Relationship Between Post-Intubation Tracheal Stenosis and Covid-19

Sponsor
Ankara City Hospital Bilkent (Other)
Overall Status
Recruiting
CT.gov ID
NCT05682651
Collaborator
(none)
100
1
5
20.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: tracheal stenosis follow-up file

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Etiological Investigation of 'Post-Intubation Tracheal Stenosis' Cases Requiring Intervention: 2-year Case Review
Actual Study Start Date :
Dec 28, 2022
Anticipated Primary Completion Date :
Apr 28, 2023
Anticipated Study Completion Date :
May 28, 2023

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Intubation time [Up to 3 months]

    Duration of intubation of patients (in days)

  2. Morbidity/mortality [Up to 2 months]

    Morbidity/mortality status of the patients within 3 months

  3. Length of hospital stay [Up to 3 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Patients older than 18 years
Exclusion Criteria:
  • Patients undergoing surgical procedures for malignancy

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ankara City Hospital Çankaya Ankara Turkey 06290

Sponsors and Collaborators

  • Ankara City Hospital Bilkent

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nilgün Zengin, Principal İnvestigator, Ankara City Hospital Bilkent
ClinicalTrials.gov Identifier:
NCT05682651
Other Study ID Numbers:
  • E.Kurul-E1-22-3142
First Posted:
Jan 12, 2023
Last Update Posted:
Jan 12, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 12, 2023