Comparison of Weaning Parameters and Diaphragm Thickness Changes (NCT06967623) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Weaning Parameters and Diaphragm Thickness Changes
Turkey (Türkiye)90 participantsStarted 2022-07-15
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 par…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Diaphragm Thickness
Timeframe: From Day 1 of mechanical ventilation to the day of planned extubation, up to 14 days
2
Number of Participants with Successful Weaning (Maintaining Spontaneous Breathing for ≥48 Hours Post-Extubation)