Foreign Body AspirationNCT07150689
Outcome of Bronchoscopy in FB Aspiration
A study testing Rigid bronchoscopy, Flexible scope and Combined Flexible-Rigid Bronchoscopy in people with Foreign Body Aspiration, run by Assiut University.
Trial summary
Outcome of Bronchoscopy in Pediatric patient with foreign body aspiration Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Foreign Body Aspiration
- What is being tested?
- Rigid bronchoscopy, Flexible scope and Combined Flexible-Rigid Bronchoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children less than 18 years with suspected foreign body aspiration
Who cannot join
- children with congenital airway anomalies other than foreign body aspiration
About this study
Official title: Assessment of Outcome of Bronchoscopy in Pediatric Patients With Suspected Foreign Body Aspiration Attending at Assiut University Children Hospital
Outcome of Bronchoscopy in Pediatric patient with foreign body aspiration
- Conditions
- Foreign Body Aspiration
- Being tested
- Rigid bronchoscopy, Flexible scope, Combined Flexible-Rigid Bronchoscopy, Imaging-Guided Bronchoscopy
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rigid bronchoscopyProcedure or surgery
Participants will undergo rigid bronchoscopy under general anesthesia using an age-appropriate rigid bronchoscope. The airway will be systematically inspected. Any identified foreign body will be removed using appropriate retrieval devices (optical forceps, retrieval basket, suction). Post-removal, the airway will be re-examined to confirm clearance and detect trauma.
Flexible scopeProcedure or surgery
Participants will undergo flexible fiberoptic bronchoscopy under sedation or general anesthesia. The bronchoscope will be inserted transorally or transnasally. The airway will be inspected, and foreign body retrieval attempted using retrieval baskets, forceps, or cryoprobe
Combined Flexible-Rigid BronchoscopyProcedure or surgery
Initial flexible bronchoscopy will be performed to locate the foreign body and inspect distal airways, followed by rigid bronchoscopy for definitive removal.
Imaging-Guided BronchoscopyProcedure or surgery
Participants will undergo pre-procedure high-resolution CT or virtual bronchoscopy. Based on imaging, either rigid or flexible bronchoscopy will be performed, targeting the suspected location to reduce procedure time.
| Study group | Role | What they receive |
|---|---|---|
| Rigid Bronchoscopy | Active comparator | Standard of care in most pediatric centers; performed under general anesthesia to visualize and remove FB. Gold standard for both diagnosis and treatment Receives: Procedure: Rigid bronchoscopy |
| Flexible Bronchoscop | Experimental | Flexible scope used for diagnosis and sometimes removal (especially in distal airways or when FB is small). Evaluate if less invasive flexible bronchoscopy can be effective. Receives: Procedure: Flexible scope |
| Combined Approach | Experimental | Initial flexible bronchoscopy for diagnosis and airway inspection, followed by rigid bronchoscopy for removal if needed. Compare efficiency and safety of combined method. Receives: Procedure: Combined Flexible-Rigid Bronchoscopy |
| Imaging-Guided Approach | Experimental | High-resolution CT or virtual bronchoscopy first; bronchoscopy only if imaging suggests FB. Assess if imaging can reduce unnecessary bronchoscopies. Receives: Procedure: Imaging-Guided Bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Successful Foreign Body Removal
The proportion of patients in whom the foreign body is completely removed during the initial bronchoscopy procedure, as confirmed by direct visualization and/or post-procedure imaging.
Measured: During bronchoscopy procedure (intra-operative, within 24 hours of intervention).
Secondary outcomes (1)
Incidence of procedure-related complications (within 24 hours).
Number of patients who experience complications such as hypoxia (SpO₂ < 90%), bleeding, airway trauma, pneumothorax, or cardiac arrhythmia.
Measured: Intra-procedure and up to 24 hours post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study startOct 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foreign Body AspirationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marsail Refat Kadry, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150689
- Sponsor's protocol ID
- FB bronchoscopy
- Status last verified
- Jul 2025
- First submitted
- 8 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Outcome of Bronchoscopy in Pediatric Patients With Suspected Foreign Body Aspiration Attending at Assiut University Children Hospital
- ClinicalTrials.gov ID
- NCT07150689
- Acronym / sponsor ID
- FB bronchoscopy
- Conditions
- Foreign Body Aspiration
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 2 Sep 2025 (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.
Outcome of Bronchoscopy in Pediatric patient with foreign body aspiration
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Rigid Bronchoscopy | Active comparator | Procedure: Rigid bronchoscopyStandard of care in most pediatric centers; performed under general anesthesia to visualize and remove FB. Gold standard for both diagnosis and treatment |
| Flexible Bronchoscop | Experimental | Procedure: Flexible scopeFlexible scope used for diagnosis and sometimes removal (especially in distal airways or when FB is small). Evaluate if less invasive flexible bronchoscopy can be effective. |
| Combined Approach | Experimental | Procedure: Combined Flexible-Rigid BronchoscopyInitial flexible bronchoscopy for diagnosis and airway inspection, followed by rigid bronchoscopy for removal if needed. Compare efficiency and safety of combined method. |
| Imaging-Guided Approach | Experimental | Procedure: Imaging-Guided BronchoscopyHigh-resolution CT or virtual bronchoscopy first; bronchoscopy only if imaging suggests FB. Assess if imaging can reduce unnecessary bronchoscopies. |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- children less than 18 years with suspected foreign body aspiration
Key exclusion criteria (1 listed)
- children with congenital airway anomalies other than foreign body aspiration
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 |
|---|---|---|
| Rigid bronchoscopyParticipants will undergo rigid bronchoscopy under general anesthesia using an age-appropriate rigid bronchoscope. The airway will be systematically inspected. Any identified foreign body will be removed using appropriate retrieval devices (optical forceps, retrieval basket, suction). Post-removal, the airway will be re-examined to confirm clearance and detect trauma. | Procedure or surgery | Rigid Bronchoscopy |
| Flexible scopeParticipants will undergo flexible fiberoptic bronchoscopy under sedation or general anesthesia. The bronchoscope will be inserted transorally or transnasally. The airway will be inspected, and foreign body retrieval attempted using retrieval baskets, forceps, or cryoprobe | Procedure or surgery | Flexible Bronchoscop |
| Combined Flexible-Rigid BronchoscopyInitial flexible bronchoscopy will be performed to locate the foreign body and inspect distal airways, followed by rigid bronchoscopy for definitive removal. | Procedure or surgery | Combined Approach |
| Imaging-Guided BronchoscopyParticipants will undergo pre-procedure high-resolution CT or virtual bronchoscopy. Based on imaging, either rigid or flexible bronchoscopy will be performed, targeting the suspected location to reduce procedure time. | Procedure or surgery | Imaging-Guided Approach |
Primary outcome
Rate of Successful Foreign Body Removal
Time frame: During bronchoscopy procedure (intra-operative, within 24 hours of intervention).
The proportion of patients in whom the foreign body is completely removed during the initial bronchoscopy procedure, as confirmed by direct visualization and/or post-procedure imaging.
1 secondary outcome
Incidence of procedure-related complications (within 24 hours).
Time frame: Intra-procedure and up to 24 hours post-procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Rigid bronchoscopy, Flexible scope and Combined Flexible-Rigid Bronchoscopy in people with Foreign Body Aspiration, 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 2 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Successful Foreign Body Removal (time frame: During bronchoscopy procedure (intra-operative, within 24 hours of intervention).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2025.