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Percutaneous Dilatational Tracheostomy and Thyroid Isthmus Penetration (PETRIS)

C

Charles University, Czech Republic

Status

Invitation-only

Conditions

Tracheostomy Complication

Treatments

Diagnostic Test: Ultrasound examination
Procedure: percutaneous dilatational tracheostomy (PDTS)
Diagnostic Test: Bronchoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT05792098
PETRIS_01

Details and patient eligibility

About

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).

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 18 Years and older
  • long-term need for mechanical ventilation

Exclusion criteria

  • not willing to participate

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

Standard procedure group
Active Comparator group
Description:
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.
Treatment:
Procedure: percutaneous dilatational tracheostomy (PDTS)
Diagnostic Test: Bronchoscopy
Ultrasound navigated group
Active Comparator group
Description:
Ultrasound navigated group, the attending physician will additionally use ultrasound navigation during the procedure.
Treatment:
Diagnostic Test: Ultrasound examination
Procedure: percutaneous dilatational tracheostomy (PDTS)
Diagnostic Test: Bronchoscopy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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