UltrasonographyNCT07082361
The Use of Diaphragmatic Ultrasonography in Mechanical Ventilation Weaning Decision in COPD Patient
A study testing conventional clinical criteria of weaning from mechanical ventilation and conventional clinical criteria and ultrasonic criteria for weaning in people with Ultrasonography and Mechanical Ventilation Weaning, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the use of diaphragmatic ultrasonography in taking mechanical ventilation weaning decision and predicting outcome in Chronic obstructive pulmonary disease patient. Primary outcome: Number of patients with failed weaning trial and need reintubation. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Ultrasonography, Mechanical Ventilation Weaning, Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- conventional clinical criteria of weaning from mechanical ventilation and conventional clinical criteria and ultrasonic criteria for weaning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Oct 2025to 30 Dec 2025
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient more than 21 years old of both sexes, coming to our intensive care unit with acute exacerbation of Chronic obstructive pulmonary disease \& need mechanical ventilation at least 48 hr.
Who cannot join
- Patient refusal.
- Morbid obesity with body mass index > 35 kg/m2.
- Patients with a history of recent thoracic surgery.
- Neuromuscular disorders affecting the diaphragm e.g.(myopathy).
- Congenital diaphragmatic disorders (Hiatal hernia).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Tanta University
Tanta, Gharbia Governorate
Shimaa Badr, Resident, 01099531489, aliaamohamedali@gmail.com
About this study
Official title: The Use of Diaphragmatic Ultrasonography: Does It Change Mechanical Ventilation Weaning Decision and Predict Outcome in COPD Patient?
The aim of this study is to evaluate the use of diaphragmatic ultrasonography in taking mechanical ventilation weaning decision and predicting outcome in Chronic obstructive pulmonary disease patient.
Primary outcome:
- Number of patients with failed weaning trial and need reintubation.
Secondary outcomes:
- Time till extubation trial.
- Ventilation free days after extubation less or more than 48h .
- Number of Intensive care unit discharges.
- Sensitivity and specificity of diaphragmatic assessment as a predictor of weaning.
Read the detailed description
Chronic obstructive pulmonary disease is the fourth killer among all diseases worldwide. It can be prevented and treated, so it is an important public health challenge. Inspiratory muscle weakness has a great clinical association with Chronic obstructive pulmonary disease patients. The prolonged mechanical ventilation and weaning failure may be related to diaphragmatic muscle dysfunction. The traditional weaning parameters (e.g., spontaneous tidal volume ), Maximum inspiratory pressure , and rapid shallow breathing index are considered useful parameters for weaning. Although, they have unsatisfactory prediction rates.
Exacerbation of Chronic obstructive pulmonary disease is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management .
In most patients, mechanical ventilation can be discontinued as soon as the underlying reason for acute respiratory failure has been resolved. However, Patients spend receiving mechanical ventilation is devoted to weaning and increase up to, 59% in Chronic obstructive pulmonary disease patients .
There are innumerable factors responsible for the failure of weaning from mechanical ventilation. Factors that should be considered in all patients include misadjusted ventilator settings, infections, airway patency and respiratory muscle performance. Malnutrition, which is common in ventilator dependent patients, has detrimental effects on the respiratory system. Heart failure or coronary ischemia can be induced by the reduction of ventilatory support which causes weaning failure. A number of electrolyte imbalances and psychological problems can be an impediment to successful weaning.
Diaphragmatic ultrasound is non-invasive, radiation-free, widely available, provides immediate and accurate results, and can be repeated at the bedside . Diaphragm sonography values provide useful information for assessing and monitoring mechanically ventilated patients .
The aim of this study is to evaluate the use of diaphragmatic ultrasonography in taking mechanical ventilation weaning decision and predicting outcome in Chronic obstructive pulmonary disease patient.
A randomized controlled study will be carried out on patients admitted to Anesthesia \& Surgical intensive care unit Department in Tanta University Hospitals over a period of 1 year
- Conditions
- Ultrasonography, Mechanical Ventilation Weaning, Chronic Obstructive Pulmonary Disease (COPD)
- Being tested
- conventional clinical criteria of weaning from mechanical ventilation, conventional clinical criteria and ultrasonic criteria for weaning
- Keywords
- Ultrasonography, Diaphragmatic, Mechanical Ventilation, Weaning
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional clinical criteria of weaning from mechanical ventilationDiagnostic test
Patients will be weaned after fulfilling the conventional clinical criteria of weaning from mechanical ventilation by using spontaneous breathing trials
conventional clinical criteria and ultrasonic criteria for weaningDiagnostic test
Patients will be weaned using the conventional clinical criteria and ultrasonic criteria for weaning.
| Study group | Role | What they receive |
|---|---|---|
| conventional clinical criteria of weaning from mechanical ventilation by using spontaneous breathing | Experimental | Patients will be weaned after fulfilling the conventional clinical criteria of weaning from mechanical ventilation by using spontaneous breathing trials Receives: Diagnostic Test: conventional clinical criteria and ultrasonic criteria for weaning |
| conventional clinical criteria and ultrasonic criteria for weaning | Experimental | Patients will be weaned using the conventional clinical criteria and ultrasonic criteria for weaning. Receives: Diagnostic Test: conventional clinical criteria of weaning from mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with failed weaning trial
Measured: 28 day
Secondary outcomes (2)
Time till extubation trial.
