Comparison of the Effectiveness of Diaphragm Thickness in Indicating Weaning Success With Other Weaning Parameters in Patients Followed up in the Intensive Care ünit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in Diaphragm Thickness
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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).
结局指标
主要结局
Change in Diaphragm Thickness
时间窗: 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)
时间窗: 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.
次要结局
未报告次要终点
研究者
Tarık Durna
Medical Doctor
Namik Kemal University