Airway Management During Unusual Tracheal Stenosis

Study Overview
=================
Brief 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.

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.

Official Title
-----------------
Airway Management During Unusual Tracheal Stenosis: A Clinical Feasibility Trial

Conditions
-----------------
Tracheal Stenosis

Intervention / Treatment
-----------------
* Other: Flow Controlled Ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: airway management and ventilation in patients with unusual placement of tracheal stenosis<br>Flow-controlled ventilation (FCV) in patients with unusual placement of tracheal stenosis | Other: Flow Controlled Ventilation<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCO2 | blood partial pressure of carbondioxide | 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 | PO2 value at baseline just before entubation, peroperative 5, 15, 30, 45 minutes after induction, and before the extubation through surgery completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EtCO2 | end-tidal carbondioxide measurement | 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 | postoperative period (up to 1 year) | 
| sPO2 | peripheral oxygen saturation | 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 | before the surgery | 
| VAS (Visual Analogue Scale) score (between 0 to 10 points) | surgeons' satisfaction(VAS 0=the worst view, 10= the best view) | during surgery through surgery completion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prolonged intubation,, tracheal stenosis, Covid-19