Role of Bronchoscopy in Assessment of Patients With Post-intubation Tracheal Stenosis
Primary Purpose
Tracheal Stenosis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
bronchoscope
Sponsored by
About this trial
This is an interventional prevention trial for Tracheal Stenosis
Eligibility Criteria
Inclusion Criteria:
- Meticulous History and Clinical Examination
- Chest x-Ray (CXR)
- Spirometry
- Flexible bronchoscopy
- Rigid Bronchoscopy (when needed).
Exclusion Criteria:
- Patient refusal.
- Any coagulation disorder.
- Untreatable life-threatening arrhythmias.
- Allergy to anaesthesia.
- Poor general condition.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
post intubation tracheal stenosis patients
Arm Description
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.
Outcomes
Primary Outcome Measures
tracheal stenosis incidence in ICU cases after mechanical ventilation
incidence of tracheal stenosis among ICU cases after mechanical ventilation assessed by flexible bronchoscope measured by numbers.(patients/year)
Secondary Outcome Measures
the location, degree of tracheal stenosis characteristics.
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)
the diameter of trachea was assessed by cm.
Spirometry by measuring the ratio of forced expiratory volume (FEV 1 ) in 1 second to peak expiratory flow (PEF).
FEV 1 measured in in milliliter ,FEV1/FVC ratio.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04625400
Brief Title
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
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Anticipated)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To estimate the importance of bronchoscopic treatment of tracheal stenosis and its effectiveness and safety.
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%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tracheal Stenosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
87 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
post intubation tracheal stenosis patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
bronchoscope
Intervention Description
Bronchoscopy in Assessment of Patients With Post-intubation Tracheal Stenosis.
Primary Outcome Measure Information:
Title
tracheal stenosis incidence in ICU cases after mechanical ventilation
Description
incidence of tracheal stenosis among ICU cases after mechanical ventilation assessed by flexible bronchoscope measured by numbers.(patients/year)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
the location, degree of tracheal stenosis characteristics.
Description
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)
the diameter of trachea was assessed by cm.
Spirometry by measuring the ratio of forced expiratory volume (FEV 1 ) in 1 second to peak expiratory flow (PEF).
FEV 1 measured in in milliliter ,FEV1/FVC ratio.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meticulous History and Clinical Examination
Chest x-Ray (CXR)
Spirometry
Flexible bronchoscopy
Rigid Bronchoscopy (when needed).
Exclusion Criteria:
Patient refusal.
Any coagulation disorder.
Untreatable life-threatening arrhythmias.
Allergy to anaesthesia.
Poor general condition.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed k Mohamed, phd
Phone
01098989377
Email
mkdarwish90@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rafaat T El-Sokry, professor
Phone
01006155517
Email
Elsokkary100@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafaat T El-Sokry, professor
Organizational Affiliation
assuit university hospital
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
23993823
Citation
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Results Reference
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Citation
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Citation
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PubMed Identifier
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Citation
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8365273
Citation
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Citation
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Citation
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Citation
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Citation
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Citation
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Role of Bronchoscopy in Assessment of Patients With Post-intubation Tracheal Stenosis
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