Relationship Between Post-Intubation Tracheal Stenosis and Covid-19

NCT05682651 | Completed

• 1 other identifier: E.Kurul-E1-22-3142
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Tracheal Stenosis; COVID-19; Post-Intubation Subglottic Stenosis; Intensive Care Unit

Outcome Measures

Primary Outcomes (3)

• Intubation time

  Duration of intubation of patients (in days)

  Up to 3 months

• Morbidity/mortality

  Morbidity/mortality status of the patients within 3 months

  Up to 2 months

• Length of hospital stay

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

  Up to 3 months

Study Arms (2)

Tracheal Stenosis with Covid-19

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.

Procedure: tracheal stenosis follow-up file

Tracheal Stenosis with Non-Covid-19

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.

Procedure: tracheal stenosis follow-up file

Interventions

tracheal stenosis follow-up file PROCEDURE

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 Covid-19; Tracheal Stenosis with Non-Covid-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients older than 18 years of age and without a history of malignancy who developed post-intubation tracheal stenosis are included in the study.

You may qualify if:

• Patients older than 18 years

You may not qualify if:

• Patients undergoing surgical procedures for malignancy

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Çankaya, Ankara, 06290, 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 Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal İnvestigator

Study Record Dates

• First Submitted: January 7, 2023
• First Posted: January 12, 2023
• Study Start: December 28, 2022
• Primary Completion: April 28, 2023
• Study Completion: May 28, 2023
• Last Updated: February 2, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)