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Clinical Trials/NCT05682651
NCT05682651
Completed
Not Applicable

Etiological Investigation of 'Post-Intubation Tracheal Stenosis' Cases Requiring Intervention: 2-year Case Review

Ankara City Hospital Bilkent1 site in 1 country101 target enrollmentDecember 28, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tracheal Stenosis
Sponsor
Ankara City Hospital Bilkent
Enrollment
101
Locations
1
Primary Endpoint
Intubation time
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 28, 2022
End Date
May 28, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nilgün Zengin

Principal İnvestigator

Ankara City Hospital Bilkent

Eligibility Criteria

Inclusion Criteria

  • Patients older than 18 years

Exclusion Criteria

  • Patients undergoing surgical procedures for malignancy

Outcomes

Primary Outcomes

Intubation time

Time Frame: Up to 3 months

Duration of intubation of patients (in days)

Morbidity/mortality

Time Frame: Up to 2 months

Morbidity/mortality status of the patients within 3 months

Length of hospital stay

Time Frame: Up to 3 months

The hospital stay of the patients will be recorded (in days)

Study Sites (1)

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