NCT05514613

Brief Summary

This study aims to assess the impact of real-time ultrasound (US) use on complication rates and procedural success in percutaneous dilational tracheostomy (PDT) opened with forceps dilatation technique using anatomical landmarks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2019

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2019

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 24, 2022

Completed
Last Updated

August 24, 2022

Status Verified

August 1, 2022

Enrollment Period

10 months

First QC Date

August 9, 2022

Last Update Submit

August 22, 2022

Conditions

Tracheostomy Complication

Keywords

ultrasound guided tracheostomyanatomic landmark tracheostomytracheostomycomplications

Outcome Measures

Primary Outcomes (1)

  • Ultrasound-guided Tracheostomy and Landmark Percutaneous Dilatational Tracheostomy

    the relationship of complications with the tracheostomy technique

    01.04.2017-11.03.2019

Study Arms (2)

Group G

Group G is a tracheostomy group opened using the anatomical sign technique (Griggs technique).

Other: retrospektif study; The effect of tracheostomy tecnique method on complications

Group U

Group U; Ultrasound-guided is used during tracheostomy technique.

Other: retrospektif study; The effect of tracheostomy tecnique method on complications

Interventions

retrospektif study; The effect of tracheostomy tecnique method on complicationsOTHER

retrospektif study; The effect of tracheostomy tecnique method on complications complications and correlation of complications with techniques

Group GGroup U

Eligibility Criteria

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

Patients over the age of 18 who were hospitalized in the intensive care unit and underwent tracheostomy

You may qualify if:

  • Hospitalized in the intensive care unit and tracheostomy was opened and over 18 years.

You may not qualify if:

  • surgical opened tracheostomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Çorum training and research state hospital

Çorum, 19030, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant professor doctor Hulya TOPCU

Study Record Dates

First Submitted

August 9, 2022

First Posted

August 24, 2022

Study Start

January 1, 2019

Primary Completion

November 10, 2019

Study Completion

December 22, 2021

Last Updated

August 24, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)