Weaning From Mechanical VentilationNCT06465082
Diaphragmatic Thickening Fraction as a Predictor of Successful Weaning
An observational study of Weaning From Mechanical Ventilation, run by Mansoura University Hospital at 1 site in Egypt.
Trial summary
The aim of this study is to assess the validity of the diaphragmatic thickening Fraction measured by ultrasound as a predictor for successful weaning from mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning From Mechanical Ventilation
- How many people
- 55 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Sep 2024to 15 Dec 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult patients >18 years old, who are in need for mechanical ventilation as: Life threatening hypoxia, Respiratory rate > 30 breath/min, Disturbed conscious level.
Who may be able to join
- Adult patients >18 years old, who are in need for mechanical ventilation as: Life threatening hypoxia, Respiratory rate > 30 breath/min, Disturbed conscious level.
Who cannot join
- Age <18 years.
- Pregnancy
- Surgical incisions likely to interfere with ultrasound examination.
- Hepato-splenomegaly, Ascites
- Neuromuscular disease as Myasthenia gravis, kypho-scoliosis
- Diaphragmatic Paralysis (paralyzed diaphragm exhibiting abnormal paradoxical movement, i.e., moving in a cranial direction during inspiration
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taha Taha Abd El Gawad contact
Egypt1 site, 1 recruiting
- Recruiting
Mohamed AbdElmoniem
Al Mansurah, 35516
Mohamed AbdElmoniem, 01014008473, dr.m1993@mans.edu.eg
dr.m1993@mans.edu.eg
About this study
Official title: Role of Diaphragmatic Thickening Fraction as a Predictor of Successful Weaning From Mechanical Ventilation
The aim of this study is to assess the validity of the diaphragmatic thickening Fraction measured by ultrasound as a predictor for successful weaning from mechanical ventilation.
Read the detailed description
Timing is critical for proper weaning for patients undergoing mechanical ventilation; if this is performed prematurely complications can include increased cardiovascular and respiratory stress, CO2 retention and hypoxemia. However, unnecessary delay in weaning can also cause a number of side-effects.Weaning outcomes have been assessed by several indices. Variables such as minute ventilation, Pao2/Fio2, rapid shallow breathing index and static compliance have all been used, with variable predictive values. Previous studies have proved that diaphragmatic dysfunction is one of the main etiologies of difficult weaning, because the diaphragm progressively weakens with mechanical ventilation.Methods used to assess diaphragm function, such as fluoroscopy, phrenic nerve stimulation, measurement of trans-diaphragmatic pressure and dynamic magnetic resonance imaging of the diaphragm, all have limitations. These include ionizing radiation exposure, low availability, invasiveness and necessity for patient transportation. Conversely, the use of ultrasound is safe, non-invasive, avoids radiation side-effects, and is available at the bedside.The aim of this study is to assess the validity of the diaphragmatic thickening Fraction measured by ultrasound as a predictor for successful weaning from mechanical ventilation.
- Conditions
- Weaning From Mechanical Ventilation
- Keywords
- mechanical ventilation., diaphragmatic thickening Fraction
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragmatic thickening Fraction as predictor for weaning from mechanical ventilation.
assess the validity of the diaphragmatic thickening Fraction measured by ultrasound as a predictor for successful weaning from mechanical ventilation.
Measured: Baseline and after 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start5 Sep 2024
- Primary completion15 Jul 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weaning From Mechanical VentilationStudies of the same condition, open and under way.
- 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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 55 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Mansoura University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abd Elmoniem Mohamed, Mansoura University Hospital
- Investigators
- Mohamed AbdElmoniem, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06465082
- Sponsor's protocol ID
- R.24.05.2632
- Status last verified
- May 2025
- First submitted
- 13 Jun 2024
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Diaphragmatic Thickening Fraction as a Predictor of Successful Weaning From Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT06465082
- Acronym / sponsor ID
- R.24.05.2632
- Conditions
- Weaning From Mechanical Ventilation
- Keywords
- mechanical ventilation., diaphragmatic thickening Fraction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Mansoura University HospitalUniversity, hospital or other
- Study start
- 5 Sep 2024 (actual)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 18 Jun 2024 (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 assess the validity of the diaphragmatic thickening Fraction measured by ultrasound as a predictor for successful weaning from mechanical ventilation.
