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临床试验/NCT07523828
NCT07523828尚未招募不适用

The Relationship Between Assessment of Laryngeal Edema in Intensive Care Patients Using Cuff Leak Test and Ultrasound-Guided Laryngeal Air Column Width Difference and Weaning Success

Fatih Sultan Mehmet Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年4月8日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Can pre-weaning laryngeal edema be used to predict weaning success?

研究概览

简要总结

This study evaluates laryngeal edema in ICU patients during weaning from mechanical ventilation. It compares the cuff leak test and ultrasound-based laryngeal air column measurements in predicting weaning success. Ultrasound offers a non-invasive and real-time alternative for airway assessment. The study also examines post-extubation complications such as stridor, sore throat, dysphonia, and dysphagia.

详细描述

Endotracheal intubation is one of the life-saving procedures used to support the respiratory system of critically ill patients on mechanical ventilation. In intubated patients, mechanical ventilation support is frequently applied in conditions such as acute respiratory failure or acute exacerbation of chronic respiratory failure where adequate oxygenation and/or ventilation cannot be achieved, loss of consciousness or airway reflexes, upper airway obstruction, and advanced life support in cardiac arrest; with the aim of improving gas exchange, reducing the work of breathing, or maintaining airway patency (1).

Airway complications may occur as a result of mechanical effects such as friction between the endotracheal tube and anatomical structures and prolonged compression. Prolonged intubation may cause partial airway obstruction, which can lead to laryngeal edema and post-extubation stridor (2). In patients receiving mechanical ventilation for 4 days or longer, mucosal ulcerations and laryngeal edema can be observed in almost all cases (3). Factors associated with post-extubation edema include advanced age, female gender, endotracheal tube size, presence of a cuffed endotracheal tube, prolonged duration of intubation, underlying airway disease, traumatic intubation, tracheal aspiration, tube mobility, and patient resistance to the tube (4). This may lead to sore throat, cough, dysphonia, dysphagia, and even respiratory failure requiring reintubation due to airway narrowing. Consequently, laryngeal edema in intensive care units (ICUs) is associated with longer durations of mechanical ventilation, increased hospital stay, higher morbidity and mortality, and significant economic costs (5).

"Weaning" is defined as the gradual reduction and discontinuation of mechanical ventilation support (6). The weaning process begins with the resolution of the cause of respiratory failure and results in the patient eventually breathing spontaneously. Weaning trials may fail due to increased work of breathing, laryngeal edema caused by prolonged intubation, electrolyte imbalances, malnutrition, hypothyroidism, major organ failure, and critical illness neuropathy (6).

Laryngeal edema causing post-extubation respiratory distress is usually the result of edema in the subglottic region and vocal cords (7). Examination of the vocal cords is typically performed using direct or indirect laryngoscopy. However, the presence of the endotracheal tube before extubation prevents direct visualization of the upper airway, making it difficult to detect laryngotracheal injury and edema.

The endotracheal tube cuff leak test is one of the most commonly used non-invasive and easily applicable bedside methods to assess airway anatomy and patency before extubation (6,8).

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

入选标准

  • Patients who have been intubated and receiving invasive mechanical ventilation for at least 24 hours in the Intensive Care Unit of Fatih Sultan Mehmet Training and Research Hospital and who are considered by the intensive care physician to be ready for weaning from mechanical ventilation:
  • Patients over 18 years of age
  • Patients who have given their voluntary consent

排除标准

  • Patients under 18 years of age
  • Patients with a history of oral cavity surgery such as direct laryngoscopy and biopsy, microlaryngoscopic surgery, tonsillectomy, adenoidectomy, soft palate, oropharynx, hypopharynx, larynx and trachea,
  • Patients with a history of allergy, asthma, reflux, upper respiratory tract viral or fungal infections, and cancer surgery,
  • Patients who received radiotherapy to the neck region, or who had more than one intubation attempt in the previous year,
  • Tracheostomized patients, patients with upper respiratory tract obstruction, vocal cord paralysis, and patients with stridor clinical picture before intubation,
  • Patients for whom voluntary consent cannot be obtained

研究组 & 干预措施

Patients intubated for ≥24 hours in the ICU and undergoing weaning, evaluated with cuff leak test an

Patients intubated for ≥24 hours in the ICU and undergoing weaning, evaluated with cuff leak test and airway ultrasound before extubation.

结局指标

主要结局

Can pre-weaning laryngeal edema be used to predict weaning success?

时间窗: Within 24 hours prior to extubation and during the weaning process

To evaluate whether laryngeal edema measured prior to weaning can predict weaning success in mechanically ventilated ICU patients.

次要结局

未报告次要终点

研究者

发起方
Fatih Sultan Mehmet Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Büşra Şimşek Ersöz

RESIDENT DOCTOR

Fatih Sultan Mehmet Training and Research Hospital

研究点 (1)

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