Tracheostomy ComplicationPETRISNCT05792098
Percutaneous Dilatational Tracheostomy and Thyroid Isthmus Penetration
A study testing percutaneous dilatational tracheostomy (PDTS), Ultrasound examination and Bronchoscopy in people with Tracheostomy Complication, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
A prospective randomized interventional study will be conducted in the Military University Hospital Prague at the department of Anesthesiology and Intensive care. The incidence of thyroid isthmus penetration will be evaluated during percutaneous dilatational tracheostomy in two groups (ultrasound-guided puncture vs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheostomy Complication
- What is being tested?
- percutaneous dilatational tracheostomy (PDTS), Ultrasound examination and Bronchoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCzechia
- Study dates
- 6 Apr 2023to 12 Dec 2025
- Phase
- Interventional
- 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
Who may be able to join
- 18 Years and older
- long-term need for mechanical ventilation
Who cannot join
- not willing to participate
Trial locations and contacts
1 site in 1 country.
About this study
A prospective randomized interventional study will be conducted in the Military University Hospital Prague at the department of Anesthesiology and Intensive care. The incidence of thyroid isthmus penetration will be evaluated during percutaneous dilatational tracheostomy in two groups (ultrasound-guided puncture vs. standard approach using only anatomical landmarks).
Read the detailed description
A prospective randomized interventional study will be conducted in the Military University Hospital Prague at the department of Anesthesiology and Intensive care. Patients indicated by the attending physician to percutaneous dilatational tracheostomy (PDTS) due to long-term need for mechanical ventilation will be randomly divided into two groups. The standard procedure group will undergo PDTS by the attending physician in the standard manner based on clinical examination and anatomical landmarks using bronchoscopic navigation. In the second group, the attending physician will additionally use ultrasound navigation during the procedure. After insertion of the guidewire, before dilation is performed, patients in both groups will be examined by ultrasound by an independent physician - the study investigator - who will verify the position of the guidewire and its relationship to the surrounding structures. In case of malposition of the guidewire (unacceptable lateral or craniocaudal), the penetration site will be adjusted and the PDTS completed.
- Conditions
- Tracheostomy Complication
- Being tested
- percutaneous dilatational tracheostomy (PDTS), Ultrasound examination, Bronchoscopy
- Keywords
- percutaneous dilatational tracheostomy, ultrasound, mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous dilatational tracheostomy (PDTS)Procedure or surgery
Tracheostomy made by percutaneous dilatational technique
Ultrasound examinationDiagnostic test
Ultrasound verification of guidewire position
BronchoscopyDiagnostic test
Bronchoscopic control of guidewire position
| Study group | Role | What they receive |
|---|---|---|
| Standard procedure group | Active comparator | The standard procedure group will undergo PDTS by the attending physician in the standard manner based on clinical examination and anatomical landmarks using bronchoscopic control. Receives: Procedure: percutaneous dilatational tracheostomy (PDTS); Diagnostic Test: Bronchoscopy |
| Ultrasound navigated group | Active comparator | Ultrasound navigated group, the attending physician will additionally use ultrasound navigation during the procedure. Receives: Procedure: percutaneous dilatational tracheostomy (PDTS); Diagnostic Test: Ultrasound examination; Diagnostic Test: Bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The guidewire penetration through the thyroid isthmus.
Incidence of guidewire penetration through the thyroid isthmus in standard and ultrasound navigated percutaneous dilatational tracheostomy.
Measured: During procedure
Monitoring the incidence of early postoperative complications.
The incidence of bleeding from tracheostomy canal during hospitalization depending on guidewire position, defined as the need for any intervention to stop the bleeding.
The incidence of tracheostomy canal infection during hospitalization depending on guidewire position, defined as the presence of any clinical signs of inflammation (swelling, redness, pain, secretion production, dehiscence).
Measured: Up to 10 days
Secondary outcomes (1)
Using ultrasound examination as a tool for PDTS navigation in terms of correct puncture site.
Monitoring the frequency of guidewire position changes based on ultrasound examination.
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start6 Apr 2023
- Primary completion1 Apr 2025 (estimated)
- Study completion12 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tracheostomy ComplicationStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Military University Hospital, Prague
- Responsible party
- Sponsor
- Investigators
- Ilona Trtíková, Mgr., Ph.D., Study chair, CHARLES UNIVERSITY, FIRST FACULTY OF MEDICINE AND GENERAL UNIVERSITY HOSPITAL IN PRAGUE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05792098
- Sponsor's protocol ID
- PETRIS_01
- Acronym
- PETRIS
- Status last verified
- Mar 2023
- First submitted
- 7 Mar 2023
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gobatto ALN, Besen BAMP, Tierno PFGMM, Mendes PV, Cadamuro F, Joelsons D, Melro L, Carmona MJC, Santori G, Pelosi P, Park M, Malbouisson LMS. Ultrasound-guided percutaneous dilational tracheostomy versus bronchoscopy-guided percutaneous dilational tracheostomy in critically ill patients (TRACHUS): a randomized noninferiority controlled trial. Intensive Care Med. 2016 Mar;42(3):342-351. doi: 10.1007/s00134-016-4218-6. Epub 2016 Feb 1.
PubMed 26831676Plata P, Gaszynski T. Ultrasound-guided percutaneous tracheostomy. Anaesthesiol Intensive Ther. 2019;51(2):126-132. doi: 10.5114/ait.2019.86277.
