Airway DiseaseNCT06526780
Bronchoscopy Versus Imaging in Diagnosis of Airway Diseases in Critically Ill Children
A study testing Bronchscopy in people with Airway Disease, run by Assiut University.
Trial summary
Patients with suspected airway illness often go through a diagnostic assessment that includes chest radiographs, Computed tomography scans, and fiber optic bronchoscopy. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Airway Disease
- What is being tested?
- Bronchscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2024to May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Show all 9Show fewer
- Persistent and recurrent wheezes.
- Persistent and recurrent atelectasis.
- Unexplained hemoptysis
Who cannot join
- Age ( < 1month and > 18 years )
- Severe hypoxemia
- Hemodynamic instability
- Uncorrected bleeding diathesis
- Unresolved lung infection
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Airway Disease
- Being tested
- Bronchscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BronchscopyProcedure or surgery
Also called chest computed tomography scan with virtual bronchscopy
Bronchscopy in critical ill children with airway diseases
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Critical ill children with airway diseases Receives: Procedure: Bronchscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visualization of airway abnormalities by bronchscopy
Direct visualization of airway by bronchscopy
Measured: During procedure
Visualization of airway abnormalities by computed tomography scan
Assessment of airway by computed tomography scan with virtual bronchscopy
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study startNov 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Airway DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AA Nagy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526780
- Sponsor's protocol ID
- BVIAD
- Status last verified
- Jul 2024
- First submitted
- 19 Jul 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 14582925Sinha 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 24822151Wood RE. Evaluation of the upper airway in children. Curr Opin Pediatr. 2008 Jun;20(3):266-71. doi: 10.1097/MOP.0b013e3282ff631e.
PubMed 18475094Davidson 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 19009620Soong 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 21513991Levin 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 19606008Faro 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 25932763Schramm 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 34098560Rosenthal M. Bronchoscopy and infection. Paediatr Respir Rev. 2003 Jun;4(2):143-6. doi: 10.1016/s1526-0542(03)00025-3.
PubMed 12758052
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchoscopy Versus Imaging in Diagnosis of Airway Diseases in Critically Ill Children
- ClinicalTrials.gov ID
- NCT06526780
- Acronym / sponsor ID
- BVIAD
- Conditions
- Airway Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with suspected airway illness often go through a diagnostic assessment that includes chest radiographs, Computed tomography scans, and fiber optic bronchoscopy.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: BronchscopyCritical ill children with airway diseases |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (5 listed)
- Age ( < 1month and > 18 years )
- Severe hypoxemia
- Hemodynamic instability
- Uncorrected bleeding diathesis
- Unresolved lung infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BronchscopyAlso: chest computed tomography scan with virtual bronchscopyBronchscopy in critical ill children with airway diseases | Procedure or surgery | Study group |
Primary outcome
Visualization of airway abnormalities by bronchscopy
Time frame: During procedure
Direct visualization of airway by bronchscopy
Visualization of airway abnormalities by computed tomography scan
Time frame: During procedure
Assessment of airway by computed tomography scan with virtual bronchscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Background: PubMed 14582925Midulla 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.
- Results publication: PubMed 24822151Sinha 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.
- Results publication: PubMed 18475094Wood RE. Evaluation of the upper airway in children. Curr Opin Pediatr. 2008 Jun;20(3):266-71. doi: 10.1097/MOP.0b013e3282ff631e.
- Results publication: PubMed 19009620Davidson MG, Coutts J, Bell G. Flexible bronchoscopy in pediatric intensive care. Pediatr Pulmonol. 2008 Dec;43(12):1188-92. doi: 10.1002/ppul.20910.
- Results publication: PubMed 21513991Soong 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.
- Results publication: PubMed 19606008Levin 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.
- Results publication: PubMed 25932763Faro 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.
- Results publication: PubMed 34098560Schramm 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.
- Results publication: PubMed 12758052Rosenthal M. Bronchoscopy and infection. Paediatr Respir Rev. 2003 Jun;4(2):143-6. doi: 10.1016/s1526-0542(03)00025-3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchscopy in people with Airway Disease, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Azza Ah Eltayeb (201006863277, azeltayeb@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visualization of airway abnormalities by bronchscopy (time frame: During procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06526780, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.