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

November 10, 2020 updated by: Mohamed Kamal Darwish, Assiut University
  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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

87

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: post intubation tracheal stenosis patients
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.
Bronchoscopy in Assessment of Patients With Post-intubation Tracheal Stenosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the location, degree of tracheal stenosis characteristics.
Time Frame: 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.
2 years

Collaborators and Investigators

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

Investigators

  • Study Director: Rafaat T El-Sokry, professor, Assuit University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

January 1, 2021

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

October 9, 2020

First Submitted That Met QC Criteria

November 10, 2020

First Posted (Actual)

November 12, 2020

Study Record Updates

Last Update Posted (Actual)

November 12, 2020

Last Update Submitted That Met QC Criteria

November 10, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

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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