Relationship Between Post-Intubation Tracheal Stenosis and Covid-19

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05682651
• Other study ID #: E.Kurul-E1-22-3142
• Status: Completed
• Start date: December 28, 2022
• Est. completion date: May 28, 2023

Study information

• Verified date: February 2024
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: May 28, 2023
• Est. primary completion date: April 28, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients older than 18 years

Exclusion Criteria:

• Patients undergoing surgical procedures for malignancy

Related Conditions & MeSH terms

• Constriction, Pathologic
• COVID-19
• Intensive Care Unit
• Tracheal Stenosis

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Turkey	Ankara City Hospital	Çankaya	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intubation time	Duration of intubation of patients (in days)	Up to 3 months
Primary	Morbidity/mortality	Morbidity/mortality status of the patients within 3 months	Up to 2 months
Primary	Length of hospital stay	The hospital stay of the patients will be recorded (in days)	Up to 3 months