Back to results

Airway Management During Unusual Tracheal Stenosis

Primary Purpose

Tracheal Stenosis

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Flow Controlled Ventilation

About this trial

This is an interventional treatment trial for Tracheal Stenosis focused on measuring prolonged intubation,, tracheal stenosis, Covid-19

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Istanbul University, Department of Anesthesiology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

airway management and ventilation in patients with unusual placement of tracheal stenosis

Arm Description

Flow-controlled ventilation (FCV) in patients with unusual placement of tracheal stenosis

Outcomes

Primary Outcome Measures

PCO2

blood partial pressure of carbondioxide

PO2

blood partial pressure of oxygen

Secondary Outcome Measures

EtCO2

end-tidal carbondioxide measurement

length of intubation due to Covid-19 Pnomonia

time from intubation to extubation in ICU

sPO2

peripheral oxygen saturation

Myers-Cotton grading scale (1/2/3)

The grade of tracheal stenosis

VAS (Visual Analogue Scale) score (between 0 to 10 points)

surgeons' satisfaction(VAS 0=the worst view, 10= the best view)

Full Information

NCT ID

NCT05317923

First Posted

March 14, 2022

Last Updated

September 15, 2022

Sponsor

Istanbul University

1. Study Identification

Unique Protocol Identification Number

NCT05317923

Brief Title

Airway Management During Unusual Tracheal Stenosis

Official Title

Airway Management During Unusual Tracheal Stenosis: A Clinical Feasibility Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

March 14, 2022 (Actual)

Primary Completion Date

June 30, 2022 (Actual)

Study Completion Date

September 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tracheal Stenosis

Keywords

prolonged intubation,, tracheal stenosis, Covid-19

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

airway management and ventilation in patients with unusual placement of tracheal stenosis

Arm Type

Experimental

Arm Description

Flow-controlled ventilation (FCV) in patients with unusual placement of tracheal stenosis

Intervention Type

Other

Intervention Name(s)

Flow Controlled Ventilation

Intervention Description

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

Primary Outcome Measure Information:

Title

PCO2

Description

blood partial pressure of carbondioxide

Time Frame

PCO2 value at baseline just before entubation, peroperative 5, 15, 30, 45 minutes after induction, and before the extubation through surgery completion

Title

PO2

Description

blood partial pressure of oxygen

Time Frame

PO2 value at baseline just before entubation, peroperative 5, 15, 30, 45 minutes after induction, and before the extubation through surgery completion

Secondary Outcome Measure Information:

Title

EtCO2

Description

end-tidal carbondioxide measurement

Time Frame

EtCO2 value at baseline just before entubation, peroperative 5, 15, 30, 45 minutes after induction, and before the extubation through surgery completion

Title

length of intubation due to Covid-19 Pnomonia

Description

time from intubation to extubation in ICU

Time Frame

postoperative period (up to 1 year)

Title

sPO2

Description

peripheral oxygen saturation

Time Frame

SPO2 value at baseline, peroperative 5, 15, 30, 45 minutes after induction, and before the extubation through surgery completion

Title

Myers-Cotton grading scale (1/2/3)

Description

The grade of tracheal stenosis

Time Frame

before the surgery

Title

VAS (Visual Analogue Scale) score (between 0 to 10 points)

Description

surgeons' satisfaction(VAS 0=the worst view, 10= the best view)

Time Frame

during surgery through surgery completion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Istnabul University

Organizational Affiliation

Istanbul University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Istanbul University, Department of Anesthesiology

City

Istanbul

ZIP/Postal Code

34093

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Airway Management During Unusual Tracheal Stenosis

We'll reach out to this number within 24 hrs