Airway Management During Unusual Tracheal Stenosis

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.

Study Overview

• Status: Completed
• Conditions: Tracheal Stenosis
• Intervention / Treatment: Other: Flow Controlled Ventilation

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34093
    • Istanbul University, Department of Anesthesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: airway management and ventilation in patients with unusual placement of tracheal stenosis; Flow-controlled ventilation (FCV) in patients with unusual placement of tracheal stenosis	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

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

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Principal Investigator: Istnabul University, Istanbul University

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2022
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: March 14, 2022
• First Submitted That Met QC Criteria: March 31, 2022
• First Posted (Actual): April 8, 2022

Study Record Updates

• Last Update Posted (Actual): September 16, 2022
• Last Update Submitted That Met QC Criteria: September 15, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Covid-19; tracheal stenosis; prolonged intubation,
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pathological Conditions, Anatomical; Tracheal Diseases; Constriction, Pathologic; Tracheal Stenosis
• Other Study ID Numbers: 2021/1958

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No