Respiratory FailureNCT07376525
Comparison of Ventilatory Effects of Ultrasound-Guided Versus Bronchoscopy-Guided Percutaneous Dilatational Tracheostomy
An observational study of Respiratory Failure and Mechanical Ventilation, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Mechanical Ventilation, Tracheostomy
- What is being tested?
- Percutaneous Dilatational Tracheostomy Guidance Method
- Type of treatment
- Surgery or procedure
- How many people
- 77 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2025to 15 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Istanbul, Sisli, 34384
About this study
Official title: Comparison of the Effects of Percutaneous Dilatational Tracheostomy Performed With Fiberoptic Bronchoscopy and Ultrasound Guidance on Ventilation
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.
Read the detailed description
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.
- Conditions
- Respiratory Failure, Mechanical Ventilation, Tracheostomy
- Being tested
- Percutaneous Dilatational Tracheostomy Guidance Method
- Keywords
- Percutaneous Dilatational Tracheostomy, Fiberoptic Bronchoscopy, Ultrasonography, Mechanical Ventilation, Intensive Care Unit, Arterial Blood Gas, Ventilation Parameters
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Dilatational Tracheostomy Guidance MethodProcedure or surgery
Percutaneous dilatational tracheostomy performed under either fiberoptic bronchoscopy or ultrasonography guidance according to routine clinical practice. No interventions were assigned by study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Fiberoptic Bronchoscopy-Guided Percutaneous Dilatational Tracheostomy | Adult ICU patients who underwent percutaneous dilatational tracheostomy guided by fiberoptic bronchoscopy as part of routine clinical practice. Receives: 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. Receives: Procedure: Percutaneous Dilatational Tracheostomy Guidance Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately before the procedure, during the procedure, and immediately after the procedure
Secondary outcomes (2)
Procedure Duration
Total duration of the percutaneous dilatational tracheostomy procedure, measured from skin incision to successful tracheostomy tube placement.
Measured: During the procedure
Procedure-Related Complications
Incidence of procedure-related complications, including hypoxia, hypercapnia, bleeding, hypotension, pneumothorax, and other clinically relevant adverse events.
Measured: During the procedure and the immediate post-procedural period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start15 Sep 2025
- Primary completion15 Oct 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabia Sarı Küçük, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07376525
- Sponsor's protocol ID
- CT-ERHO-AR-BA-02
- Status last verified
- Jul 2026
- First submitted
- 22 Jan 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Percutaneous Dilatational Tracheostomy Performed With Fiberoptic Bronchoscopy and Ultrasound Guidance on Ventilation
- ClinicalTrials.gov ID
- NCT07376525
- Acronym / sponsor ID
- CT-ERHO-AR-BA-02
- Conditions
- Respiratory Failure, Mechanical Ventilation, Tracheostomy
- Keywords
- Percutaneous Dilatational Tracheostomy, Fiberoptic Bronchoscopy, Ultrasonography, Mechanical Ventilation, Intensive Care Unit, Arterial Blood Gas, Ventilation Parameters
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fiberoptic Bronchoscopy-Guided Percutaneous Dilatational Tracheostomy | – | Procedure: Percutaneous Dilatational Tracheostomy Guidance MethodAdult ICU patients who underwent percutaneous dilatational tracheostomy guided by fiberoptic bronchoscopy as part of routine clinical practice. |
| Ultrasonography-Guided Percutaneous Dilatational Tracheostomy | – | Procedure: Percutaneous Dilatational Tracheostomy Guidance MethodAdult ICU patients who underwent percutaneous dilatational tracheostomy guided by ultrasonography as part of routine clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Dilatational Tracheostomy Guidance MethodPercutaneous dilatational tracheostomy performed under either fiberoptic bronchoscopy or ultrasonography guidance according to routine clinical practice. No interventions were assigned by study protocol. | Procedure or surgery | Fiberoptic Bronchoscopy-Guided Percutaneous Dilatational Tracheostomy, Ultrasonography-Guided Percutaneous Dilatational Tracheostomy |
Primary outcome
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.
2 secondary outcomes
Procedure Duration
Time frame: During the procedure
Procedure-Related Complications
Time frame: During the procedure and the immediate post-procedural period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Failure and Mechanical Ventilation, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.