Weaning Failure of Mechanical VentilationNCT07044063
Use of Diaphragm Ultrasound and Evaluation of Respiratory Parameters in Determining Weaning Success in Geriatric Patients
An observational study of Weaning Failure of Mechanical Ventilation and Diaphragm Ultrasonography, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effectiveness of ultrasound-based diaphragmatic measurements in predicting weaning success in patients aged 65 and older who are receiving mechanical ventilation. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Weaning Failure of Mechanical Ventilation, Diaphragm Ultrasonography, Geriatric
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 1 May 2024
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients admitted to the intensive care unit of Kartal Dr. Lutfi Kirdar Training and Research Hospital who are 65 years or older and underwent mechanical ventilation
Who may be able to join
- 65 years and older
- Admitted to ICU
- Intubated and mechanically ventilated for at least 24 hours
- Clinically decided to wean from mechanical ventilation
Who cannot join
- Those who have mechanically ventilated for more than 14 days
- Those who have been tracheostomized
- Those with preexisting diaphragmatic paralysis or neuromuscular disease
- Those who had cardiothoracic surgery
- Those with muscular or musculoskeletal diseases
- Those with Glasgow Coma Scale lower than 10T without sedation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Kartal Dr. Lutfi Kirdar City Hospital
Istanbul, 34865
About this study
This study aims to evaluate the effectiveness of ultrasound-based diaphragmatic measurements in predicting weaning success in patients aged 65 and older who are receiving mechanical ventilation. Additionally, it seeks to contribute to the clinical decision-making process by examining the relationship between these measurements and conventional weaning parameters.
Read the detailed description
Weaning refers to the gradual reduction of mechanical ventilatory support. Approximately 40% of the time patients spend on mechanical ventilation is dedicated to the weaning process. Patients who fail the spontaneous breathing trial (SBT) or require reintubation within 48 hours after extubation are considered to have experienced weaning failure. Around 20-30% of patients receiving invasive mechanical ventilation are classified as difficult to wean.
In the geriatric population, the weaning process becomes even more challenging due to age-related changes such as decreased lung elasticity, reduced muscle mass, and diminished lung volumes. Although various scales have been developed to predict weaning success, their correlation with actual clinical outcomes remains uncertain.
The diaphragm is the primary muscle involved in active inspiration. Dysfunction of the diaphragm can lead to impaired cough reflex and respiratory failure. In recent years, ultrasonography (US) has been used to assess diaphragmatic thickness and movement through the right hemithorax during inspiration and expiration. From these measurements, parameters such as Diaphragm Thickness during inspiration and expiration (DTi and DTe), Diaphragm Thickening Fraction (DTF), and Diaphragm Excursion (DE) can be calculated. Several studies have investigated the association between these parameters and weaning success.
In this planned study, the investigators aim to evaluate the predictive value of ultrasound-derived diaphragmatic parameters (DTi, DTe, DTF, and DE) for weaning success in geriatric patients who are intubated and monitored in intensive care units. Additionally, investigators intend to assess the correlation between these parameters and other respiratory indicators.
The primary objective of this study is to examine the relationship between diaphragmatic parameters measured via ultrasonography within 24 hours prior to weaning and weaning outcomes in intubated ICU patients aged 65 years and older. The secondary objective is to compare the correlation of these parameters with other conventional respiratory parameters.
- Keywords
- diaphragm, ultrasound, geriatric, weaning, mechanical ventilation
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 |
|---|---|---|
| Weaning Success Group | Patients who are weaned from mechanical ventilation within 24 hours of diaphragmatic ultrasound measurements and didn't need mechanical ventilation again for at least 48 hours was placed in this group. | |
| Weaning Failure Group | Patients who are weaned from mechanical ventilation within 24 hours of diaphragmatic ultrasound measurements but needed mechanical ventilation support again within 48 hours after weaning was placed in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragm Thickness Measurement
Diaphragm thicknesses are measured with linear ultrasound probe at 8-10th intercostal space on anterior or middle axillary line using B-mode during inspiration and expiration.
Measured: Within 24 hours prior to weaning from mechanical ventilation.
Diaphragmatic Excursion Measurement
Diaphragmatic excursion is measured with convex probe at midclavicular line just below costal arch using M-mode during respiratory cycle.
