Clinical trial NCT02855749: Ultrasound Guided Percutaneous Tracheostomy
Official title: Comparison of 3 Techniques for Percutaneous Tracheostomy : Traditional Marking Technique, Ultrasonography Guided Long Axis Approach and Short Axis Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reliability of the Ultrasound in Percutaneous Tracheostomy
Lead sponsor: Erzincan University
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: The success of the first application
timeFrame: ten minute
measure: successful tube placement rate
timeFrame: fifteen minüte
measure: Complications during the procedure
timeFrame: one month
Secondary outcomes:
measure: The number of puncture
timeFrame: ten minute
measure: total tracheostomy application time
timeFrame: fifteen minute
measure: Early and late complications after the process
timeFrame: one month
Other outcomes:
Locations:
Study officials:
affiliation: Erzincan University
name: İlke kupeli
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.