Clinical trial NCT05317923: Airway Management During Unusual Tracheal Stenosis
Official title: Airway Management During Unusual Tracheal Stenosis: A Clinical Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tracheal Stenosis
Keywords: prolonged intubation,
tracheal stenosis
Covid-19
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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:

1. Patients who did not agree to participate in the study.
2. Congestive heart failure (ejection fraction ≤ 35 %)
3. Emergency laryngeal procedures.
4. Patients under 18 years old.
5. Patients with ASA \> 3.

Primary outcomes:
measure: PCO2
timeFrame: PCO2 value at baseline just before entubation, peroperative 5, 15, 30, 45 minutes after induction, and before the extubation through surgery completion
measure: PO2
timeFrame: PO2 value at baseline just before entubation, peroperative 5, 15, 30, 45 minutes after induction, and before the extubation through surgery completion
Secondary outcomes:
measure: EtCO2
timeFrame: EtCO2 value at baseline just before entubation, peroperative 5, 15, 30, 45 minutes after induction, and before the extubation through surgery completion
measure: length of intubation due to Covid-19 Pnomonia
timeFrame: postoperative period (up to 1 year)
measure: sPO2
timeFrame: SPO2 value at baseline, peroperative 5, 15, 30, 45 minutes after induction, and before the extubation through surgery completion
measure: Myers-Cotton grading scale (1/2/3)
timeFrame: before the surgery
measure: VAS (Visual Analogue Scale) score (between 0 to 10 points)
timeFrame: during surgery through surgery completion
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University, Department of Anesthesiology
Study officials:
affiliation: Istanbul University
name: Istnabul University
role: PRINCIPAL_INVESTIGATOR
References: