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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tracheal Stenosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

    First Posted
    October 9, 2020
    Last Updated
    November 10, 2020
    Sponsor
    Assiut University
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    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
    Puchalski J, Musani AI. Tracheobronchial stenosis: causes and advances in management. Clin Chest Med. 2013 Sep;34(3):557-67. doi: 10.1016/j.ccm.2013.05.002. Epub 2013 Jul 3.
    Results Reference
    result
    PubMed Identifier
    19084420
    Citation
    Galluccio G, Lucantoni G, Battistoni P, Paone G, Batzella S, Lucifora V, Dello Iacono R. Interventional endoscopy in the management of benign tracheal stenoses: definitive treatment at long-term follow-up. Eur J Cardiothorac Surg. 2009 Mar;35(3):429-33; discussion 933-4. doi: 10.1016/j.ejcts.2008.10.041. Epub 2008 Dec 11.
    Results Reference
    result
    PubMed Identifier
    17695689
    Citation
    Cavaliere S, Bezzi M, Toninelli C, Foccoli P. Management of post-intubation tracheal stenoses using the endoscopic approach. Monaldi Arch Chest Dis. 2007 Jun;67(2):73-80. doi: 10.4081/monaldi.2007.492.
    Results Reference
    result
    PubMed Identifier
    8521696
    Citation
    Mehta AC, Harris RJ, De Boer GE. Endoscopic management of benign airway stenosis. Clin Chest Med. 1995 Sep;16(3):401-13.
    Results Reference
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    PubMed Identifier
    8365273
    Citation
    Mehta AC, Lee FY, Cordasco EM, Kirby T, Eliachar I, De Boer G. Concentric tracheal and subglottic stenosis. Management using the Nd-YAG laser for mucosal sparing followed by gentle dilatation. Chest. 1993 Sep;104(3):673-7. doi: 10.1378/chest.104.3.673.
    Results Reference
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    PubMed Identifier
    17883582
    Citation
    Nouraei SA, Ma E, Patel A, Howard DJ, Sandhu GS. Estimating the population incidence of adult post-intubation laryngotracheal stenosis. Clin Otolaryngol. 2007 Oct;32(5):411-2. doi: 10.1111/j.1749-4486.2007.01484.x. No abstract available.
    Results Reference
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    PubMed Identifier
    16949978
    Citation
    Poetker DM, Ettema SL, Blumin JH, Toohill RJ, Merati AL. Association of airway abnormalities and risk factors in 37 subglottic stenosis patients. Otolaryngol Head Neck Surg. 2006 Sep;135(3):434-7. doi: 10.1016/j.otohns.2006.04.013.
    Results Reference
    result
    PubMed Identifier
    4939117
    Citation
    Pearson FG, Andrews MJ. Detection and management of tracheal stenosis following cuffed tube tracheostomy. Ann Thorac Surg. 1971 Oct;12(4):359-74. doi: 10.1016/s0003-4975(10)65137-5. No abstract available.
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    PubMed Identifier
    7877309
    Citation
    Grillo HC, Donahue DM, Mathisen DJ, Wain JC, Wright CD. Postintubation tracheal stenosis. Treatment and results. J Thorac Cardiovasc Surg. 1995 Mar;109(3):486-92; discussion 492-3. doi: 10.1016/S0022-5223(95)70279-2.
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    PubMed Identifier
    3398673
    Citation
    Weymuller EA Jr. Laryngeal injury from prolonged endotracheal intubation. Laryngoscope. 1988 Aug;98(8 Pt 2 Suppl 45):1-15. doi: 10.1288/00005537-198808001-00001.
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    PubMed Identifier
    12755310
    Citation
    Wain JC. Postintubation tracheal stenosis. Chest Surg Clin N Am. 2003 May;13(2):231-46. doi: 10.1016/s1052-3359(03)00034-6.
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    PubMed Identifier
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    Citation
    Ciccone AM, De Giacomo T, Venuta F, Ibrahim M, Diso D, Coloni GF, Rendina EA. Operative and non-operative treatment of benign subglottic laryngotracheal stenosis. Eur J Cardiothorac Surg. 2004 Oct;26(4):818-22. doi: 10.1016/j.ejcts.2004.06.020.
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    PubMed Identifier
    20689914
    Citation
    Estella A. Bronchoalveolar lavage for pandemic influenza A (H1N1)v pneumonia in critically ill patients. Intensive Care Med. 2010 Nov;36(11):1976-7. doi: 10.1007/s00134-010-2009-z. Epub 2010 Aug 6. No abstract available.
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    PubMed Identifier
    1545649
    Citation
    Anand VK, Alemar G, Warren ET. Surgical considerations in tracheal stenosis. Laryngoscope. 1992 Mar;102(3):237-43. doi: 10.1288/00005537-199203000-00002.
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    PubMed Identifier
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    Citation
    Grillo HC, Cooper JD, Geffin B, Pontoppidan H. A low-pressure cuff for tracheostomy tubes to minimize tracheal injury. A comparative clinical trial. J Thorac Cardiovasc Surg. 1971 Dec;62(6):898-907. No abstract available.
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    Role of Bronchoscopy in Assessment of Patients With Post-intubation Tracheal Stenosis

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