Ventilated Patient in Intensive CareNCT07630662
Effectiveness of Diaphragmatic Function and Parasternal Intercostal Muscles Functions as Predictors for Successful Weaning From Mechanical Ventilation
An observational study of Ventilated Patient in Intensive Care, run by Ain Shams University at 1 site in Egypt.
Trial summary
Critically ill patients frequently develop respiratory muscle dysfunction that may contribute to difficult and prolonged weaning from mechanical ventilation. that is besides complications such as barotrauma, ventilator-acquired pneumonia, accumulation of secretions, and lung atelectasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilated Patient in Intensive Care
- How many people
- 77 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 1 Aug 2026
- How long will I take part?
- 2 Days
- 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: intubated ventilated patients in ICU for more than 48 h
Who may be able to join
- 1. Adult patients more than 18 years old. 2. Patient on mechanical ventilation more than 48 hours.
Who cannot join
- 1. Declining to give a written informed consent. 2. Diaphragmatic paralysis or injury
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ain shams university hospitals
Cairo
Mohamed I Ezz Eldein, +2-1148394581, mohamedislam@med.asu.edu.eg
About this study
Official title: Ultrasound Evaluation of Diaphragmatic Functions and Parasternal Intercostal Muscle Thickening Fraction as Predictors of Successful Weaning From Mechanical Ventilation.
Critically ill patients frequently develop respiratory muscle dysfunction that may contribute to difficult and prolonged weaning from mechanical ventilation. that is besides complications such as barotrauma, ventilator-acquired pneumonia, accumulation of secretions, and lung atelectasis.
The ultrasound estimation of parasternal intercostal muscle and diaphragmatic functions is a method to evaluate if there is a good chance of weaning outcomes.
Read the detailed description
Mechanical ventilation is a commonly used therapeutic strategy in the Intensive care unit (ICU) by providing adequate oxygenation and ventilation until improvement of the patient's condition.
Serious consequences usually follow prolonged mechanical ventilation (MV) such as barotraumas and ventilator-associated pneumonia.
On the other hand, early discontinuation of ventilation is associated with adverse cardiovascular events. Therefore, time of extubation should be anticipated properly.
Respiratory muscle dysfunction is one of the leading reasons for difficult to wean population.
There is growing evidence about the use of diaphragmatic ultrasound in evaluating both need for and weaning from mechanical ventilation. However, diaphragmatic ultrasound carry some drawbacks such as lack of echogenicity and difficult to examine left side.
Extra-diaphragmatic muscles (including parasternal intercostal muscles, scalene muscles, and sternocleidomastoid) act hand-in-hand with diaphragm to complete mechanical pump actions therefore in case of diaphragmatic dysfunction accessory respiratory muscles increase their work. This could be a possible compensatory mechanism.
Evidence support the use of parasternal intercostal muscles as a predictor of need and weaning from mechanical ventilation with perfect inter-observer reliability that could provide further details about respiratory capacity/load harmony.
We, therefore, decided to study ultrasound assessment of these muscles during weaning from MV in critically ill patients.
- Conditions
- Ventilated Patient in Intensive Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| diaphragmatic and parasternal muscles function assessment | Patients who fulfilling the initial parameters for possibility of weaning will undergo spontaneous breathing trial (SBT) for 30 minutes. All patients will be positioned in a semi sitting position at approximately 30 degree, and will be monitored closely during SBT period. Ultrasound assessment for the parasternal intercostal and diaphragmatic muscle functions will be done at the end of SBTs for all patients. Ultrasound assessment of diaphragm: Diaphragmatic excursion; The diaphragmatic movement will be measured using a 3.5-MHz ultrasound probe. With the probe fixed on the chest wall during respiration, the patient will be asked to take a maximum breath. The right hemi-diaphragm will be measured by positioning the probe between the mid-clavicular and mid-axillary lines below the right costal margin (subcostal approach) using the liver as acoustic window. The probe will be positioned medially, cephalic and dorsally. Till the hemi-diaphragm will be well visualized. The M-mood will be ap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound guided muscles function assessment
- Evaluation of the efficacy of diaphragmatic and parasternal intercostal muscle functions as a predictors of successful weaning from mechanical ventilation.
