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临床试验/NCT07376525
NCT07376525已完成不适用

Comparison of the Effects of Percutaneous Dilatational Tracheostomy Performed With Fiberoptic Bronchoscopy and Ultrasound Guidance on Ventilation

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2025年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
77
试验地点
1
主要终点
Change in Ventilation and Arterial Blood Gas Parameters During Percutaneous Dilatational Tracheostomy

研究概览

简要总结

Percutaneous dilatational tracheostomy (PDT) is a commonly performed procedure in intensive care units for patients requiring prolonged mechanical ventilation. Fiberoptic bronchoscopy (FOB) and ultrasonography (USG) are frequently used to guide PDT in order to improve procedural safety. However, the effects of these guidance techniques on ventilation parameters during the procedure remain unclear.

This retrospective observational study aims to compare the effects of FOB-guided and USG-guided percutaneous dilatational tracheostomy on ventilation parameters in mechanically ventilated adult intensive care unit patients. Changes in arterial blood gas parameters and ventilator settings during and after the procedure will be evaluated.

The findings of this study may help clinicians better understand the physiological effects of different PDT guidance techniques and support informed decision-making in clinical practice.

详细描述

Percutaneous dilatational tracheostomy (PDT) is widely used in intensive care units (ICUs) as an alternative to surgical tracheostomy in patients requiring prolonged mechanical ventilation. Various guidance methods have been introduced to increase procedural safety and accuracy, including fiberoptic bronchoscopy (FOB) and ultrasonography (USG). While both techniques are commonly used, their effects on ventilation and gas exchange during the procedure are still debated.

Fiberoptic bronchoscopy allows direct visualization of the tracheal lumen and needle placement but may partially obstruct the airway, potentially leading to increased airway pressures, hypercapnia, and impaired ventilation. Ultrasonography, on the other hand, enables real-time visualization of neck anatomy without entering the airway and may therefore have different effects on ventilation parameters.

This retrospective observational study includes adult ICU patients who underwent percutaneous dilatational tracheostomy between May 5, 2023, and September 1, 2025. Patients were grouped according to the guidance technique used during the procedure: FOB-guided PDT or USG-guided PDT. All procedures were performed under standard ICU conditions by experienced clinicians.

Demographic data, clinical characteristics, ventilator settings, and arterial blood gas parameters were collected from patient records. Primary outcomes included changes in arterial blood gas values (pH, PaCO₂, PaO₂) and ventilatory parameters before, during, and after the procedure. Secondary outcomes included procedure duration and procedure-related complications.

The study aims to compare the effects of FOB-guided and USG-guided PDT on ventilation and gas exchange, providing insight into the physiological consequences of each technique. As a retrospective observational study, no additional interventions were performed beyond standard clinical practice.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • Adult patients (≥18 years of age)
  • Patients admitted to the intensive care unit
  • Patients receiving invasive mechanical ventilation
  • Patients who underwent percutaneous dilatational tracheostomy under fiberoptic bronchoscopy or ultrasonography guidance
  • Availability of complete clinical and arterial blood gas data

排除标准

  • Age <18 years
  • Patients with incomplete medical records or missing arterial blood gas data
  • Patients who underwent surgical (open) tracheostomy
  • Patients with pre-existing tracheal pathology affecting ventilation parameters

研究组 & 干预措施

Fiberoptic Bronchoscopy-Guided Percutaneous Dilatational Tracheostomy

Adult ICU patients who underwent percutaneous dilatational tracheostomy guided by fiberoptic bronchoscopy as part of routine clinical practice.

干预措施: Percutaneous Dilatational Tracheostomy Guidance Method (Procedure)

Ultrasonography-Guided Percutaneous Dilatational Tracheostomy

Adult ICU patients who underwent percutaneous dilatational tracheostomy guided by ultrasonography as part of routine clinical practice.

干预措施: Percutaneous Dilatational Tracheostomy Guidance Method (Procedure)

结局指标

主要结局

Change in Ventilation and Arterial Blood Gas Parameters During Percutaneous Dilatational Tracheostomy

时间窗: Immediately before the procedure, during the procedure, and immediately after the procedure

Changes in arterial blood gas parameters (pH, PaCO₂, PaO₂) and ventilatory parameters measured before, during, and after percutaneous dilatational tracheostomy, comparing fiberoptic bronchoscopy-guided and ultrasonography-guided procedures.

次要结局

  • Procedure Duration(During the procedure)
  • Procedure-Related Complications(During the procedure and the immediate post-procedural period)

研究者

发起方
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rabia Sarı Küçük

Intensive Care Specialist

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

研究点 (1)

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