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

NCT ID: NCT04625400

Last Updated: 2020-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-04-01

Brief Summary

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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.

Detailed Description

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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%.

Conditions

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Tracheal Stenosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

bronchoscope

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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bronchoscope

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Kamal Darwish

Specialist , chest department and tuberculosis

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rafaat T El-Sokry, professor

Role: STUDY_DIRECTOR

assuit university hospital

Central Contacts

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Mohamed k Mohamed, phd

Role: CONTACT

Phone: 01098989377

Email: [email protected]

Rafaat T El-Sokry, professor

Role: CONTACT

Phone: 01006155517

Email: [email protected]

References

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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.

Reference Type RESULT
PMID: 23993823 (View on PubMed)

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.

Reference Type RESULT
PMID: 19084420 (View on PubMed)

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.

Reference Type RESULT
PMID: 17695689 (View on PubMed)

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

Reference Type RESULT
PMID: 8521696 (View on PubMed)

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.

Reference Type RESULT
PMID: 8365273 (View on PubMed)

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.

Reference Type RESULT
PMID: 17883582 (View on PubMed)

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.

Reference Type RESULT
PMID: 16949978 (View on PubMed)

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.

Reference Type RESULT
PMID: 4939117 (View on PubMed)

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.

Reference Type RESULT
PMID: 7877309 (View on PubMed)

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.

Reference Type RESULT
PMID: 3398673 (View on PubMed)

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

Reference Type RESULT
PMID: 12755310 (View on PubMed)

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.

Reference Type RESULT
PMID: 15450579 (View on PubMed)

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.

Reference Type RESULT
PMID: 20689914 (View on PubMed)

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

Reference Type RESULT
PMID: 1545649 (View on PubMed)

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.

Reference Type RESULT
PMID: 4942973 (View on PubMed)

Other Identifiers

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Tracheal stenosis

Identifier Type: -

Identifier Source: org_study_id