Tracheal StenosisNCT05317923
Airway Management During Unusual Tracheal Stenosis
A study of Tracheal Stenosis, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Tracheal stenosis is a serious complication following prolonged intubation. There are important differences in the challenges of airway management. This study consists of our anesthesia management experience in patients with unusual placement of tracheal stenosis due to Covid-19 undergoing tracheal dilatation. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Tracheal Stenosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Mar 2022to 1 Sep 2022
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA 1-2-3 patients over the age of 18 who are scheduled for an elective laryngeal procedure due to subglottic stenosis will be included in our study.
Who cannot join
- Patients who did not agree to participate in the study.
- Congestive heart failure (ejection fraction ≤ 35 %)
- Emergency laryngeal procedures.
- Patients under 18 years old.
- Patients with ASA > 3.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Department of Anesthesiology
Istanbul, 34093
About this study
Official title: Airway Management During Unusual Tracheal Stenosis: A Clinical Feasibility Trial
Tracheal stenosis is a serious complication following prolonged intubation. There are important differences in the challenges of airway management. This study consists of our anesthesia management experience in patients with unusual placement of tracheal stenosis due to Covid-19 undergoing tracheal dilatation.
Read the detailed description
Tracheal stenosis is a serious complication following prolonged intubation. Two types of tracheal stenosis; Glottic and subglottic stenoses have common features in that they are challenging in terms of ventilation, oxygenation and intubation. However, there are important differences in the challenges of airway managementA thinner tube may be sufficient to overcome the airway difficulty in glottic stenoses. However, in subglottic tracheal stenosis, a thinner tube may not be conveyed to the distal of the stenosis. As a result, adequate ventilation and oxygenation may not be provided with an intubation tube placed proximal to the trachea. This study consists of our anesthesia management experience in patients with unusual placement of tracheal stenosis due to Covid-19 undergoing tracheal dilatation.
- Conditions
- Tracheal Stenosis
- Being tested
- Flow Controlled Ventilation
- Keywords
- prolonged intubation,, tracheal stenosis, Covid-19
- 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.
Flow Controlled VentilationOther
Anesthesia management in patients with subglottic tracheal stenosis with flow-controlled ventilation using an intubation tube with an inner diameter of less than 3 mm
| Study group | Role | What they receive |
|---|---|---|
| airway management and ventilation in patients with unusual placement of tracheal stenosis | Experimental | Flow-controlled ventilation (FCV) in patients with unusual placement of tracheal stenosis Receives: Other: Flow Controlled Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCO2
blood partial pressure of carbondioxide
Measured: PCO2 value at baseline just before entubation, peroperative 5, 15, 30, 45 minutes after induction, and before the extubation through surgery completion
PO2
blood partial pressure of oxygen
Measured: PO2 value at baseline just before entubation, peroperative 5, 15, 30, 45 minutes after induction, and before the extubation through surgery completion
Secondary outcomes (5)
EtCO2
end-tidal carbondioxide measurement
Measured: EtCO2 value at baseline just before entubation, peroperative 5, 15, 30, 45 minutes after induction, and before the extubation through surgery completion
length of intubation due to Covid-19 Pnomonia
time from intubation to extubation in ICU
Measured: postoperative period (up to 1 year)
sPO2
peripheral oxygen saturation
Measured: SPO2 value at baseline, peroperative 5, 15, 30, 45 minutes after induction, and before the extubation through surgery completion
Myers-Cotton grading scale (1/2/3)
The grade of tracheal stenosis
Measured: before the surgery
VAS (Visual Analogue Scale) score (between 0 to 10 points)
surgeons' satisfaction(VAS 0=the worst view, 10= the best view)
Measured: during surgery through surgery completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start14 Mar 2022
- Primary completion30 Jun 2022
- Study completion1 Sep 2022
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 Istanbul UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demet Altun, Istanbul University
- Investigators
- Istnabul University, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317923
- Sponsor's protocol ID
- 2021/1958
- Status last verified
- Sep 2022
- First submitted
- 14 Mar 2022
- Last updated
- 16 Sep 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 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Management During Unusual Tracheal Stenosis: A Clinical Feasibility Trial
- ClinicalTrials.gov ID
- NCT05317923
- Acronym / sponsor ID
- 2021/1958
- Conditions
- Tracheal Stenosis
- Keywords
- prolonged intubation,, tracheal stenosis, Covid-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 8 Apr 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.