Measured: 28 days
Number of Intensive care unit discharges
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start30 Oct 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasonographyStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Adel Mohamed Helmy Badr, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082361
- Sponsor's protocol ID
- 36264MS719/10/24
- Status last verified
- Oct 2024
- First submitted
- 16 Jul 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Diaphragmatic Ultrasonography: Does It Change Mechanical Ventilation Weaning Decision and Predict Outcome in COPD Patient?
- ClinicalTrials.gov ID
- NCT07082361
- Acronym / sponsor ID
- 36264MS719/10/24
- Conditions
- Ultrasonography, Mechanical Ventilation Weaning, Chronic Obstructive Pulmonary Disease (COPD)
- Keywords
- Ultrasonography, Diaphragmatic, Mechanical Ventilation, Weaning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Oct 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 24 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.
The aim of this study is to evaluate the use of diaphragmatic ultrasonography in taking mechanical ventilation weaning decision and predicting outcome in Chronic obstructive pulmonary disease patient.
Primary outcome:
- Number of patients with failed weaning trial and need reintubation.
Secondary outcomes:
- Time till extubation trial.
- Ventilation free days after extubation less or more than 48h .
- Number of Intensive care unit discharges.
- Sensitivity and specificity of diaphragmatic assessment as a predictor of weaning.
Detailed description
Chronic obstructive pulmonary disease is the fourth killer among all diseases worldwide. It can be prevented and treated, so it is an important public health challenge. Inspiratory muscle weakness has a great clinical association with Chronic obstructive pulmonary disease patients. The prolonged mechanical ventilation and weaning failure may be related to diaphragmatic muscle dysfunction. The traditional weaning parameters (e.g., spontaneous tidal volume ), Maximum inspiratory pressure , and rapid shallow breathing index are considered useful parameters for weaning. Although, they have unsatisfactory prediction rates.
Exacerbation of Chronic obstructive pulmonary disease is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management .
In most patients, mechanical ventilation can be discontinued as soon as the underlying reason for acute respiratory failure has been resolved. However, Patients spend receiving mechanical ventilation is devoted to weaning and increase up to, 59% in Chronic obstructive pulmonary disease patients .
There are innumerable factors responsible for the failure of weaning from mechanical ventilation. Factors that should be considered in all patients include misadjusted ventilator settings, infections, airway patency and respiratory muscle performance. Malnutrition, which is common in ventilator dependent patients, has detrimental effects on the respiratory system. Heart failure or coronary ischemia can be induced by the reduction of ventilatory support which causes weaning failure. A number of electrolyte imbalances and psychological problems can be an impediment to successful weaning.
Diaphragmatic ultrasound is non-invasive, radiation-free, widely available, provides immediate and accurate results, and can be repeated at the bedside . Diaphragm sonography values provide useful information for assessing and monitoring mechanically ventilated patients .
The aim of this study is to evaluate the use of diaphragmatic ultrasonography in taking mechanical ventilation weaning decision and predicting outcome in Chronic obstructive pulmonary disease patient.
A randomized controlled study will be carried out on patients admitted to Anesthesia \& Surgical intensive care unit Department in Tanta University Hospitals over a period of 1 year
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional clinical criteria of weaning from mechanical ventilation by using spontaneous breathing | Experimental | Diagnostic Test: conventional clinical criteria and ultrasonic criteria for weaningPatients will be weaned after fulfilling the conventional clinical criteria of weaning from mechanical ventilation by using spontaneous breathing trials |
| conventional clinical criteria and ultrasonic criteria for weaning | Experimental | Diagnostic Test: conventional clinical criteria of weaning from mechanical ventilationPatients will be weaned using the conventional clinical criteria and ultrasonic criteria for weaning. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patient more than 21 years old of both sexes, coming to our intensive care unit with acute exacerbation of Chronic obstructive pulmonary disease \& need mechanical ventilation at least 48 hr.
Key exclusion criteria (5 listed)
- Patient refusal.
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 |
|---|---|---|
| conventional clinical criteria of weaning from mechanical ventilationPatients will be weaned after fulfilling the conventional clinical criteria of weaning from mechanical ventilation by using spontaneous breathing trials | Diagnostic test | conventional clinical criteria and ultrasonic criteria for weaning |
| conventional clinical criteria and ultrasonic criteria for weaningPatients will be weaned using the conventional clinical criteria and ultrasonic criteria for weaning. | Diagnostic test | conventional clinical criteria of weaning from mechanical ventilation by using spontaneous breathing |
Primary outcome
Number of patients with failed weaning trial
Time frame: 28 day
2 secondary outcomes
Time till extubation trial.
Time frame: 28 days
Number of Intensive care unit discharges
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional clinical criteria of weaning from mechanical ventilation and conventional clinical criteria and ultrasonic criteria for weaning in people with Ultrasonography and Mechanical Ventilation Weaning, run by Tanta 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 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: status not confirmed, as of the sponsor's last update on 24 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shimaa Badr, Resident (+20 10 93734644, ahmed.mostafa.hassan2023@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with failed weaning trial (time frame: 28 day). 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 24 Jul 2025.