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

Tracheal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04625400
• Other study ID #: Tracheal stenosis
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: April 1, 2023

Study information

• Verified date: November 2020
• Source: Assiut University
• Contact: Mohamed k Mohamed, phd
• Phone: 01098989377
• Email: mkdarwish90[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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%.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 87
• Est. completion date: April 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Tracheal Stenosis

Intervention

Diagnostic Test:
• bronchoscope
Bronchoscopy in Assessment of Patients With Post-intubation Tracheal Stenosis.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (15)

Anand VK, Alemar G, Warren ET. Surgical considerations in tracheal stenosis. Laryngoscope. 1992 Mar;102(3):237-43. — View 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. — View 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. — View 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. — View 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; d — View 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. — View 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. — View Citation

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

Pearson FG, Andrews MJ. Detection and management of tracheal stenosis following cuffed tube tracheostomy. Ann Thorac Surg. 1971 Oct;12(4):359-74. — View 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. — View 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. Review. — View Citation

Wain JC. Postintubation tracheal stenosis. Chest Surg Clin N Am. 2003 May;13(2):231-46. Review. — View Citation

Weymuller EA Jr. Laryngeal injury from prolonged endotracheal intubation. Laryngoscope. 1988 Aug;98(8 Pt 2 Suppl 45):1-15. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	2 years