NCT07376525

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
Last Updated

July 21, 2026

Status Verified

July 1, 2026

Enrollment Period

1 month

First QC Date

January 22, 2026

Last Update Submit

July 19, 2026

Conditions

Keywords

Percutaneous Dilatational TracheostomyFiberoptic BronchoscopyUltrasonographyMechanical VentilationIntensive Care UnitArterial Blood GasVentilation Parameters

Outcome Measures

Primary Outcomes (1)

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

    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.

    Immediately before the procedure, during the procedure, and immediately after the procedure

Secondary Outcomes (2)

  • Procedure Duration

    During the procedure

  • Procedure-Related Complications

    During the procedure and the immediate post-procedural period

Study Arms (2)

Fiberoptic Bronchoscopy-Guided Percutaneous Dilatational Tracheostomy

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

Procedure: Percutaneous Dilatational Tracheostomy Guidance Method

Ultrasonography-Guided Percutaneous Dilatational Tracheostomy

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

Procedure: Percutaneous Dilatational Tracheostomy Guidance Method

Interventions

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

Fiberoptic Bronchoscopy-Guided Percutaneous Dilatational TracheostomyUltrasonography-Guided Percutaneous Dilatational Tracheostomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult intensive care unit patients who required prolonged invasive mechanical ventilation and underwent percutaneous dilatational tracheostomy guided by either fiberoptic bronchoscopy or ultrasonography as part of routine clinical practice.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Istanbul, Sisli, 34384, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Intensive Care Specialist

Study Record Dates

First Submitted

January 22, 2026

First Posted

January 29, 2026

Study Start

September 15, 2025

Primary Completion

October 15, 2025

Study Completion

October 15, 2025

Last Updated

July 21, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations