Airway Management During Unusual Tracheal Stenosis

NCT05317923 | Completed

• 1 other identifier: 2021/1958
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Tracheal Stenosis

Keywords

prolonged intubation,; tracheal stenosis; Covid-19

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• EtCO2

  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

  postoperative period (up to 1 year)

• sPO2

  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)

  before the surgery

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

  during surgery through surgery completion

Study Arms (1)

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

EXPERIMENTAL

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

Other: Flow Controlled Ventilation

Interventions

Flow Controlled Ventilation OTHER

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

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University, Department of Anesthesiology

Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tracheal Stenosis; COVID-19

Condition Hierarchy (Ancestors)

Tracheal Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases

Study Officials

• Istnabul University

  Istanbul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: April 8, 2022
• Study Start: March 14, 2022
• Primary Completion: June 30, 2022
• Study Completion: September 1, 2022
• Last Updated: September 16, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)