Clinical trial NCT04625400: Role of Bronchoscopy in Assessment of Patients With Post-intubation Tracheal Stenosis
Official title: Role of Bronchoscopy in Assessment of Patients With Post-intubation Tracheal Stenosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tracheal Stenosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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%.

Eligibility criteria: Inclusion Criteria:

1. Meticulous History and Clinical Examination
2. Chest x-Ray (CXR)
3. Spirometry
4. Flexible bronchoscopy
5. Rigid Bronchoscopy (when needed).

Exclusion Criteria:

1. Patient refusal.
2. Any coagulation disorder.
3. Untreatable life-threatening arrhythmias.
4. Allergy to anaesthesia.
5. Poor general condition.

Primary outcomes:
measure: tracheal stenosis incidence in ICU cases after mechanical ventilation
timeFrame: 2 years
Secondary outcomes:
measure: the location, degree of tracheal stenosis characteristics.
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: assuit university hospital
name: Rafaat T El-Sokry, professor
role: STUDY_DIRECTOR
References:
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