Ultrasound Guided Percutaneous Tracheostomy

January 30, 2017 updated by: ILKE KUPELI, Erzincan University

Comparison of 3 Techniques for Percutaneous Tracheostomy : Traditional Marking Technique, Ultrasonography Guided Long Axis Approach and Short Axis Approach

Use of the ultrasound before, during and after percutaneous tracheostomy allows us great advantages; anatomy of the pre and paratracheal region and displaying potential aberrant vessels, and so the needle and dilator to move away from risk areas and ensure the prevention of possible vascular complications. Measuring the distance from the skin into the trachea can be done and this allows us to choose the average size tracheostomy tube.

The aim of this study, In the process of applying percutaneous tracheostomy, to compare the reliability of the traditional landmark method, ultrasound-guided long axis in plane application and ultrasound-guided short axis out of plane application.

Study Overview

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • hospitalized patients in intensive care
  • the decision to open percutaneous tracheostomy
  • over 18 years

Exclusion Criteria:

  • under 18 years
  • Patients with high or unstable intracranial pressure
  • Patients with severe coagulation disorders
  • Patients attached collar
  • hemodynamically unstable patients, despite the use of high doses of vasoactive drugs
  • patients with infections in tracheostomy area

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: landmark group
percutaneous tracheostomy with traditional landmark technique
Active Comparator: ultrasound-guided long axis group
percutaneous tracheostomy will be implemented In the real-time ultrasound-guided in plane technique
to compare the reliability of the traditional landmark method, ultrasound-guided long axis in plane applications and ultrasound-guided short-axis out of plane application in the implementation process percutaneous tracheostomy
Active Comparator: ultrasound-guided short axis group
percutaneous tracheostomy will be implemented In the real-time ultrasound-guided out of plane technique
to compare the reliability of the traditional landmark method, ultrasound-guided long axis in plane applications and ultrasound-guided short-axis out of plane application in the implementation process percutaneous tracheostomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The success of the first application
Time Frame: ten minute
ten minute
successful tube placement rate
Time Frame: fifteen minüte
fifteen minüte
Complications during the procedure
Time Frame: one month
one month

Secondary Outcome Measures

Outcome Measure
Time Frame
The number of puncture
Time Frame: ten minute
ten minute
total tracheostomy application time
Time Frame: fifteen minute
fifteen minute
Early and late complications after the process
Time Frame: one month
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

July 31, 2016

First Submitted That Met QC Criteria

August 1, 2016

First Posted (Estimate)

August 4, 2016

Study Record Updates

Last Update Posted (Estimate)

January 31, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • ERZINCAN UNIVERSITY 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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