Mechanical VentilationWeaningNCT06967623
Comparison of Weaning Parameters and Diaphragm Thickness Changes
An observational study of Mechanical Ventilation and Weaning Failure, run by Tarık Durna at 1 site in Turkey (Türkiye).
Trial summary
Determining the appropriate timing for mechanical ventilator weaning in intensive care unit patients is critical to avoid complications related to early or late weaning, including weaning failure. Common predictors such as P0.1, F/VT, WOB, and P0.1 × F/VT are routinely used to guide this decision. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation, Weaning Failure, Intensive Care Unit (ICU) Patients
- What is being tested?
- diaphragm ultrasound
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2022to 15 Jan 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: The study will include 68 adult participants (18+ years) who are intubated and undergoing mechanical ventilation for at least 24 hours in an ICU. Inclusion Criteria: Intubated for 24+ hours, Glasgow Coma Scale (GCS) > 8, BMI < 35, meets weaning criteria, willing to consent. Exclusion Criteria: Age < 18, severe cognitive or neurological impairment, ventilation < 24 hours, severe comorbidities, pregnancy/breastfeeding, contraindications for diaphragm ultrasound. Population Characteristics: The cohort will consist of ICU patients being evaluated for weaning, representing a range of ages, genders, and comorbidities. Demographic and clinical data will be analyzed for correlations with diaphragm thickness change and weaning success. Study Design: An observational cohort study using ultrasound to assess diaphragm thickness in relation to mechanical ventilation weaning outcomes.
Who may be able to join
- Age: Participants aged 18 years or older.
- Intubation Status: Participants who are intubated and receiving mechanical ventilation for at least 24 hours.
- Glasgow Coma Scale (GCS): Participants with a GCS score of greater than 8 at the time of enrollment.
- Body Mass Index (BMI): Participants with a BMI lower than 35.
- Weaning Suitability: Participants who are being evaluated for weaning from mechanical ventilation based on routine ICU weaning parameters.
- Informed Consent: Participants or their legal representatives must provide informed consent to participate in the study.
Who cannot join
- Age: Participants younger than 18 years.
- Neurological or Cognitive Impairments: Participants with neurological or cognitive conditions that may affect the ability to participate in the study or give informed consent.
- Mechanical Ventilation Duration: Participants who have been on mechanical ventilation for less than 24 hours at the time of enrollment.
- Severe Respiratory Conditions: Participants with conditions such as acute respiratory distress syndrome (ARDS) or those requiring higher levels of respiratory support, such as invasive or non-invasive positive pressure ventilation.
- Severe Heart Failure: Participants with severe heart failure or other critical cardiovascular conditions that may interfere with the ability to tolerate weaning procedures.
- Pregnancy: Female participants who are pregnant or breastfeeding.
- Other Contraindications: Any participant for whom diaphragm ultrasound measurements would be technically difficult or clinically inappropriate (e.g., due to anatomical or technical factors).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Namık Kemal University Hospital
Tekirdağ, 59020
About this study
Official title: Comparison of the Effectiveness of Diaphragm Thickness in Indicating Weaning Success With Other Weaning Parameters in Patients Followed up in the Intensive Care ünit
Determining the appropriate timing for mechanical ventilator weaning in intensive care unit patients is critical to avoid complications related to early or late weaning, including weaning failure. Common predictors such as P0.1, F/VT, WOB, and P0.1 × F/VT are routinely used to guide this decision. Recently, diaphragm muscle weakness has been recognized as a significant contributor to weaning failure. Ultrasound has emerged as a useful, repeatable, and non-invasive tool for assessing diaphragmatic function.
This study investigates the relationship between ultrasound-based diaphragm thickness changes and standard weaning predictors. It also evaluates the impact of demographic variables such as age, gender, weight, and comorbidities on diaphragm thickness. A total of 68 mechanically ventilated patients, aged 18 years or older, with Glasgow Coma Scale >8 and BMI <35, were included. Ultrasound measurements were performed on the first day of intubation and prior to extubation, using a high-frequency linear probe from the right anterior mid-axillary line at the 8th-10th rib level. Weaning was considered successful if patients maintained spontaneous breathing for 48 hours post-extubation.
