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Not yet recruitingNCT06526780Updated Jul 30, 2024

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

An interventional study of Bronchscopy in Airway Disease, sponsored by Assiut University. Not yet recruiting. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2024-07-30.

Sponsored by Assiut University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
1 Month to 18 Years
Sex
All
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Study summary

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

Read the detailed description

A correct diagnosis is necessary for effective therapy of airway illness. Usually necessary for these invasive treatments. The "gold standard" for tracheobronchial pathology identification and diagnosis is rigid or fiber optic bronchoscopy. Fiber Optic is a procedure that is generally safe, although it can have negative effects, particularly in patients who are at greater risk. Therefore, it is important to continually develop and improve non-invasive procedures that enable airway examination.

The laryngotracheal and bronchial airway is affected by a wide range of diseases, and imaging is essential for assessing these anomalies. The location, scope, and type of these lesions may be determined with great accuracy using computed tomography.

Bronchoscopy allows direct visualization of trachea and bronchi by rigid open tube bronchoscope or flexible fiber optic scope. Detailed evaluation of airways with bronchoscopy offers advantages over other diagnostic tools and allows interventional procedures such as biopsy of lesions, removal of foreign bodies, dilatations of stenosis and obtaining samples for cytological and microbiologic analysis.

Bronchoscopy can be performed either by rigid or flexible instruments depending on the needs of patients. The pediatric airway is notably different from adults. It is smaller in size, larynx and tracheal proportion is more as compared to adults and epiglottis is more posterior and narrower .

Fiber Optic bronchoscopy with or without bronchoalveolar lavage is particularly important in the diagnosis and treatment of specific respiratory problems in critically ill infants and children hospitalized in the pediatric Intensive care unit.These comprise situations such as segmental lung collapse, pulmonary infections including community-acquired and ventilator-associated pneumonia, pulmonary infections in immunocompromised hosts, and pulmonary bleeding. In addition, bronchscopy has a special role in airway problems in very sick pediatric patients. It may be crucial in intubation of the difficult airways and in the assessment of airway anomalies.

There are various indications for bronchoscopy: persistent stridor , congenital, anatomical, or acquired anomalies, persistent wheezing, hemoptysis, persistent or recurring atelectasis, persistent or recurring pneumonia, and localized hyperinflation. Other uses of bronchoscopy are bronchoalveolar lavage , getting biopsy samples, and aspiration of secretions. Examples of therapeutic bronchoscopy are administering medications and removing foreign bodies.

Absolute contraindications for bronchoscopy include severe hypoxemia, hemodynamic instability, and uncorrected hemorrhagic diathesis. Severe pulmonary hypertension and congenital cyanotic cardiomyopathy with increased bronchial collateral circulation are relative contraindications. In addition, instabilities in the cervical spine or atlanto occipital transition are considered relative contraindications for rigid bronchoscopy.

The common complication of bronchoscopy is related to anesthesia, mechanical trauma ( epistaxis , pneumothorax, and hemoptysis), hypoxemia, laryngospasm, post-lavage fever, and infection.

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Conditions studied

  • Airway Disease

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03

In context

Critical Illness

1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.

This study's planned enrollment of 100 is above the median of 90 across 979 interventional studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Month to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Study group

    Critical ill children with airway diseases

    Procedure: Bronchscopy

Interventions

  • ProcedureBronchscopy

    Bronchscopy in critical ill children with airway diseases

    Also known as: chest computed tomography scan with virtual bronchscopy

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What researchers measure

Primary outcomes

  1. Visualization of airway abnormalities by bronchscopy

    Direct visualization of airway by bronchscopy

    Time frame: During procedure

  2. Visualization of airway abnormalities by computed tomography scan

    Assessment of airway by computed tomography scan with virtual bronchscopy

    Time frame: During procedure

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 14582925 ↗
  • 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. PubMed 24822151 ↗
  • Wood RE. Evaluation of the upper airway in children. Curr Opin Pediatr. 2008 Jun;20(3):266-71. doi: 10.1097/MOP.0b013e3282ff631e. PubMed 18475094 ↗
  • 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. PubMed 19009620 ↗
  • 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. PubMed 21513991 ↗
  • 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. PubMed 19606008 ↗
  • 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. PubMed 25932763 ↗
  • 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. PubMed 34098560 ↗
  • Rosenthal M. Bronchoscopy and infection. Paediatr Respir Rev. 2003 Jun;4(2):143-6. doi: 10.1016/s1526-0542(03)00025-3. PubMed 12758052 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06526780
Lead sponsor
Assiut University
Responsible party
AA Nagy (Principal investigator, Assiut University) — Principal investigator
First posted
Jul 30, 2024
Start date
Nov 2024 (estimated)
Primary completion
Oct 2025 (estimated)
Completion
May 2026 (estimated)
Last update
Jul 30, 2024

Study contacts

Azza Ah Eltayeb
Contact
azeltayeb@aun.edu.eg
201006863277
Ismail L Mohamad
Contact
ismail231@aun.edu.eg
201063398967

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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