Tracheostomy ComplicationNCT05514613
Effectiveness of Reel-time Ultrasound-guided Tracheostomy and Landmark Percutaneous Dilatational Tracheostomy
An observational study of Tracheostomy Complication, run by HULYA TOPCU at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheostomy Complication
- What is being tested?
- retrospektif study; The effect of tracheostomy tecnique method on complications
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 22 Dec 2021
- Phase
- Observational
- 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
Study population: Patients over the age of 18 who were hospitalized in the intensive care unit and underwent tracheostomy
Who may be able to join
- Hospitalized in the intensive care unit and tracheostomy was opened and over 18 years.
Who cannot join
- surgical opened tracheostomy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Çorum training and research state hospital
Çorum, 19030
About this study
Official title: Comparative Effectiveness of Reel-time Ultrasound-guided Tracheostomy and Anatomic Landmark Percutaneous Dilatational Tracheostomy: a Retrospective Cohort Study
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.
Read the detailed description
This study, patients who were admitted to the intensive care unit of hospital and who had a tracheostomy were examined. This is a retrospective study conducted to evaluate the method used during tracheostomy and themcomplications that occurred during and after tracheostomy opening.
2852 intensive care patients hospitalized in hospital intensive care unit after obtaining ethical permission were investigated retrospectively by scanning their files and digital data, and their complications during and after tracheostomy procedures.
- Conditions
- Tracheostomy Complication
- Being tested
- retrospektif study; The effect of tracheostomy tecnique method on complications
- Keywords
- ultrasound guided tracheostomy, anatomic landmark tracheostomy, tracheostomy, complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Group G | Group G is a tracheostomy group opened using the anatomical sign technique (Griggs technique). Receives: Other: retrospektif study; The effect of tracheostomy tecnique method on complications | |
| Group U | Group U; Ultrasound-guided is used during tracheostomy technique. Receives: Other: retrospektif study; The effect of tracheostomy tecnique method on complications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound-guided Tracheostomy and Landmark Percutaneous Dilatational Tracheostomy
the relationship of complications with the tracheostomy technique
Measured: 01.04.2017-11.03.2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start1 Jan 2019
- Primary completion10 Nov 2019
- Study completion22 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheostomy ComplicationStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- HULYA TOPCU
- Sponsor type
- University, hospital or other
- Collaborators
- Serhat Ozciftci
- Responsible party
- Sponsor-investigator, HULYA TOPCU, Erol Olcok Corum Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05514613
- Sponsor's protocol ID
- CorumTRH
- Status last verified
- Aug 2022
- First submitted
- 9 Aug 2022
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Reel-time Ultrasound-guided Tracheostomy and Anatomic Landmark Percutaneous Dilatational Tracheostomy: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05514613
- Acronym / sponsor ID
- CorumTRH
- Conditions
- Tracheostomy Complication
- Keywords
- ultrasound guided tracheostomy, anatomic landmark tracheostomy, tracheostomy, complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- HULYA TOPCUUniversity, hospital or other
- Collaborators
- Serhat Ozciftci
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 10 Nov 2019 (actual)
- Study completion
- 22 Dec 2021 (actual)
- First posted
- 24 Aug 2022 (actual)
- 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.
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.
Detailed description
This study, patients who were admitted to the intensive care unit of hospital and who had a tracheostomy were examined. This is a retrospective study conducted to evaluate the method used during tracheostomy and themcomplications that occurred during and after tracheostomy opening.
2852 intensive care patients hospitalized in hospital intensive care unit after obtaining ethical permission were investigated retrospectively by scanning their files and digital data, and their complications during and after tracheostomy procedures.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group G | – | Other: retrospektif study; The effect of tracheostomy tecnique method on complicationsGroup G is a tracheostomy group opened using the anatomical sign technique (Griggs technique). |
| Group U | – | Other: retrospektif study; The effect of tracheostomy tecnique method on complicationsGroup U; Ultrasound-guided is used during tracheostomy technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over the age of 18 who were hospitalized in the intensive care unit and underwent tracheostomy
Key inclusion criteria (1 listed)
- Hospitalized in the intensive care unit and tracheostomy was opened and over 18 years.
Key exclusion criteria (1 listed)
- surgical opened tracheostomy
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 |
|---|---|---|
| retrospektif study; The effect of tracheostomy tecnique method on complicationsretrospektif study; The effect of tracheostomy tecnique method on complications complications and correlation of complications with techniques | Other | Group G, Group U |
Primary outcome
Ultrasound-guided Tracheostomy and Landmark Percutaneous Dilatational Tracheostomy
Time frame: 01.04.2017-11.03.2019
the relationship of complications with the tracheostomy technique
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 24 Aug 2022.
- Individual participant dataSharing planned: No
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Complications Related to the Anaesthesia During Airway Endoscopy in Children With Tracheostomy.
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"Airway Complications in Pediatric Patients With Tracheostomies: To What Extent Can Symptoms Identified by Caregivers or Pediatricians Serve as Predictors for Airway Complications Confirmed Through Surveillance Endoscopy?"
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tracheostomy Complication, run by HULYA TOPCU at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Ultrasound-guided Tracheostomy and Landmark Percutaneous Dilatational Tracheostomy (time frame: 01.04.2017-11.03.2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2022.