Read the detailed description
Study Title: The Relationship between Diaphragm Thickness Changes and Weaning Predictors in Intensive Care Unit Patients on Mechanical Ventilation
Background: Mechanical ventilation weaning, or transitioning patients from mechanical ventilators to spontaneous breathing, is a critical step in intensive care. The decision on the optimal timing of weaning is pivotal for patient recovery and minimizing complications. Early or delayed weaning may lead to failure, which significantly increases mortality and morbidity rates. Traditional weaning predictors such as P0.1, F/VT, WOB, and P0.1 X F/VT are widely used in intensive care units (ICUs), but none provide a comprehensive assessment of diaphragmatic function.
Recent studies have indicated diaphragm weakness as a potential major cause of weaning failure, and ultrasonography of the diaphragm has gained attention as a practical, reliable, and cost-effective diagnostic tool. Given its growing popularity, we aimed to assess the relationship between changes in diaphragm thickness-measured using ultrasound-and conventional weaning predictors in ICU patients.
Study Objective: The primary goal of the study was to observe the relationship between diaphragm thickness changes and conventional weaning parameters. Additionally, the study aimed to statistically investigate the effects of demographic variables such as age, gender, weight, and comorbidities on diaphragm thickness change and its potential implications for weaning success.
Methodology:
Study Design: A prospective observational study.
Study Population: 68 ICU patients, aged 18 years or older, who were intubated, had a Glasgow Coma Scale higher than 8, and had been on mechanical ventilation for at least 24 hours. Patients with a BMI greater than 35 were excluded.
Inclusion Criteria: Patients who met the weaning criteria and who had consented to participate in the study.
Exclusion Criteria: Patients with major contraindications to ultrasound (e.g., open chest surgery), or those with known neuromuscular disorders.
Ultrasonographic Measurements: On the first day of intubation or admission, diaphragm thickness was measured at the 8th and 10th ribs from the right anterior mid-axillary line using a high-frequency linear probe in B mode. Three repetitions were performed for each measurement, and the average was recorded. The second diaphragm thickness measurement was taken just before extubation in patients assessed as suitable for weaning.
Weaning Process: Weaning was attempted in patients who met routine criteria, including stable respiratory parameters (RSBI, P0.1, WOB, etc.). After weaning, the patients were extubated and observed for 48 hours. Those who maintained spontaneous breathing were considered successful weaning cases, while those who required reintubation were categorized as weaning failures.
Statistical Analysis: The statistical analysis focused on comparing the initial and final diaphragm thickness between the weaning success and failure groups. Additionally, the correlation between diaphragm thickness change and the duration of mechanical ventilation was explored. Multivariate regression models were used to adjust for potential confounding factors, including age, gender, weight, and comorbidities.
- Conditions
- Mechanical Ventilation, Weaning Failure, Intensive Care Unit (ICU) Patients, Diaphragm Dysfunction
- Being tested
- diaphragm ultrasound
- Keywords
- Diaphragm ultrasonography, Mechanical ventilation, Diaphragm thickness, Weaning, Weaning parameters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diaphragm ultrasoundDevice
On the day of hospitalization or the first day of mechanical ventilation, the patient's position was elevated by 30°, and the high-frequency linear probe of the ultrasound was placed perpendicular to the skin in the cranio-caudal direction, and the diaphragm apposition zone, where the right anterior and middle axillary line corresponds to the 8th-10th intercostal space, was imaged and measurements were made with B mode.
| Study group | Role | What they receive |
|---|---|---|
| weaning successful | Patients who can maintain spontaneous breathing for 48 hours Receives: Device: diaphragm ultrasound | |
| weaning failed | Patients who have failed spontaneous breathing attempts or require intubation within 48 hours after extubation Receives: Device: diaphragm ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Diaphragm Thickness
The primary outcome of the study will be the change in diaphragm thickness, measured using ultrasound before and after extubation.
Measured: From Day 1 of mechanical ventilation to the day of planned extubation, up to 14 days
Number of Participants with Successful Weaning (Maintaining Spontaneous Breathing for ≥48 Hours Post-Extubation)
Weaning success will be defined as the patient's ability to maintain spontaneous breathing without the need for reintubation or mechanical ventilatory support for at least 48 hours following extubation. Participants who require reintubation or ventilatory assistance within 48 hours will be considered as weaning failures.
