Tracheal StenosisNCT05682651
Relationship Between Post-Intubation Tracheal Stenosis and Covid-19
An observational study of Tracheal Stenosis and COVID-19, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Tracheal stenosis (TS) is a serious complication that occurs in approximately 6-22% of patients due to prolonged endotracheal intubation. Cuff hyperinflation of the endotracheal tube, use of large tubes, advanced age, female gender, smoking, obesity, and diabetes are risk factors for TS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheal Stenosis, COVID-19, Post-Intubation Subglottic Stenosis
- What is being tested?
- tracheal stenosis follow-up file
- Type of treatment
- Surgery or procedure
- How many people
- 101 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Dec 2022to 28 May 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
- Adult, Older adult
Study population: Patients older than 18 years of age and without a history of malignancy who developed post-intubation tracheal stenosis are included in the study.
Who may be able to join
- Patients older than 18 years
Who cannot join
- Patients undergoing surgical procedures for malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Etiological Investigation of 'Post-Intubation Tracheal Stenosis' Cases Requiring Intervention: 2-year Case Review
Tracheal stenosis (TS) is a serious complication that occurs in approximately 6-22% of patients due to prolonged endotracheal intubation. Cuff hyperinflation of the endotracheal tube, use of large tubes, advanced age, female gender, smoking, obesity, and diabetes are risk factors for TS. The most common and serious complication in COVID-19 patients is acute respiratory distress syndrome (ARDS), which requires oxygen and ventilation treatments. In the literature, it is reported that 9.8-15.2% of patients need invasive mechanical ventilation (IMV). The concern of aerosol formation and prone position applications that emerged with the coronavirus pandemic caused delays in tracheostomy decisions and the use of uncontrolled high cuff pressures, paving the way for TS. The capillary perfusion pressure of the tracheal mucosa ranges from 20 to 30 mmHg. A cuff pressure of the endotracheal tube above 30 mmHg causes mucosal ischemia. Cartilage inflammation due to ischemic injury may be partial or full thickness. Depending on the degree of inflammation in the affected tracheal segments, stenosis and even perforation may develop.
It is aimed to determine the etiological causes, to determine how much of the total TS cases covid-related TS constitutes, to examine the treatments and patient results in covid/non-covid TS.
This study will contribute to the measures that can be taken during and after the care process in the intensive care unit.
- Being tested
- tracheal stenosis follow-up file
- Medical subject headings
- Tracheal Stenosis, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tracheal stenosis follow-up fileProcedure or surgery
Patients' age, gender, American Society of Anesthesiologists (ASA) classification, comorbidities, etiologic cause, intubation time, type of surgery, length of hospital stay, and morbidity/mortality information will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Tracheal Stenosis with Covid-19 | Patients' age, gender, American Society of Anesthesiologists (ASA) classification, comorbidities, etiologic cause, intubation time, type of surgery, length of hospital stay, and morbidity/mortality information will be recorded. Receives: Procedure: tracheal stenosis follow-up file | |
| Tracheal Stenosis with Non-Covid-19 | Patients' age, gender, American Society of Anesthesiologists (ASA) classification, comorbidities, etiologic cause, intubation time, type of surgery, length of hospital stay, and morbidity/mortality information will be recorded. Receives: Procedure: tracheal stenosis follow-up file |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation time
Duration of intubation of patients (in days)
Measured: Up to 3 months
Morbidity/mortality
Morbidity/mortality status of the patients within 3 months
Measured: Up to 2 months
Length of hospital stay
The hospital stay of the patients will be recorded (in days)
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start28 Dec 2022
- Primary completion28 Apr 2023
- Study completion28 May 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.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilgün Zengin, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682651
- Sponsor's protocol ID
- E.Kurul-E1-22-3142
- Status last verified
- Feb 2024
- First submitted
- 7 Jan 2023
- Last updated
- 2 Feb 2024
- 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 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etiological Investigation of 'Post-Intubation Tracheal Stenosis' Cases Requiring Intervention: 2-year Case Review
- ClinicalTrials.gov ID
- NCT05682651
- Acronym / sponsor ID
- E.Kurul-E1-22-3142
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 28 Dec 2022 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 28 May 2023 (actual)
- First posted
- 12 Jan 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.
Tracheal stenosis (TS) is a serious complication that occurs in approximately 6-22% of patients due to prolonged endotracheal intubation. Cuff hyperinflation of the endotracheal tube, use of large tubes, advanced age, female gender, smoking, obesity, and diabetes are risk factors for TS. The most common and serious complication in COVID-19 patients is acute respiratory distress syndrome (ARDS), which requires oxygen and ventilation treatments. In the literature, it is reported that 9.8-15.2% of patients need invasive mechanical ventilation (IMV). The concern of aerosol formation and prone position applications that emerged with the coronavirus pandemic caused delays in tracheostomy decisions and the use of uncontrolled high cuff pressures, paving the way for TS. The capillary perfusion pressure of the tracheal mucosa ranges from 20 to 30 mmHg. A cuff pressure of the endotracheal tube above 30 mmHg causes mucosal ischemia. Cartilage inflammation due to ischemic injury may be partial or full thickness. Depending on the degree of inflammation in the affected tracheal segments, stenosis and even perforation may develop.
It is aimed to determine the etiological causes, to determine how much of the total TS cases covid-related TS constitutes, to examine the treatments and patient results in covid/non-covid TS.
This study will contribute to the measures that can be taken during and after the care process in the intensive care unit.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tracheal Stenosis with Covid-19 | – | Procedure: tracheal stenosis follow-up filePatients' age, gender, American Society of Anesthesiologists (ASA) classification, comorbidities, etiologic cause, intubation time, type of surgery, length of hospital stay, and morbidity/mortality information will be recorded. |
| Tracheal Stenosis with Non-Covid-19 | – | Procedure: tracheal stenosis follow-up filePatients' age, gender, American Society of Anesthesiologists (ASA) classification, comorbidities, etiologic cause, intubation time, type of surgery, length of hospital stay, and morbidity/mortality information will be recorded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients older than 18 years of age and without a history of malignancy who developed post-intubation tracheal stenosis are included in the study.
Key inclusion criteria (1 listed)
- Patients older than 18 years
Key exclusion criteria (1 listed)
- Patients undergoing surgical procedures for malignancy
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 |
|---|---|---|
| tracheal stenosis follow-up filePatients' age, gender, American Society of Anesthesiologists (ASA) classification, comorbidities, etiologic cause, intubation time, type of surgery, length of hospital stay, and morbidity/mortality information will be recorded. | Procedure or surgery | Tracheal Stenosis with Covid-19, Tracheal Stenosis with Non-Covid-19 |
Primary outcome
Intubation time
Time frame: Up to 3 months
Duration of intubation of patients (in days)
Morbidity/mortality
Time frame: Up to 2 months
Morbidity/mortality status of the patients within 3 months
Length of hospital stay
Time frame: Up to 3 months
The hospital stay of the patients will be recorded (in days)
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 2 Feb 2024.
- 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.
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 Tracheal Stenosis and COVID-19, run by Ankara City Hospital Bilkent 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 2 Feb 2024. 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?
Intubation time (time frame: Up to 3 months). 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?
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 2 Feb 2024; AzTrials last refreshed its copy on 6 Nov 2026.