PubMed 31268274Rara A, Sotak M, Hynek M, Kovacic K, Filipovsky T, Tyll T. Percutaneous dilatational tracheostomy and thyroid isthmus penetration (PETRIS). Anaesth Crit Care Pain Med. 2026 May 30;45(6):101863. doi: 10.1016/j.accpm.2026.101863. Online ahead of print.
PubMed 42217576
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Dilatational Tracheostomy and Thyroid Isthmus Penetration
- ClinicalTrials.gov ID
- NCT05792098
- Acronym / sponsor ID
- PETRIS / PETRIS_01
- Conditions
- Tracheostomy Complication
- Keywords
- percutaneous dilatational tracheostomy, ultrasound, mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- Military University Hospital, Prague
- Study start
- 6 Apr 2023 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 12 Dec 2025 (estimated)
- First posted
- 30 Mar 2023 (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.
A prospective randomized interventional study will be conducted in the Military University Hospital Prague at the department of Anesthesiology and Intensive care. The incidence of thyroid isthmus penetration will be evaluated during percutaneous dilatational tracheostomy in two groups (ultrasound-guided puncture vs. standard approach using only anatomical landmarks).
Detailed description
A prospective randomized interventional study will be conducted in the Military University Hospital Prague at the department of Anesthesiology and Intensive care. Patients indicated by the attending physician to percutaneous dilatational tracheostomy (PDTS) due to long-term need for mechanical ventilation will be randomly divided into two groups. The standard procedure group will undergo PDTS by the attending physician in the standard manner based on clinical examination and anatomical landmarks using bronchoscopic navigation. In the second group, the attending physician will additionally use ultrasound navigation during the procedure. After insertion of the guidewire, before dilation is performed, patients in both groups will be examined by ultrasound by an independent physician - the study investigator - who will verify the position of the guidewire and its relationship to the surrounding structures. In case of malposition of the guidewire (unacceptable lateral or craniocaudal), the penetration site will be adjusted and the PDTS completed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard procedure group | Active comparator | Procedure: percutaneous dilatational tracheostomy (PDTS), Diagnostic Test: BronchoscopyThe standard procedure group will undergo PDTS by the attending physician in the standard manner based on clinical examination and anatomical landmarks using bronchoscopic control. |
| Ultrasound navigated group | Active comparator | Procedure: percutaneous dilatational tracheostomy (PDTS), Diagnostic Test: Ultrasound examination, Diagnostic Test: BronchoscopyUltrasound navigated group, the attending physician will additionally use ultrasound navigation during the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 Years and older
- long-term need for mechanical ventilation
Key exclusion criteria (1 listed)
- not willing to participate
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 (PDTS)Tracheostomy made by percutaneous dilatational technique | Procedure or surgery | Standard procedure group, Ultrasound navigated group |
| Ultrasound examinationUltrasound verification of guidewire position | Diagnostic test | Ultrasound navigated group |
| BronchoscopyBronchoscopic control of guidewire position | Diagnostic test | Standard procedure group, Ultrasound navigated group |
Primary outcome
The guidewire penetration through the thyroid isthmus.
Time frame: During procedure
Incidence of guidewire penetration through the thyroid isthmus in standard and ultrasound navigated percutaneous dilatational tracheostomy.
Monitoring the incidence of early postoperative complications.
Time frame: Up to 10 days
The incidence of bleeding from tracheostomy canal during hospitalization depending on guidewire position, defined as the need for any intervention to stop the bleeding. The incidence of tracheostomy canal infection during hospitalization depending on guidewire position, defined as the presence of any clinical signs of inflammation (swelling, redness, pain, secretion production, dehiscence).
1 secondary outcome
Using ultrasound examination as a tool for PDTS navigation in terms of correct puncture site.
Time frame: During procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Background: PubMed 26831676Gobatto ALN, Besen BAMP, Tierno PFGMM, Mendes PV, Cadamuro F, Joelsons D, Melro L, Carmona MJC, Santori G, Pelosi P, Park M, Malbouisson LMS. Ultrasound-guided percutaneous dilational tracheostomy versus bronchoscopy-guided percutaneous dilational tracheostomy in critically ill patients (TRACHUS): a randomized noninferiority controlled trial. Intensive Care Med. 2016 Mar;42(3):342-351. doi: 10.1007/s00134-016-4218-6. Epub 2016 Feb 1.
- Background: PubMed 31268274Plata P, Gaszynski T. Ultrasound-guided percutaneous tracheostomy. Anaesthesiol Intensive Ther. 2019;51(2):126-132. doi: 10.5114/ait.2019.86277.
- Derived from this study: PubMed 42217576Rara A, Sotak M, Hynek M, Kovacic K, Filipovsky T, Tyll T. Percutaneous dilatational tracheostomy and thyroid isthmus penetration (PETRIS). Anaesth Crit Care Pain Med. 2026 May 30;45(6):101863. doi: 10.1016/j.accpm.2026.101863. Online ahead of print.
- 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.
Ilona Trtíková, Mgr., Ph.D. study chair
CHARLES UNIVERSITY, FIRST FACULTY OF MEDICINE AND GENERAL UNIVERSITY HOSPITAL IN PRAGUE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing percutaneous dilatational tracheostomy (PDTS), Ultrasound examination and Bronchoscopy in people with Tracheostomy Complication, run by Charles University, Czech Republic at 1 site in Czechia.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Apr 2023. 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 Czechia. 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?
Results are not available in the source record.
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?
The guidewire penetration through the thyroid isthmus. (time frame: During procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05792098, which also lists 3 linked publications.
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 11 Apr 2023; AzTrials last refreshed its copy on 6 Nov 2026.