Measured: Up to 48 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start15 Jul 2022
- Primary completion15 Jan 2024
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarık Durna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tarık Durna, Namik Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06967623
- Sponsor's protocol ID
- 2022.111.06.01
- Other IDs
- tarık durna
- Acronym
- Weaning
- Status last verified
- May 2025
- First submitted
- 24 Mar 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share individual participant data (IPD) with other researchers. Access to the data will be restricted to the study team for the purposes of this research only, in compliance with ethical and regulatory guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Diaphragm Thickness in Indicating Weaning Success With Other Weaning Parameters in Patients Followed up in the Intensive Care ünit
- ClinicalTrials.gov ID
- NCT06967623
- Acronym / sponsor ID
- Weaning / 2022.111.06.01
- Conditions
- Mechanical Ventilation, Weaning Failure, Intensive Care Unit (ICU) Patients, Diaphragm Dysfunction
- Keywords
- Diaphragm ultrasonography, Mechanical ventilation, Diaphragm thickness, Weaning, Weaning parameters
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tarık DurnaUniversity, hospital or other
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 13 May 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.
Determining the appropriate timing for mechanical ventilator weaning in intensive care unit patients is critical to avoid complications related to early or late weaning, including weaning failure. Common predictors such as P0.1, F/VT, WOB, and P0.1 × F/VT are routinely used to guide this decision. Recently, diaphragm muscle weakness has been recognized as a significant contributor to weaning failure. Ultrasound has emerged as a useful, repeatable, and non-invasive tool for assessing diaphragmatic function.
This study investigates the relationship between ultrasound-based diaphragm thickness changes and standard weaning predictors. It also evaluates the impact of demographic variables such as age, gender, weight, and comorbidities on diaphragm thickness. A total of 68 mechanically ventilated patients, aged 18 years or older, with Glasgow Coma Scale >8 and BMI <35, were included. Ultrasound measurements were performed on the first day of intubation and prior to extubation, using a high-frequency linear probe from the right anterior mid-axillary line at the 8th-10th rib level. Weaning was considered successful if patients maintained spontaneous breathing for 48 hours post-extubation.
Detailed description
Study Title: The Relationship between Diaphragm Thickness Changes and Weaning Predictors in Intensive Care Unit Patients on Mechanical Ventilation
Background: Mechanical ventilation weaning, or transitioning patients from mechanical ventilators to spontaneous breathing, is a critical step in intensive care. The decision on the optimal timing of weaning is pivotal for patient recovery and minimizing complications. Early or delayed weaning may lead to failure, which significantly increases mortality and morbidity rates. Traditional weaning predictors such as P0.1, F/VT, WOB, and P0.1 X F/VT are widely used in intensive care units (ICUs), but none provide a comprehensive assessment of diaphragmatic function.
Recent studies have indicated diaphragm weakness as a potential major cause of weaning failure, and ultrasonography of the diaphragm has gained attention as a practical, reliable, and cost-effective diagnostic tool. Given its growing popularity, we aimed to assess the relationship between changes in diaphragm thickness-measured using ultrasound-and conventional weaning predictors in ICU patients.
Study Objective: The primary goal of the study was to observe the relationship between diaphragm thickness changes and conventional weaning parameters. Additionally, the study aimed to statistically investigate the effects of demographic variables such as age, gender, weight, and comorbidities on diaphragm thickness change and its potential implications for weaning success.
Methodology:
Study Design: A prospective observational study.
Study Population: 68 ICU patients, aged 18 years or older, who were intubated, had a Glasgow Coma Scale higher than 8, and had been on mechanical ventilation for at least 24 hours. Patients with a BMI greater than 35 were excluded.
Inclusion Criteria: Patients who met the weaning criteria and who had consented to participate in the study.
Exclusion Criteria: Patients with major contraindications to ultrasound (e.g., open chest surgery), or those with known neuromuscular disorders.
Ultrasonographic Measurements: On the first day of intubation or admission, diaphragm thickness was measured at the 8th and 10th ribs from the right anterior mid-axillary line using a high-frequency linear probe in B mode. Three repetitions were performed for each measurement, and the average was recorded. The second diaphragm thickness measurement was taken just before extubation in patients assessed as suitable for weaning.
Weaning Process: Weaning was attempted in patients who met routine criteria, including stable respiratory parameters (RSBI, P0.1, WOB, etc.). After weaning, the patients were extubated and observed for 48 hours. Those who maintained spontaneous breathing were considered successful weaning cases, while those who required reintubation were categorized as weaning failures.
