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NCT Number: NCT07376525

Comparison of Ventilatory Effects of Ultrasound-Guided Versus Bronchoscopy-Guided Percutaneous Dilatational Tracheostomy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Istanbul, Sisli, 34384, Turkey (Türkiye)

About this study

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.

The results of this study may contribute to optimizing guidance method selection during percutaneous dilatational tracheostomy and improving patient safety in the intensive care setting.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Percutaneous Dilatational Tracheostomy Guidance Method

Procedure

Percutaneous dilatational tracheostomy performed under either fiberoptic bronchoscopy or ultrasonography guidance according to routine clinical practice. No interventions were assigned by study protocol.

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Procedure Duration

    Time frame: During the procedure

    Total duration of the percutaneous dilatational tracheostomy procedure, measured from skin incision to successful tracheostomy tube placement.

  2. Procedure-Related Complications

    Time frame: During the procedure and the immediate post-procedural period

    Incidence of procedure-related complications, including hypoxia, hypercapnia, bleeding, hypotension, pneumothorax, and other clinically relevant adverse events.

Sponsors and collaborators

Lead sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 29, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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