Reliability of the Ultrasound in Percutaneous TracheostomyNCT02855749
Ultrasound Guided Percutaneous Tracheostomy
A study testing ultrasound-guided percutaneous tracheostomy in people with Reliability of the Ultrasound in Percutaneous Tracheostomy, run by Erzincan University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reliability of the Ultrasound in Percutaneous Tracheostomy
- What is being tested?
- ultrasound-guided percutaneous tracheostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hospitalized patients in intensive care
- the decision to open percutaneous tracheostomy
- over 18 years
Who cannot join
- 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
About this study
Official title: 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.
- Being tested
- ultrasound-guided percutaneous tracheostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-guided percutaneous tracheostomyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| landmark group | No intervention | percutaneous tracheostomy with traditional landmark technique |
| ultrasound-guided long axis group | Active comparator | percutaneous tracheostomy will be implemented In the real-time ultrasound-guided in plane technique Receives: Procedure: ultrasound-guided percutaneous tracheostomy |
| ultrasound-guided short axis group | Active comparator | percutaneous tracheostomy will be implemented In the real-time ultrasound-guided out of plane technique Receives: Procedure: ultrasound-guided percutaneous tracheostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success of the first application
Measured: ten minute
successful tube placement rate
Measured: fifteen minüte
Complications during the procedure
Measured: one month
Secondary outcomes (3)
The number of puncture
Measured: ten minute
total tracheostomy application time
Measured: fifteen minute
Early and late complications after the process
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionNov 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Reliability of the Ultrasound in Percutaneous TracheostomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erzincan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ILKE KUPELI, Erzincan University
- Investigators
- İlke kupeli, Principal investigator, Erzincan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02855749
- Sponsor's protocol ID
- ERZINCAN UNIVERSITY 2
- Status last verified
- Jan 2017
- First submitted
- 31 Jul 2016
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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.
PubMed 16606435Cheung 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.
PubMed 24891198Simon 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.
PubMed 24168826McCormick 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.
PubMed 15819770Flint 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.
PubMed 19680824Rudas 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.
PubMed 28191160Chacko 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.
PubMed 22349428Rajajee 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.
PubMed 21342494Kupeli 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.
PubMed 29225012
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 3 Techniques for Percutaneous Tracheostomy : Traditional Marking Technique, Ultrasonography Guided Long Axis Approach and Short Axis Approach
- ClinicalTrials.gov ID
- NCT02855749
- Acronym / sponsor ID
- ERZINCAN UNIVERSITY 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Erzincan UniversityUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 4 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| landmark group | No intervention | –percutaneous tracheostomy with traditional landmark technique |
| ultrasound-guided long axis group | Active comparator | Procedure: ultrasound-guided percutaneous tracheostomypercutaneous tracheostomy will be implemented In the real-time ultrasound-guided in plane technique |
| ultrasound-guided short axis group | Active comparator | Procedure: ultrasound-guided percutaneous tracheostomypercutaneous tracheostomy will be implemented In the real-time ultrasound-guided out of plane technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- hospitalized patients in intensive care
- the decision to open percutaneous tracheostomy
- over 18 years
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound-guided percutaneous tracheostomyto 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 | Procedure or surgery | ultrasound-guided long axis group, ultrasound-guided short axis group |
Primary outcome
The success of the first application
Time frame: ten minute
successful tube placement rate
Time frame: fifteen minüte
Complications during the procedure
Time frame: one month
3 secondary outcomes
The number of puncture
Time frame: ten minute
total tracheostomy application time
Time frame: fifteen minute
Early and late complications after the process
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
- Results publication: PubMed 16606435Delaney 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.
- Results publication: PubMed 24891198Cheung 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.
- Results publication: PubMed 24168826Simon 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.
- Results publication: PubMed 15819770McCormick 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.
- Results publication: PubMed 19680824Flint 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.
- Results publication: PubMed 28191160Rudas 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.
- Results publication: PubMed 22349428Chacko 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.
- Results publication: PubMed 21342494Rajajee 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.
- Derived from this study: PubMed 29225012Kupeli 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İlke kupeli principal investigator
Erzincan University
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound-guided percutaneous tracheostomy in people with Reliability of the Ultrasound in Percutaneous Tracheostomy, run by Erzincan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The success of the first application (time frame: ten minute). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02855749, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2017.