Tracheal StenosisNCT06121024
Long-term Outcomes of Post-intubation Tracheal Stenosis; 7-year Follow-up
An observational study of Tracheal Stenosis and Intensive Care Unit, run by Ankara Ataturk Sanatorium Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This retrospective, observational, cohort study evaluates the treatment management, long-term outcomes and survival analyses in patients hospitalized in the Intensive Care Unit with a diagnosis of Post-Intubation Tracheal Stenosis (PITS) between 1st June 2016 and 1st June 2022. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheal Stenosis, Intensive Care Unit
- What is being tested?
- Interventional Bronchoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Oct 2023to 15 Nov 2023
- 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: This retrospective study will analyze data from adult patients aged 18 years and above who were admitted with a diagnosis of PITS to the intensive care units of Health Sciences University Ankara Atatürk Sanatorium Training and Research Hospital and Yenimahalle Training and Research Hospital between 2016 and 2022. Patients who have a history of malignancy contributing to tracheal stenosis, patients who have a history of congenital tracheal anomalies or tracheal stenosis, those with incomplete intensive care follow-up information, patient follow-up files or hospital information system data, and patients who have been repeatedly hospitalized (with only the first hospitalisation data taken into account) shall be eliminated from the study.
Who may be able to join
- Age > 18,
- Intensive care patients diagnosed with post-intubation tracheal stenosis (PITS)
Who cannot join
- Patients with a history of malignancy in the etiology of tracheal stenosis
- Patients with a history of congenital tracheal anomaly or tracheal stenosis
- Patients with missing intensive care follow-up form, patient follow-up file or hospital information system data
- Repeated hospitalizations
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Atatürk Sanatorium Training and Research Hospital
Ankara, Keçiören, 06290
About this study
Official title: Long-term Outcomes of Intensive Care Unit Patients With Post-intubation Tracheal Stenosis; 7-year Follow-up
This retrospective, observational, cohort study evaluates the treatment management, long-term outcomes and survival analyses in patients hospitalized in the Intensive Care Unit with a diagnosis of Post-Intubation Tracheal Stenosis (PITS) between 1st June 2016 and 1st June 2022. The study emphasizes the role of bronchoscopic interventions in treatment management and the effective and efficient use of health services.
Read the detailed description
This retrospective study will analyze data from adult patients aged 18 years and above who were admitted with a diagnosis of Post-Intubation Tracheal Stenosis to the intensive care units of Health Sciences University Ankara Atatürk Sanatorium Training and Research Hospital and Yenimahalle Training and Research Hospital between 2016 and 2022. The analysis will examine data from both the hospital registration system and the patients' intensive care files. Patients who have a history of malignancy contributing to tracheal stenosis, patients who have a history of congenital tracheal anomalies or tracheal stenosis, those with incomplete intensive care follow-up information, patient follow-up files or hospital information system data, and patients who have been repeatedly hospitalized (with only the first hospitalisation data taken into account) shall be eliminated from the study. If patients who were discharged from the intensive care unit have one-year post-discharge data, the investigators will obtain the information from the hospital's follow-up system. Otherwise, investigators will collect information by calling patients or patients first-degree relatives by phone.The post-discharge data is from a past period, and the one-year follow-up period for the last patient included in the study ends on 1st June 2023.
The aim of the study is to determine whether early diagnosis and interventional bronchoscopic treatment have an impact on the length of intensive care unit stay and prognosis for patients with Post-Intubation Tracheal Stenosis whilst in the intensive care unit. This will be achieved through an investigation of patient outcomes following appropriate interventions.
- Conditions
- Tracheal Stenosis, Intensive Care Unit
- Being tested
- Interventional Bronchoscopy
- Keywords
- tracheal stenosis, post-intubation tracheal stenosis, intensive care unit, interventional bronchoscopy
- Medical subject headings
- Tracheal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventional BronchoscopyProcedure or surgery
Also called Rigid Bronchoscopy
Bronchoscopy offers vital information when evaluating patients suffering from tracheal stenosis. It enables direct visualisation which identifies the lesion, determines its location and extent of airway involvement, highlights vascularity and fragility, allows for tissue diagnosis and enables the operator to assess the extent of mucosal infiltration and airway compression caused by the tumour. The technique facilitates assessment of stenosis diameter for suitable stent selection. In addition to enabling diagnostic bronchoscopy, rigid bronchoscopy offers therapeutic options such as dilatation, cryotherapy and stenting for tracheal stenosis patients. Our clinical setting employs rigid bronchoscopy for interventional procedures with both diagnostic and therapeutic aspects.