Measured: Within 24 hours prior to weaning from mechanical ventilation.
Diaphragm Thickening Fraction
Diaphragmatic thickening fraction is calculated by taking the difference between diaphragm thickness at end-inspiration and diaphragm thickness at end-expiration, dividing it by the thickness at end-expiration, and multiplying by 100 to get a percentage.
Measured: Within 24 hours prior to weaning from mechanical ventilation.
Secondary outcomes (9)
Arterial Blood Gas
pH, Partial Pressure of Carbon Dioxide (mmHg) , Partial Pressure of Oxygen (mmHg), Oxygen Saturation(SaO2) values from arterial blood gas will be collected.
Measured: Within 24 hours prior to weaning from mechanical ventilation.
Oxygen Saturation
Peripheral Oxygen Saturation Percentage
Measured: Within 24 hours prior to weaning from mechanical ventilation
Respiratory Rate (Breaths per Minute)
Respiratory rate per minute will be collected.
Measured: Within 24 hours prior to weaning from mechanical ventilation
Rapid Shallow Breathing Index (Breath/Minute/L)
RSBI will be calculated by dividing respiratory rate per minute to tidal volume in liters.
Measured: Within 24 hours prior to weaning from mechanical ventilation
Mechanical Ventilation Duration (Hours)
Mechanical ventilation duration prior to the weaning trial of the patients was recorded in hours.
Measured: Within 24 hours prior to weaning from mechanical ventilation
PaO2/FiO2 (mmHg)
PaO2 from arterial blood gas analysis was divided by fractional inspired oxygen to calculate this value.
Measured: Within 24 hours prior to weaning from mechanical ventilation.
Tidal Volume and Minute Ventilation (L)
These values were collected from mechanical ventilator.
Measured: Within 24 hours prior to weaning from mechanical ventilation.
P0.1 (cmH2O)
P0. 1 is the negative airway pressure generated by the patient during the first 0.1 s against an occluded airway. P0. 1 can be obtained non-invasively in most new generation mechanical ventilators through a simple maneuver.
Measured: Within 24 hours prior to weaning from mechanical ventilation.
Dynamic Compliance (mL/cmH2O)
Dynamic compliance is measured by dividing the tidal volume, the average volume of air in one breath cycle, by the difference between the pressure of the lungs at full inspiration and full expiration. These values were collected from mechanical ventilator.
Measured: Within 24 hours prior to weaning from mechanical ventilation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start1 Dec 2023
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weaning Failure of 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ismail Yavuz Keles, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044063
- Sponsor's protocol ID
- DLKTRH-ANS-IYK-01
- Status last verified
- Oct 2026
- First submitted
- 9 Apr 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Diaphragm Ultrasound and Evaluation of Respiratory Parameters in Determining Weaning Success in Geriatric Patients
- ClinicalTrials.gov ID
- NCT07044063
- Acronym / sponsor ID
- DLKTRH-ANS-IYK-01
- Keywords
- diaphragm, ultrasound, geriatric, weaning, mechanical ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 29 Jun 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 effectiveness of ultrasound-based diaphragmatic measurements in predicting weaning success in patients aged 65 and older who are receiving mechanical ventilation. Additionally, it seeks to contribute to the clinical decision-making process by examining the relationship between these measurements and conventional weaning parameters.
Detailed description
Weaning refers to the gradual reduction of mechanical ventilatory support. Approximately 40% of the time patients spend on mechanical ventilation is dedicated to the weaning process. Patients who fail the spontaneous breathing trial (SBT) or require reintubation within 48 hours after extubation are considered to have experienced weaning failure. Around 20-30% of patients receiving invasive mechanical ventilation are classified as difficult to wean.
In the geriatric population, the weaning process becomes even more challenging due to age-related changes such as decreased lung elasticity, reduced muscle mass, and diminished lung volumes. Although various scales have been developed to predict weaning success, their correlation with actual clinical outcomes remains uncertain.