Tracheal stenosis is a serious complication following prolonged intubation. There are important differences in the challenges of airway management. This study consists of our anesthesia management experience in patients with unusual placement of tracheal stenosis due to Covid-19 undergoing tracheal dilatation.
Detailed description
Tracheal stenosis is a serious complication following prolonged intubation. Two types of tracheal stenosis; Glottic and subglottic stenoses have common features in that they are challenging in terms of ventilation, oxygenation and intubation. However, there are important differences in the challenges of airway managementA thinner tube may be sufficient to overcome the airway difficulty in glottic stenoses. However, in subglottic tracheal stenosis, a thinner tube may not be conveyed to the distal of the stenosis. As a result, adequate ventilation and oxygenation may not be provided with an intubation tube placed proximal to the trachea. This study consists of our anesthesia management experience in patients with unusual placement of tracheal stenosis due to Covid-19 undergoing tracheal dilatation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| airway management and ventilation in patients with unusual placement of tracheal stenosis | Experimental | Other: Flow Controlled VentilationFlow-controlled ventilation (FCV) in patients with unusual placement of tracheal stenosis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA 1-2-3 patients over the age of 18 who are scheduled for an elective laryngeal procedure due to subglottic stenosis will be included in our study.
Key exclusion criteria (5 listed)
- Patients who did not agree to participate in the study.
- Congestive heart failure (ejection fraction ≤ 35 %)
- Emergency laryngeal procedures.
- Patients under 18 years old.
- Patients with ASA > 3.
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 |
|---|---|---|
| Flow Controlled VentilationAnesthesia management in patients with subglottic tracheal stenosis with flow-controlled ventilation using an intubation tube with an inner diameter of less than 3 mm | Other | airway management and ventilation in patients with unusual placement of tracheal stenosis |
Primary outcome
PCO2
Time frame: PCO2 value at baseline just before entubation, peroperative 5, 15, 30, 45 minutes after induction, and before the extubation through surgery completion
blood partial pressure of carbondioxide
PO2
Time frame: PO2 value at baseline just before entubation, peroperative 5, 15, 30, 45 minutes after induction, and before the extubation through surgery completion
blood partial pressure of oxygen
5 secondary outcomes
EtCO2
Time frame: EtCO2 value at baseline just before entubation, peroperative 5, 15, 30, 45 minutes after induction, and before the extubation through surgery completion
length of intubation due to Covid-19 Pnomonia
Time frame: postoperative period (up to 1 year)
sPO2
Time frame: SPO2 value at baseline, peroperative 5, 15, 30, 45 minutes after induction, and before the extubation through surgery completion
Myers-Cotton grading scale (1/2/3)
Time frame: before the surgery
VAS (Visual Analogue Scale) score (between 0 to 10 points)
Time frame: during surgery through surgery completion
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 16 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Tracheal Stenosis
Not yet recruitingPhase 1
Pirfenidone for Idiopathic Subglottic Stenosis: A Pilot Trial of Tolerability and Feasibility
Idiopathic Subglottic Stenosis, Subglottic Stenosis (SGS)
Not yet recruitingObservational study
Laryngotracheal Lesions in Adults With Long-Term Tracheostomy
Laryngotracheal Lesions, Tracheostomy Complications
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 3
Adjuvant Steroid Outcomes in Idiopathic Subglottic Stenosis
Idiopathic Subglottic Stenosis
Recruiting
Transcriptomic Profile Changes in Benign Tracheal Stenosis: Wedge Resection vs. Radial Incision
Tracheal Stenosis
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.
Istnabul University principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Tracheal Stenosis, run by Istanbul University 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 5 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 16 Sep 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?
PCO2 (time frame: PCO2 value at baseline just before entubation, peroperative 5, 15, 30, 45 minutes after induction, and before the extubation through surgery completion). The study lists 2 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 16 Sep 2022.