Namık Kemal University Hospital
Tekirdağ, 59020, Turkey (Türkiye)
NCT Number: NCT06967623
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.
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Notify Me18 year and older
All sexes
Observational
Tekirdağ, 59020, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Tarık Durna
Other
Comparison of the Effectiveness of Diaphragm Thickness in Indicating Weaning Success With Other Weaning Parameters in Patients Followed up in the Intensive Care ünit
Acronym: Weaning
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