Ignite Creation Date:
2024-05-06 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05792098
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-04-11
First Post:
2023-03-07
Brief Title:
Percutaneous Dilatational Tracheostomy and Thyroid Isthmus Penetration
Sponsor:
Charles University Czech Republic
Organization:
Charles University Czech Republic
Study Overview
Official Title:
Percutaneous Dilatational Tracheostomy and Thyroid Isthmus Penetration
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PETRIS
Brief 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 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None