NCT04625400

Brief Summary

  1. 1.To estimate the importance of bronchoscopic treatment of tracheal stenosis and its effectiveness and safety.
  2. 2.To diagnose and evaluate tracheal stenosis characteristics as location, vertical extension and severity of obstruction.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 12, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

November 12, 2020

Status Verified

November 1, 2020

Enrollment Period

2 years

First QC Date

October 9, 2020

Last Update Submit

November 10, 2020

Conditions

Tracheal Stenosis

Outcome Measures

Primary Outcomes (1)

  • 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)

    2 years

Secondary Outcomes (1)

  • the location, degree of tracheal stenosis characteristics.

    2 years

Study Arms (1)

post intubation tracheal stenosis patients

EXPERIMENTAL

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.

Diagnostic Test: bronchoscope

Interventions

bronchoscopeDIAGNOSTIC_TEST

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

post intubation tracheal stenosis patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meticulous History and Clinical Examination
  • Chest x-Ray (CXR)
  • Spirometry
  • Flexible bronchoscopy
  • Rigid Bronchoscopy (when needed).

You may not qualify if:

  • Patient refusal.
  • Any coagulation disorder.
  • Untreatable life-threatening arrhythmias.
  • Allergy to anaesthesia.
  • Poor general condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (15)

  • 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.

    PMID: 23993823RESULT

  • 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.

    PMID: 19084420RESULT

  • 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.

    PMID: 17695689RESULT

  • Mehta AC, Harris RJ, De Boer GE. Endoscopic management of benign airway stenosis. Clin Chest Med. 1995 Sep;16(3):401-13.

    PMID: 8521696RESULT

  • 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.

    PMID: 8365273RESULT

  • 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.

    PMID: 17883582RESULT

  • 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.

    PMID: 16949978RESULT

  • 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.

    PMID: 4939117RESULT

  • 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.

    PMID: 7877309RESULT

  • 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.

    PMID: 3398673RESULT

  • Wain JC. Postintubation tracheal stenosis. Chest Surg Clin N Am. 2003 May;13(2):231-46. doi: 10.1016/s1052-3359(03)00034-6.

    PMID: 12755310RESULT

  • 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.

    PMID: 15450579RESULT

  • 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.

    PMID: 20689914RESULT

  • Anand VK, Alemar G, Warren ET. Surgical considerations in tracheal stenosis. Laryngoscope. 1992 Mar;102(3):237-43. doi: 10.1288/00005537-199203000-00002.

    PMID: 1545649RESULT

  • 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.

    PMID: 4942973RESULT

MeSH Terms

Conditions

Tracheal Stenosis

Condition Hierarchy (Ancestors)

Tracheal DiseasesRespiratory Tract Diseases

Study Officials

  • Rafaat T El-Sokry, professor

    assuit university hospital

    STUDY DIRECTOR

Central Study Contacts

Mohamed k Mohamed, phd

CONTACT

01098989377mkdarwish90@hotmail.com

Rafaat T El-Sokry, professor

CONTACT

01006155517Elsokkary100@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist , chest department and tuberculosis

Study Record Dates

First Submitted

October 9, 2020

First Posted

November 12, 2020

Study Start

January 1, 2021

Primary Completion

January 1, 2023

Study Completion

April 1, 2023

Last Updated

November 12, 2020

Record last verified: 2020-11