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

July 24, 2024 updated by: AA Nagy, Assiut University
Patients with suspected airway illness often go through a diagnostic assessment that includes chest radiographs, Computed tomography scans, and fiber optic bronchoscopy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
Critical ill children with airway diseases
Procedure: Bronchscopy
Bronchscopy in critical ill children with airway diseases
Other Names:
  • chest computed tomography scan with virtual bronchscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visualization of airway abnormalities by bronchscopy
Time Frame: During procedure
Direct visualization of airway by bronchscopy
During procedure
Visualization of airway abnormalities by computed tomography scan
Time Frame: During procedure
Assessment of airway by computed tomography scan with virtual bronchscopy
During procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

July 19, 2024

First Submitted That Met QC Criteria

July 24, 2024

First Posted (Actual)

July 30, 2024

Study Record Updates

Last Update Posted (Actual)

July 30, 2024

Last Update Submitted That Met QC Criteria

July 24, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BVIAD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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