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
Status
Completed
Intervention / Treatment
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.
Sponsor
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
- Delaney A, Bagshaw SM, Nalos M. Percutaneous dilatational tracheostomy versus surgical tracheostomy in critically ill patients: a systematic review and meta-analysis. Crit Care. 2006;10(2):R55. doi: 10.1186/cc4887.
- Cheung NH, Napolitano LM. Tracheostomy: epidemiology, indications, timing, technique, and outcomes. Respir Care. 2014 Jun;59(6):895-915; discussion 916-9. doi: 10.4187/respcare.02971.
- Simon M, Metschke M, Braune SA, Puschel K, Kluge S. Death after percutaneous dilatational tracheostomy: a systematic review and analysis of risk factors. Crit Care. 2013 Oct 29;17(5):R258. doi: 10.1186/cc13085.
- McCormick B, Manara AR. Mortality from percutaneous dilatational tracheostomy. A report of three cases. Anaesthesia. 2005 May;60(5):490-5. doi: 10.1111/j.1365-2044.2005.04137.x.
- Flint AC, Midde R, Rao VA, Lasman TE, Ho PT. Bedside ultrasound screening for pretracheal vascular structures may minimize the risks of percutaneous dilatational tracheostomy. Neurocrit Care. 2009 Dec;11(3):372-6. doi: 10.1007/s12028-009-9259-z. Epub 2009 Aug 13.
- Rudas M. The role of ultrasound in percutaneous dilatational tracheostomy. Australas J Ultrasound Med. 2012 Nov;15(4):143-148. doi: 10.1002/j.2205-0140.2012.tb00197.x. Epub 2015 Dec 31.
- Chacko J, Nikahat J, Gagan B, Umesh K, Ramanathan M. Real-time ultrasound-guided percutaneous dilatational tracheostomy. Intensive Care Med. 2012 May;38(5):920-1. doi: 10.1007/s00134-012-2514-3. Epub 2012 Feb 17. No abstract available.
- Rajajee V, Fletcher JJ, Rochlen LR, Jacobs TL. Real-time ultrasound-guided percutaneous dilatational tracheostomy: a feasibility study. Crit Care. 2011;15(1):R67. doi: 10.1186/cc10047. Epub 2011 Feb 22.
- Kupeli I, Nalbant RA. Comparison of 3 techniques in percutaneous tracheostomy: Traditional landmark technique; ultrasonography-guided long-axis approach; and short-axis approach - Randomised controlled study. Anaesth Crit Care Pain Med. 2018 Dec;37(6):533-538. doi: 10.1016/j.accpm.2017.11.011. Epub 2017 Dec 7.
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
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