Bronchoscopy Versus Imaging in Diagnosis of Airway Diseases in Critically Ill Children

NCT06526780 | Not Yet Recruiting

• 1 other identifier: BVIAD
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients with suspected airway illness often go through a diagnostic assessment that includes chest radiographs, Computed tomography scans, and fiber optic bronchoscopy.

Conditions

Airway Disease

Outcome Measures

Primary Outcomes (2)

• Visualization of airway abnormalities by bronchscopy

  Direct visualization of airway by bronchscopy

  During procedure

• Visualization of airway abnormalities by computed tomography scan

  Assessment of airway by computed tomography scan with virtual bronchscopy

  During procedure

Study Arms (1)

Study group

EXPERIMENTAL

Critical ill children with airway diseases

Procedure: Bronchscopy

Interventions

Bronchscopy PROCEDURE

Bronchscopy in critical ill children with airway diseases

Also known as: chest computed tomography scan with virtual bronchscopy

Study group

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 1 month: 18 years.
• Critically ill patients with suspected airway diseases for the following indications:
• Difficult intubation.
• extubation failure (defined as the replacement of an endotracheal tube within \<48 h after extubation).
• Persistent stridor. •Acute unexplained respiratory distress.• Localized hyperinflation.
• Suspected foreign body.
• Persistent and recurrent wheezes.
• Persistent and recurrent atelectasis.
• Unexplained hemoptysis

You may not qualify if:

• Age ( \< 1month and \> 18 years )
• Severe hypoxemia
• Hemodynamic instability
• Uncorrected bleeding diathesis
• Unresolved lung infection

Sponsors & Collaborators

• Assiut University: lead

Related Publications (9)

• Midulla F, de Blic J, Barbato A, Bush A, Eber E, Kotecha S, Haxby E, Moretti C, Pohunek P, Ratjen F; ERS Task Force. Flexible endoscopy of paediatric airways. Eur Respir J. 2003 Oct;22(4):698-708. doi: 10.1183/09031936.02.00113202.

  PMID: 14582925 BACKGROUND

• Sinha V, Gurnani D, Barot DA. A study of applications of rigid bronchoscopy in pediatric patients. Indian J Otolaryngol Head Neck Surg. 2014 Jun;66(2):142-4. doi: 10.1007/s12070-013-0667-1. Epub 2013 Jun 27.

  PMID: 24822151 RESULT

• Wood RE. Evaluation of the upper airway in children. Curr Opin Pediatr. 2008 Jun;20(3):266-71. doi: 10.1097/MOP.0b013e3282ff631e.

  PMID: 18475094 RESULT

• Davidson MG, Coutts J, Bell G. Flexible bronchoscopy in pediatric intensive care. Pediatr Pulmonol. 2008 Dec;43(12):1188-92. doi: 10.1002/ppul.20910.

  PMID: 19009620 RESULT

• Soong WJ, Shiao AS, Jeng MJ, Lee YS, Tsao PC, Yang CF, Soong YH. Comparison between rigid and flexible laser supraglottoplasty in the treatment of severe laryngomalacia in infants. Int J Pediatr Otorhinolaryngol. 2011 Jun;75(6):824-9. doi: 10.1016/j.ijporl.2011.03.016. Epub 2011 Apr 21.

  PMID: 21513991 RESULT

• Levin R, Kissoon N, Froese N. Fibreoptic and videoscopic indirect intubation techniques for intubation in children. Pediatr Emerg Care. 2009 Jul;25(7):473-9; quiz 480-2. doi: 10.1097/PEC.0b013e3181aba8c1.

  PMID: 19606008 RESULT

• Faro A, Wood RE, Schechter MS, Leong AB, Wittkugel E, Abode K, Chmiel JF, Daines C, Davis S, Eber E, Huddleston C, Kilbaugh T, Kurland G, Midulla F, Molter D, Montgomery GS, Retsch-Bogart G, Rutter MJ, Visner G, Walczak SA, Ferkol TW, Michelson PH; American Thoracic Society Ad Hoc Committee on Flexible Airway Endoscopy in Children. Official American Thoracic Society technical standards: flexible airway endoscopy in children. Am J Respir Crit Care Med. 2015 May 1;191(9):1066-80. doi: 10.1164/rccm.201503-0474ST.

  PMID: 25932763 RESULT

• Schramm D, Freitag N, Nicolai T, Wiemers A, Hinrichs B, Amrhein P, DiDio D, Eich C, Landsleitner B, Eber E, Hammer J; Special Interest Group on Pediatric Bronchoscopy of the Society for Pediatric Pneumology (GPP) and invited Societies involved in pediatric airway endoscopy. Pediatric Airway Endoscopy: Recommendations of the Society for Pediatric Pneumology. Respiration. 2021;100(11):1128-1145. doi: 10.1159/000517125. Epub 2021 Jun 7.

  PMID: 34098560 RESULT

• Rosenthal M. Bronchoscopy and infection. Paediatr Respir Rev. 2003 Jun;4(2):143-6. doi: 10.1016/s1526-0542(03)00025-3.

  PMID: 12758052 RESULT

Central Study Contacts

Azza Ah Eltayeb

CONTACT

201006863277; azeltayeb@aun.edu.eg

Ismail L Mohamad

CONTACT

201063398967; ismail231@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 30, 2024
• Study Start: November 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: May 1, 2026
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share