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Clinical Trials/NCT04625400
NCT04625400
Unknown
Not Applicable

Role of Bronchoscopy in Assessment of Patients With Post-intubation Tracheal Stenosis

Assiut University0 sites87 target enrollmentJanuary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tracheal Stenosis
Sponsor
Assiut University
Enrollment
87
Primary Endpoint
tracheal stenosis incidence in ICU cases after mechanical ventilation
Last Updated
5 years ago

Overview

Brief Summary

  1. To estimate the importance of bronchoscopic treatment of tracheal stenosis and its effectiveness and safety.
  2. To diagnose and evaluate tracheal stenosis characteristics as location, vertical extension and severity of obstruction.

Detailed Description

Post intubation tracheal stenosis (PI) was recognized in 1880, after prolonged endotracheal intubation in 4 patients with upper airway obstruction.The most common causes of acquired tracheal stenosis are endotracheal intubation and tracheostomy. Tracheal stenosis is a surgical problem managed non operatively by bronchoscopic dilation, endoluminal treatment with lasers, and stenting. Bronchoscopic management have a good success rate. PI and post tracheostomy stenosis (PT) are recognized with an 4.9 cases per million per year in the general population. Prolonged intubation can result in tracheal stenosis at various levels within the trachea.Tracheal stenosis occurs at the endotracheal tube cuff site in one third of the reported PI cases \[9\] and appears as a web-like fibrous. The mainly postulated cause is loss of regional blood flow.This injury begins within the first hours of intubation, and healing of the damaged areas within 3 to 6 weeks. Large volume, low pressure cuffs has reduced the occurrence of cuff injury.Patients in the ICU are common to have respiratory involvement, with 30-50% of the admissions requiring the use of mechanical ventilation.Flexible bronchoscopy has become the procedure of choice in most examinations of the tracheobronchial tree.The incidence of PI tracheal stenosis ranges from 6-21% and following tracheostomy ranges from 0.6-21%.

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
April 1, 2023
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohamed Kamal Darwish

Specialist , chest department and tuberculosis

Assiut University

Eligibility Criteria

Inclusion Criteria

  • Meticulous History and Clinical Examination
  • Chest x-Ray (CXR)
  • Flexible bronchoscopy
  • Rigid Bronchoscopy (when needed).

Exclusion Criteria

  • Patient refusal.
  • Any coagulation disorder.
  • Untreatable life-threatening arrhythmias.
  • Allergy to anaesthesia.
  • Poor general condition.

Outcomes

Primary Outcomes

tracheal stenosis incidence in ICU cases after mechanical ventilation

Time Frame: 2 years

incidence of tracheal stenosis among ICU cases after mechanical ventilation assessed by flexible bronchoscope measured by numbers.(patients/year)

Secondary Outcomes

  • the location, degree of tracheal stenosis characteristics.(2 years)

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