Detailed description
Timing is critical for proper weaning for patients undergoing mechanical ventilation; if this is performed prematurely complications can include increased cardiovascular and respiratory stress, CO2 retention and hypoxemia. However, unnecessary delay in weaning can also cause a number of side-effects.Weaning outcomes have been assessed by several indices. Variables such as minute ventilation, Pao2/Fio2, rapid shallow breathing index and static compliance have all been used, with variable predictive values. Previous studies have proved that diaphragmatic dysfunction is one of the main etiologies of difficult weaning, because the diaphragm progressively weakens with mechanical ventilation.Methods used to assess diaphragm function, such as fluoroscopy, phrenic nerve stimulation, measurement of trans-diaphragmatic pressure and dynamic magnetic resonance imaging of the diaphragm, all have limitations. These include ionizing radiation exposure, low availability, invasiveness and necessity for patient transportation. Conversely, the use of ultrasound is safe, non-invasive, avoids radiation side-effects, and is available at the bedside.The aim of this study is to assess the validity of the diaphragmatic thickening Fraction measured by ultrasound as a predictor for successful weaning from mechanical ventilation.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients >18 years old, who are in need for mechanical ventilation as: Life threatening hypoxia, Respiratory rate > 30 breath/min, Disturbed conscious level.
Key inclusion criteria (1 listed)
- Adult patients >18 years old, who are in need for mechanical ventilation as: Life threatening hypoxia, Respiratory rate > 30 breath/min, Disturbed conscious level.
Key exclusion criteria (6 listed)
- Age <18 years.
- Pregnancy
- Surgical incisions likely to interfere with ultrasound examination.
- Hepato-splenomegaly, Ascites
- Neuromuscular disease as Myasthenia gravis, kypho-scoliosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diaphragmatic thickening Fraction as predictor for weaning from mechanical ventilation.
Time frame: Baseline and after 6 month
assess the validity of the diaphragmatic thickening Fraction measured by ultrasound as a predictor for successful weaning from mechanical ventilation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
Related trials for Weaning From Mechanical Ventilation
Recruiting
A Randomized Clinical Trial for Predictors of Successful Extubation of Pediatric Patients With or Without High Velocity Nasal Insufflation
High Velocity Nasal Insufflation, Simple Oxygen
Not yet recruitingObservational study
Detecting Early Weaning-induced Pulmonary Oedema Using Lung Impedance Negative Trend During Spontaneous Breathing Trials
Weaning-induced Pulmonary Edema, Mechanical Ventilation Weaning
Not yet recruitingObservational study
Intra-Abdominal Pressure, Respiratory Mechanics, and Ventilator Liberation After Emergency Major Laparotomy
Intra-Abdominal Hypertension, Respiratory Mechanics
Not yet recruiting
High-Flow Tracheal Oxygen During Spontaneous Breathing Trial
Mechanical Ventilation Weaning, Spontaneous Breathing Trial
Recruiting
Physiological Effect High-flow Tracheal Oxygen on Viscosity of Airway Mucus and Respiratory Effort in Patients Weaning From Invasive Mechanical Ventilation
Weaning From Mechanical Ventilation, Tracheostomy Weaning
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.
Taha Taha Abd El Gawad contact
Mohamed AbdElmoniem principal investigator
Mansoura University
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 From Mechanical Ventilation, run by Mansoura University Hospital 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 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: looking for participants now, as of the sponsor's last update on 29 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed AbdElmoniem (01014008473, dr.m1993@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragmatic thickening Fraction as predictor for weaning from mechanical ventilation. (time frame: Baseline and after 6 month). 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 29 May 2025.