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Tracheal StenosisNCT04625400

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

A study testing bronchoscope in people with Tracheal Stenosis, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Tracheal Stenosis
What is being tested?
bronchoscope
Could I receive a placebo?
No, everyone receives an active treatment
How many people
87 participants
Where
No sites listed yet
Study dates
1 Jan 2021to 1 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

Mohamed k Mohamed, phd contact

01098989377

mkdarwish90@hotmail.com

Rafaat T El-Sokry, professor contact

01006155517

Elsokkary100@yahoo.com

About this study

  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.
Read the 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%.

Being tested
bronchoscope
Medical subject headings
Tracheal Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bronchoscopeDiagnostic test

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

Study groups in NCT04625400
Study groupRoleWhat they receive
post intubation tracheal stenosis patientsExperimentalall 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.
Receives: Diagnostic Test: bronchoscope

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 2 years

Secondary outcomes (1)

  1. the location, degree of tracheal stenosis characteristics.

    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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2020
  2. Study start1 Jan 2021 (estimated)
  3. Primary completion1 Jan 2023 (estimated)
  4. Study completion1 Apr 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
87 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04625400
Sponsor's protocol ID
Tracheal stenosis
Status last verified
Nov 2020
First submitted
9 Oct 2020
Last updated
12 Nov 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 23993823

  • 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.

    PubMed 19084420

  • 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.

    PubMed 17695689

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

    PubMed 8521696

  • 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.

    PubMed 8365273

  • 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.

    PubMed 17883582

  • 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.

    PubMed 16949978

  • 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.

    PubMed 4939117

  • 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.

    PubMed 7877309

  • 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.

    PubMed 3398673

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

    PubMed 12755310

  • 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.

    PubMed 15450579

  • 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.

    PubMed 20689914

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

    PubMed 1545649

  • 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.

    PubMed 4942973

Questions about this trial

What is this clinical trial studying?

A study testing bronchoscope in people with Tracheal Stenosis, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mohamed k Mohamed, phd (01098989377, mkdarwish90@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

tracheal stenosis incidence in ICU cases after mechanical ventilation (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04625400, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.

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