Relationship Between Post-Intubation Tracheal Stenosis and Covid-19

February 1, 2024 updated by: Nilgün Zengin, Ankara City Hospital Bilkent

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

101

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Ankara
      • Çankaya, Ankara, Turkey, 06290
        • Ankara City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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.

Description

Inclusion Criteria:

  • Patients older than 18 years

Exclusion Criteria:

  • Patients undergoing surgical procedures for malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
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
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 28, 2022

Primary Completion (Actual)

April 28, 2023

Study Completion (Actual)

May 28, 2023

Study Registration Dates

First Submitted

January 7, 2023

First Submitted That Met QC Criteria

January 11, 2023

First Posted (Actual)

January 12, 2023

Study Record Updates

Last Update Posted (Actual)

February 2, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E.Kurul-E1-22-3142

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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