Statistical Analysis: The statistical analysis focused on comparing the initial and final diaphragm thickness between the weaning success and failure groups. Additionally, the correlation between diaphragm thickness change and the duration of mechanical ventilation was explored. Multivariate regression models were used to adjust for potential confounding factors, including age, gender, weight, and comorbidities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| weaning successful | – | Device: diaphragm ultrasoundPatients who can maintain spontaneous breathing for 48 hours |
| weaning failed | – | Device: diaphragm ultrasoundPatients who have failed spontaneous breathing attempts or require intubation within 48 hours after extubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include 68 adult participants (18+ years) who are intubated and undergoing mechanical ventilation for at least 24 hours in an ICU. Inclusion Criteria: Intubated for 24+ hours, Glasgow Coma Scale (GCS) > 8, BMI < 35, meets weaning criteria, willing to consent. Exclusion Criteria: Age < 18, severe cognitive or neurological impairment, ventilation < 24 hours, severe comorbidities, pregnancy/breastfeeding, contraindications for diaphragm ultrasound. Population Characteristics: The cohort will consist of ICU patients being evaluated for weaning, representing a range of ages, genders, and comorbidities. Demographic and clinical data will be analyzed for correlations with diaphragm thickness change and weaning success. Study Design: An observational cohort study using ultrasound to assess diaphragm thickness in relation to mechanical ventilation weaning outcomes.
Key inclusion criteria (6 listed)
- Age: Participants aged 18 years or older.
- Intubation Status: Participants who are intubated and receiving mechanical ventilation for at least 24 hours.
- Glasgow Coma Scale (GCS): Participants with a GCS score of greater than 8 at the time of enrollment.
- Body Mass Index (BMI): Participants with a BMI lower than 35.
- Weaning Suitability: Participants who are being evaluated for weaning from mechanical ventilation based on routine ICU weaning parameters.
Key exclusion criteria (7 listed)
- Age: Participants younger than 18 years.
- Neurological or Cognitive Impairments: Participants with neurological or cognitive conditions that may affect the ability to participate in the study or give informed consent.
- Mechanical Ventilation Duration: Participants who have been on mechanical ventilation for less than 24 hours at the time of enrollment.
- Severe Respiratory Conditions: Participants with conditions such as acute respiratory distress syndrome (ARDS) or those requiring higher levels of respiratory support, such as invasive or non-invasive positive pressure ventilation.
- Severe Heart Failure: Participants with severe heart failure or other critical cardiovascular conditions that may interfere with the ability to tolerate weaning procedures.
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 |
|---|---|---|
| diaphragm ultrasoundOn the day of hospitalization or the first day of mechanical ventilation, the patient's position was elevated by 30°, and the high-frequency linear probe of the ultrasound was placed perpendicular to the skin in the cranio-caudal direction, and the diaphragm apposition zone, where the right anterior and middle axillary line corresponds to the 8th-10th intercostal space, was imaged and measurements were made with B mode. | Device | weaning failed, weaning successful |
Primary outcome
Change in Diaphragm Thickness
Time frame: From Day 1 of mechanical ventilation to the day of planned extubation, up to 14 days
The primary outcome of the study will be the change in diaphragm thickness, measured using ultrasound before and after extubation.
Number of Participants with Successful Weaning (Maintaining Spontaneous Breathing for ≥48 Hours Post-Extubation)
Time frame: Up to 48 hours after extubation
Weaning success will be defined as the patient's ability to maintain spontaneous breathing without the need for reintubation or mechanical ventilatory support for at least 48 hours following extubation. Participants who require reintubation or ventilatory assistance within 48 hours will be considered as weaning failures.
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 13 May 2025.
- Individual participant dataSharing planned: No. We do not plan to share individual participant data (IPD) with other researchers. Access to the data will be restricted to the study team for the purposes of this research only, in compliance with ethical and regulatory guidelines.
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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 Mechanical Ventilation and Weaning Failure, run by Tarık Durna 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 6 inclusion and 7 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 13 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 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?
Change in Diaphragm Thickness (time frame: From Day 1 of mechanical ventilation to the day of planned extubation, up to 14 days). The study lists 2 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 13 May 2025.