Extubation and Weaning of Mechanically Ventilated Patients in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT07057804
- Acronym / sponsor ID
- KFSIRB200-202
- Conditions
- Lung, Diaphragm, Ultrasound, Extubation, Weaning, Mechanically Ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 10 Jul 2025 (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.
This study aims to evaluate the role of lung ultrasound score (LUS), diaphragmatic excursion (DE), and diaphragmatic thickening fraction (DTF) as predictors of successful extubation in mechanically ventilated patients in the intensive care unit (ICU). It also compares these ultrasound-based parameters to traditional weaning criteria.
Detailed description
Mechanical ventilation is a necessary life support technology for critically ill patients. The weaning outcome affects the morbidity and mortality of patients when their primary disease improves.
Moreover, lung ultrasonography can be used as an effective measure in the evaluation of lung aeration which is useful during the weaning procedure as it reflect the aeration loss and consequently predict the respiratory distress in the postintubation period, a validated score termed the lung ultrasound score(LUS) can be used to evaluate the loss of lung aeration.
Numerous data measured through diaphragmatic ultrasonography have been recommended for the same purpose, which involve measurement of diaphragmatic muscle movement during inspiration or excursion during the respiratory cycle (DE), and diaphragmatic muscle thickening or diaphragmatic thickening fraction (DTF).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: Lung Ultrasound, Diagnostic Test: Diaphragm UltrasoundPatients who met the standard clinical weaning criteria underwent bedside lung and diaphragm ultrasound at the end of a successful spontaneous breathing trial (SBT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study trial was carried out on 90 patients required invasive mechanical ventilation for a minimum of 24 hours and weaning criteria.
Key inclusion criteria (6 listed)
- All patients who will meet the following weaning criteria undergo Spontaneous Breathing Trial, which include,
Key exclusion criteria (5 listed)
- Hemodynamic unstable patients
- Patients with severe intracranial disease,
- Tracheostomy.
- Severe intensive care unit (ICU) acquired neuromyopathy, with primary unilateral/bilateral absence of diaphragmatic mobility,
- Patients who had previously failed spontaneous breathing trial (SBT).
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 UltrasoundUltrasound was performed at the bedside with the patient in a semi-recumbent position using a 3.5-5 MHz curvilinear probe. Lung ultrasound was conducted across 12 zones (anterior and posterior) to evaluate aeration and calculate the lung ultrasound score (LUS). | Diagnostic test | Study group |
| Diaphragm UltrasoundUltrasound was performed at the bedside with the patient in a semi-recumbent position using a 3.5-5 MHz curvilinear probe. Diaphragmatic excursion and thickening fraction were measured on the right hemidiaphragm. | Diagnostic test | Study group |
Primary outcome
Success rate of extubation
Time frame: 48 hours post-extubation
Success rate of extubation was recorded
3 secondary outcomes
Diaphragmatic Excursion (DE)
Time frame: Within 1 hour prior to extubation
Diaphragmatic Thickening Fraction (DTF)
Time frame: Within 1 hour prior to extubation
Lung Ultrasound Score (LUS)
Time frame: Within 1 hour prior to extubation
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 10 Jul 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 Lung and Diaphragm, run by Kafrelsheikh 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 6 inclusion and 5 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 10 Jul 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?
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?
Success rate of extubation (time frame: 48 hours post-extubation). 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 10 Jul 2025.