Airway Management During Unusual Tracheal Stenosis

Tracheal Stenosis Clinical Trial

Official title:

Airway Management During Unusual Tracheal Stenosis: A Clinical Feasibility Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05317923
• Other study ID #: 2021/1958
• Status: Completed
• Phase: N/A
• Start date: March 14, 2022
• Est. completion date: September 1, 2022

Study information

• Verified date: September 2022
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 1, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Tracheal Stenosis

Intervention

Other:
• Flow Controlled Ventilation
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

Locations

Country	Name	City	State
Turkey	Istanbul University, Department of Anesthesiology	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	length of intubation due to Covid-19 Pnomonia	time from intubation to extubation in ICU	postoperative period (up to 1 year)
Secondary	sPO2	peripheral oxygen saturation	SPO2 value at baseline, peroperative 5, 15, 30, 45 minutes after induction, and before the extubation through surgery completion
Secondary	Myers-Cotton grading scale (1/2/3)	The grade of tracheal stenosis	before the surgery
Secondary	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