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

Not Applicable

• Conditions: Tracheal Stenosis
• Interventions: Diagnostic Test: bronchoscope

• Registration Number: NCT04625400
• Lead Sponsor: Assiut University

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%.

Study Timeline

• Study First Submitted: 2020-10-09
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-10
• Last Update Submitted: 2020-11-10
• Study First Posted: 2020-11-12
• Last Update Posted: 2020-11-12
• Study Start: 2021-01-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 87

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
post intubation tracheal stenosis patients	bronchoscope	all ICU patients who were mechanically ventilated will be assessed for the possibility of presence of tracheal stenosis using spirometery and dyspnea will be assessed using (mMRC) score, chest X-ray to assess the location of tracheal stenosis and finally flexible bronchoscopy to confirm the presence of stenosis and identify the proper management.

Primary Outcome Measures

Name	Time	Method
tracheal stenosis incidence in ICU cases after mechanical ventilation	2 years	incidence of tracheal stenosis among ICU cases after mechanical ventilation assessed by flexible bronchoscope measured by numbers.(patients/year)

Secondary Outcome Measures

Name	Time	Method
the location, degree of tracheal stenosis characteristics.	2 years	1. identify the location of stenosis: - upper-third of the trachea (I) from 1-4 cm middle-third of the trachea (II) from 5-8 cm lower-third of the trachea (III)from 9-12 cm by Chest x-Ray (Chest x-ray); 2. the diameter of trachea was assessed by cm.; 3. Spirometry by measuring the ratio of forced expiratory volume (FEV 1 ) in 1 second to peak expiratory flow (PEF).; 4. FEV 1 measured in in milliliter ,FEV1/FVC ratio.