Measured: 30-60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start1 Jan 2026
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilated Patient in Intensive CareStudies 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
- 77 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed islam ezz el dein amer, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630662
- Sponsor's protocol ID
- FMASU MD194a/2024/2026
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 5 Jun 2026
- 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 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Evaluation of Diaphragmatic Functions and Parasternal Intercostal Muscle Thickening Fraction as Predictors of Successful Weaning From Mechanical Ventilation.
- ClinicalTrials.gov ID
- NCT07630662
- Acronym / sponsor ID
- FMASU MD194a/2024/2026
- Conditions
- Ventilated Patient in Intensive Care
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 5 Jun 2026 (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.
Critically ill patients frequently develop respiratory muscle dysfunction that may contribute to difficult and prolonged weaning from mechanical ventilation. that is besides complications such as barotrauma, ventilator-acquired pneumonia, accumulation of secretions, and lung atelectasis.
The ultrasound estimation of parasternal intercostal muscle and diaphragmatic functions is a method to evaluate if there is a good chance of weaning outcomes.
Detailed description
Mechanical ventilation is a commonly used therapeutic strategy in the Intensive care unit (ICU) by providing adequate oxygenation and ventilation until improvement of the patient's condition.
Serious consequences usually follow prolonged mechanical ventilation (MV) such as barotraumas and ventilator-associated pneumonia.
On the other hand, early discontinuation of ventilation is associated with adverse cardiovascular events. Therefore, time of extubation should be anticipated properly.
Respiratory muscle dysfunction is one of the leading reasons for difficult to wean population.
There is growing evidence about the use of diaphragmatic ultrasound in evaluating both need for and weaning from mechanical ventilation. However, diaphragmatic ultrasound carry some drawbacks such as lack of echogenicity and difficult to examine left side.
Extra-diaphragmatic muscles (including parasternal intercostal muscles, scalene muscles, and sternocleidomastoid) act hand-in-hand with diaphragm to complete mechanical pump actions therefore in case of diaphragmatic dysfunction accessory respiratory muscles increase their work. This could be a possible compensatory mechanism.
Evidence support the use of parasternal intercostal muscles as a predictor of need and weaning from mechanical ventilation with perfect inter-observer reliability that could provide further details about respiratory capacity/load harmony.
We, therefore, decided to study ultrasound assessment of these muscles during weaning from MV in critically ill patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diaphragmatic and parasternal muscles function assessment | – | –Patients who fulfilling the initial parameters for possibility of weaning will undergo spontaneous breathing trial (SBT) for 30 minutes. All patients will be positioned in a semi sitting position at approximately 30 degree, and will be monitored closely during SBT period. Ultrasound assessment for the parasternal intercostal and diaphragmatic muscle functions will be done at the end of SBTs for all patients. Ultrasound assessment of diaphragm: Diaphragmatic excursion; The diaphragmatic movement will be measured using a 3.5-MHz ultrasound probe. With the probe fixed on the chest wall during respiration, the patient will be asked to take a maximum breath. The right hemi-diaphragm will be measured by positioning the probe between the mid-clavicular and mid-axillary lines below the right costal margin (subcostal approach) using the liver as acoustic window. The probe will be positioned medially, cephalic and dorsally. Till the hemi-diaphragm will be well visualized. The M-mood will be ap |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- intubated ventilated patients in ICU for more than 48 h
Key inclusion criteria (1 listed)
- 1. Adult patients more than 18 years old. 2. Patient on mechanical ventilation more than 48 hours.
Key exclusion criteria (1 listed)
- 1. Declining to give a written informed consent. 2. Diaphragmatic paralysis or injury
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
Ultrasound guided muscles function assessment
Time frame: 30-60 minutes
- Evaluation of the efficacy of diaphragmatic and parasternal intercostal muscle functions as a predictors of 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 5 Jun 2026.
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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.
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 Ventilated Patient in Intensive Care, 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 1 inclusion and 1 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 5 Jun 2026. 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 I Ezz eldein (+2-1148394581, mohamedislam@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound guided muscles function assessment (time frame: 30-60 minutes). 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 5 Jun 2026.