Relationship Between Post-Intubation Tracheal Stenosis and Covid-19

Completed

• Conditions: Tracheal Stenosis; Intensive Care Unit; COVID-19; Post-Intubation Subglottic Stenosis
• Interventions: Procedure: tracheal stenosis follow-up file

• Registration Number: NCT05682651
• Lead Sponsor: Ankara City Hospital Bilkent

Brief Summary

Tracheal stenosis (TS) is a serious complication that occurs in approximately 6-22% of patients due to prolonged endotracheal intubation. Cuff hyperinflation of the endotracheal tube, use of large tubes, advanced age, female gender, smoking, obesity, and diabetes are risk factors for TS. The most common and serious complication in COVID-19 patients is acute respiratory distress syndrome (ARDS), which requires oxygen and ventilation treatments. In the literature, it is reported that 9.8-15.2% of patients need invasive mechanical ventilation (IMV). The concern of aerosol formation and prone position applications that emerged with the coronavirus pandemic caused delays in tracheostomy decisions and the use of uncontrolled high cuff pressures, paving the way for TS. The capillary perfusion pressure of the tracheal mucosa ranges from 20 to 30 mmHg. A cuff pressure of the endotracheal tube above 30 mmHg causes mucosal ischemia. Cartilage inflammation due to ischemic injury may be partial or full thickness. Depending on the degree of inflammation in the affected tracheal segments, stenosis and even perforation may develop.

It is aimed to determine the etiological causes, to determine how much of the total TS cases covid-related TS constitutes, to examine the treatments and patient results in covid/non-covid TS.

This study will contribute to the measures that can be taken during and after the care process in the intensive care unit.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-28
• Study First Submitted: 2023-01-07
• Study First Submitted QC: 2023-01-11
• Study First Posted: 2023-01-12
• Primary Completion: 2023-04-28
• Study Completion: 2023-05-28
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-01
• Last Update Posted: 2024-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• Patients older than 18 years

Exclusion Criteria

• Patients undergoing surgical procedures for malignancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tracheal Stenosis with Covid-19	tracheal stenosis follow-up file	Patients' age, gender, American Society of Anesthesiologists (ASA) classification, comorbidities, etiologic cause, intubation time, type of surgery, length of hospital stay, and morbidity/mortality information will be recorded.
Tracheal Stenosis with Non-Covid-19	tracheal stenosis follow-up file	Patients' age, gender, American Society of Anesthesiologists (ASA) classification, comorbidities, etiologic cause, intubation time, type of surgery, length of hospital stay, and morbidity/mortality information will be recorded.

Primary Outcome Measures

Name	Time	Method
Intubation time	Up to 3 months	Duration of intubation of patients (in days)
Morbidity/mortality	Up to 2 months	Morbidity/mortality status of the patients within 3 months
Length of hospital stay	Up to 3 months	The hospital stay of the patients will be recorded (in days)

Trial Locations

Locations (1)

Ankara City Hospital; 🇹🇷 Çankaya, Ankara, Turkey