The diaphragm is the primary muscle involved in active inspiration. Dysfunction of the diaphragm can lead to impaired cough reflex and respiratory failure. In recent years, ultrasonography (US) has been used to assess diaphragmatic thickness and movement through the right hemithorax during inspiration and expiration. From these measurements, parameters such as Diaphragm Thickness during inspiration and expiration (DTi and DTe), Diaphragm Thickening Fraction (DTF), and Diaphragm Excursion (DE) can be calculated. Several studies have investigated the association between these parameters and weaning success.
In this planned study, the investigators aim to evaluate the predictive value of ultrasound-derived diaphragmatic parameters (DTi, DTe, DTF, and DE) for weaning success in geriatric patients who are intubated and monitored in intensive care units. Additionally, investigators intend to assess the correlation between these parameters and other respiratory indicators.
The primary objective of this study is to examine the relationship between diaphragmatic parameters measured via ultrasonography within 24 hours prior to weaning and weaning outcomes in intubated ICU patients aged 65 years and older. The secondary objective is to compare the correlation of these parameters with other conventional respiratory parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weaning Success Group | – | –Patients who are weaned from mechanical ventilation within 24 hours of diaphragmatic ultrasound measurements and didn't need mechanical ventilation again for at least 48 hours was placed in this group. |
| Weaning Failure Group | – | –Patients who are weaned from mechanical ventilation within 24 hours of diaphragmatic ultrasound measurements but needed mechanical ventilation support again within 48 hours after weaning was placed in this group. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients admitted to the intensive care unit of Kartal Dr. Lutfi Kirdar Training and Research Hospital who are 65 years or older and underwent mechanical ventilation
Key inclusion criteria (4 listed)
- 65 years and older
- Admitted to ICU
- Intubated and mechanically ventilated for at least 24 hours
- Clinically decided to wean from mechanical ventilation
Key exclusion criteria (6 listed)
- Those who have mechanically ventilated for more than 14 days
- Those who have been tracheostomized
- Those with preexisting diaphragmatic paralysis or neuromuscular disease
- Those who had cardiothoracic surgery
- Those with muscular or musculoskeletal diseases
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
Diaphragm Thickness Measurement
Time frame: Within 24 hours prior to weaning from mechanical ventilation.
Diaphragm thicknesses are measured with linear ultrasound probe at 8-10th intercostal space on anterior or middle axillary line using B-mode during inspiration and expiration.
Diaphragmatic Excursion Measurement
Time frame: Within 24 hours prior to weaning from mechanical ventilation.
Diaphragmatic excursion is measured with convex probe at midclavicular line just below costal arch using M-mode during respiratory cycle.
Diaphragm Thickening Fraction
Time frame: Within 24 hours prior to weaning from mechanical ventilation.
Diaphragmatic thickening fraction is calculated by taking the difference between diaphragm thickness at end-inspiration and diaphragm thickness at end-expiration, dividing it by the thickness at end-expiration, and multiplying by 100 to get a percentage.
9 secondary outcomes
Arterial Blood Gas
Time frame: Within 24 hours prior to weaning from mechanical ventilation.
Oxygen Saturation
Time frame: Within 24 hours prior to weaning from mechanical ventilation
Respiratory Rate (Breaths per Minute)
Time frame: Within 24 hours prior to weaning from mechanical ventilation
Rapid Shallow Breathing Index (Breath/Minute/L)
Time frame: Within 24 hours prior to weaning from mechanical ventilation
Mechanical Ventilation Duration (Hours)
Time frame: Within 24 hours prior to weaning from mechanical ventilation
PaO2/FiO2 (mmHg)
Time frame: Within 24 hours prior to weaning from mechanical ventilation.
Tidal Volume and Minute Ventilation (L)
Time frame: Within 24 hours prior to weaning from mechanical ventilation.
P0.1 (cmH2O)
Time frame: Within 24 hours prior to weaning from mechanical ventilation.
Dynamic Compliance (mL/cmH2O)
Time frame: Within 24 hours prior to weaning from mechanical ventilation.
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 27 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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 Weaning Failure of Mechanical Ventilation and Diaphragm Ultrasonography, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 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 27 Oct 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 Turkey (Türkiye). 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?
Diaphragm Thickness Measurement (time frame: Within 24 hours prior to weaning from mechanical ventilation.). The study lists 3 primary outcomes in all. 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 27 Oct 2026.