| Study group | Role | What they receive |
|---|---|---|
| Simple Tracheal Stenosis | Simple stenosis was defined as lesions with a vertical extension <1 cm (short segment) with endoluminal occlusion, without tracheomalacia or loss of cartilage support. Receives: Procedure: Interventional Bronchoscopy | |
| Complex Tracheal Stenosis | Complex stenosis were defined as lesions ≥1 cm and varying degrees of cartilage involvement or circumferential contractile scar or tracheal stenosis associated with malacia and inflammation. Receives: Procedure: Interventional Bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
One-year mortality data following interventional bronchoscopic treatment for post-intubation tracheal stenosis in patients hospitalized in the intensive care unit
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start12 Oct 2023
- Primary completion12 Nov 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheal StenosisStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research Hospital
- Sponsor type
- Other government
- Collaborators
- Yenimahalle Education and Research Hospital
- Responsible party
- Principal investigator, Onur Kucuk, Ankara Ataturk Sanatorium Training and Research Hospital
- Investigators
- Onur KÜÇÜK, specialist, Principal investigator, Ankara Ataturk Sanatorium Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06121024
- Sponsor's protocol ID
- E-2023-52
- Status last verified
- Nov 2023
- First submitted
- 2 Nov 2023
- Last updated
- 1 Dec 2023
- 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 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes of Intensive Care Unit Patients With Post-intubation Tracheal Stenosis; 7-year Follow-up
- ClinicalTrials.gov ID
- NCT06121024
- Acronym / sponsor ID
- E-2023-52
- Conditions
- Tracheal Stenosis, Intensive Care Unit
- Keywords
- tracheal stenosis, post-intubation tracheal stenosis, intensive care unit, interventional bronchoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research HospitalOther government
- Collaborators
- Yenimahalle Education and Research Hospital
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- 12 Nov 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 7 Nov 2023 (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 retrospective, observational, cohort study evaluates the treatment management, long-term outcomes and survival analyses in patients hospitalized in the Intensive Care Unit with a diagnosis of Post-Intubation Tracheal Stenosis (PITS) between 1st June 2016 and 1st June 2022. The study emphasizes the role of bronchoscopic interventions in treatment management and the effective and efficient use of health services.
Detailed description
This retrospective study will analyze data from adult patients aged 18 years and above who were admitted with a diagnosis of Post-Intubation Tracheal Stenosis to the intensive care units of Health Sciences University Ankara Atatürk Sanatorium Training and Research Hospital and Yenimahalle Training and Research Hospital between 2016 and 2022. The analysis will examine data from both the hospital registration system and the patients' intensive care files. Patients who have a history of malignancy contributing to tracheal stenosis, patients who have a history of congenital tracheal anomalies or tracheal stenosis, those with incomplete intensive care follow-up information, patient follow-up files or hospital information system data, and patients who have been repeatedly hospitalized (with only the first hospitalisation data taken into account) shall be eliminated from the study. If patients who were discharged from the intensive care unit have one-year post-discharge data, the investigators will obtain the information from the hospital's follow-up system. Otherwise, investigators will collect information by calling patients or patients first-degree relatives by phone.The post-discharge data is from a past period, and the one-year follow-up period for the last patient included in the study ends on 1st June 2023.
The aim of the study is to determine whether early diagnosis and interventional bronchoscopic treatment have an impact on the length of intensive care unit stay and prognosis for patients with Post-Intubation Tracheal Stenosis whilst in the intensive care unit. This will be achieved through an investigation of patient outcomes following appropriate interventions.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simple Tracheal Stenosis | – | Procedure: Interventional BronchoscopySimple stenosis was defined as lesions with a vertical extension <1 cm (short segment) with endoluminal occlusion, without tracheomalacia or loss of cartilage support. |
| Complex Tracheal Stenosis | – | Procedure: Interventional BronchoscopyComplex stenosis were defined as lesions ≥1 cm and varying degrees of cartilage involvement or circumferential contractile scar or tracheal stenosis associated with malacia and inflammation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective study will analyze data from adult patients aged 18 years and above who were admitted with a diagnosis of PITS to the intensive care units of Health Sciences University Ankara Atatürk Sanatorium Training and Research Hospital and Yenimahalle Training and Research Hospital between 2016 and 2022. Patients who have a history of malignancy contributing to tracheal stenosis, patients who have a history of congenital tracheal anomalies or tracheal stenosis, those with incomplete intensive care follow-up information, patient follow-up files or hospital information system data, and patients who have been repeatedly hospitalized (with only the first hospitalisation data taken into account) shall be eliminated from the study.
Key inclusion criteria (2 listed)
- Age > 18,
- Intensive care patients diagnosed with post-intubation tracheal stenosis (PITS)
Key exclusion criteria (4 listed)
- Patients with a history of malignancy in the etiology of tracheal stenosis
- Patients with a history of congenital tracheal anomaly or tracheal stenosis
- Patients with missing intensive care follow-up form, patient follow-up file or hospital information system data
- Repeated hospitalizations
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 |
|---|---|---|
| Interventional BronchoscopyAlso: Rigid BronchoscopyBronchoscopy offers vital information when evaluating patients suffering from tracheal stenosis. It enables direct visualisation which identifies the lesion, determines its location and extent of airway involvement, highlights vascularity and fragility, allows for tissue diagnosis and enables the operator to assess the extent of mucosal infiltration and airway compression caused by the tumour. The technique facilitates assessment of stenosis diameter for suitable stent selection. In addition to enabling diagnostic bronchoscopy, rigid bronchoscopy offers therapeutic options such as dilatation, cryotherapy and stenting for tracheal stenosis patients. Our clinical setting employs rigid bronchoscopy for interventional procedures with both diagnostic and therapeutic aspects. | Procedure or surgery | Complex Tracheal Stenosis, Simple Tracheal Stenosis |
Primary outcome
Mortality
Time frame: 1 year
One-year mortality data following interventional bronchoscopic treatment for post-intubation tracheal stenosis in patients hospitalized in the intensive care unit
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 1 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Onur KÜÇÜK, specialist principal investigator
Ankara Ataturk Sanatorium Training and Research Hospital
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 Tracheal Stenosis and Intensive Care Unit, run by Ankara Ataturk Sanatorium Training and Research Hospital 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 2 inclusion and 4 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 1 Dec 2023. 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?
Mortality (time frame: 1 year). 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 1 Dec 2023.