Chest DisorderNCT07043309
Study the Diagnostic and Therapeutic Role of Flexible Bronchoscopy in the Patients Attending Assuit University Children Hospita
An observational study of Chest Disorder, run by Assiut University.
Trial summary
Bronchoscopyhasbeenutilizedinchildrenforlongforthediagnosisofairwayabnormalitiesand obtainingbronchoalveolarlavage.Thoughtherehasbeenrapidgrowthofbronchoscopic interventionsinadultpatients,useinchildrenhasbeenlimited.Newerbronchoscopictechnologies… Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Chest Disorder
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 1 Aug 2026
- Phase
- Observational
- 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 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All children in pediatric bronchoscopy unit
Who may be able to join
- Age group of children ≥1≤18 years
- All children in pediatric bronchoscopy unit
- Both sex
- Children first guardians accepted to participate in the current study
Who cannot join
- age less than1year or more than 18 years
- Children first guardians refused to participate in the current study
About this study
Bronchoscopyhasbeenutilizedinchildrenforlongforthediagnosisofairwayabnormalitiesand obtainingbronchoalveolarlavage.Thoughtherehasbeenrapidgrowthofbronchoscopic interventionsinadultpatients,useinchildrenhasbeenlimited.Newerbronchoscopictechnologies andinstrumentsarefocussedlargelyonadultpatients.Riskofsedationandsmallairwaysizealso havebeenlimitingfactors.Butrecentadvancesinequipmentsintheformofhinnerbronchoscopes withworkingchannelsandthinnerinstrumentshavefacilitatedbronchoscopicinterventionsin children.(1) Pediatricflexiblelaryngotrachealbronchoscopy(FB)isahighlyversatileandeffectivediagnostic andtherapeutictoolwithanimportantroleinpediatricrespiratorymedicine. Itwasfirstdescribedin 1968andappliedinthepediatricpopulation10yearslater.(2,3,4) Nowadays,FBisanintegralpartofthemaagementofneonates, infants,andchildrenwithvarious lungandairwaydiseases. InternationalrecommendationsonpediatricFBhavebeenpublishedby theEuropeanRespiratorySociety(ERS)andtheAmericanThoracicSocietyanddescribethe indications,thefacilities,andequipmentneededfortheprocedure,careoftheinstrumentsinvolved, techniques,andsuggestionsforsedationandpatientmanagement.(5-7) FBcanbeperformedfordiagnosticand/ortherapeuticpurposes.Itenablesanassessmentofthe airway'sanatomicalfeaturesandthecollectionofsamplesfromthedistalairways(bronchoalveolar lavage[BAL],bronchialbrushing,bronchialbiopsy)forpathologicalandmicrobiological examination.IndicationsfordiagnosticFB includestridor,persistent/re-currentwheezing,chronic cough(productiveorotherwise),recurrentpneumonia,suspectedforeignbodyaspiration, hemoptysisandpulmonaryhemorrhage,suspectedstructuralanomaliesorendobronchial lesions, radiographicabnormalities(atelectasis,recurrent/persistentconsolidations,atypicalandunknown infiltrates, localizedhyperinflation),monitoringoflungallograftorartificialairway,andobstructive sleepapnea)6,7). IndicationsfortherapeuticFB includerestoringairwaypatencyincasesofmucusplugsorblood clots,treatingalveolarfillingdisorders(alveolarproteinosisandlipidpneumonia),controlling hemorrhage,dilatingastenoticairway,andbronchoscopicintubation.(7) Theneedforgeneralanaesthesiainthesepatientsincreasestheproblemsofairwaybecauseof theneedtoshareanalreadycompromisedairwaywiththeendoscopist.Asimpleandsafemethod isdescribed.Generalanaesthesiaisinducedeitherbyintravenousorinhalationtechnique The childbreathesspontaneouslyviaamaskwithahighinspiredoxygenconcentrationandhalothane
a$thecordsaresprayedwithlignocaine.TheBodaisuction-safeswivel-Yconnector(Sontek MedicalInc.CatalogNo:SMI-1002)isaversatileplasticadapterwithstandard15mmfittingswhich sitswellbetweentheRendellBaker-SoucekmaskandtheAyre'sT-piece.(8,9) toevaluatetheindications\&thefindingandtheadverseeventsofflexiblebronchoscopyat pediatric bronchoscopyunitatassuituniversitychildrenhospital
- Conditions
- Chest Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| study group | All children in pediatric bronchoscopy unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
the adverse events of flexible bronchoscopy
Severedesaturation(SaO2<80%)duringbronchoscopy
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest DisorderStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayat Gamal Darwish, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043309
- Sponsor's protocol ID
- diagm/therap bronchoscopy
- Status last verified
- Jun 2025
- First submitted
- 20 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study the Diagnostic and Therapeutic Role of Flexible Bronchoscopy in the Patients Attending Assuit University Children Hospita
- ClinicalTrials.gov ID
- NCT07043309
- Acronym / sponsor ID
- diagm/therap bronchoscopy
- Conditions
- Chest Disorder
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 29 Jun 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.
Bronchoscopyhasbeenutilizedinchildrenforlongforthediagnosisofairwayabnormalitiesand obtainingbronchoalveolarlavage.Thoughtherehasbeenrapidgrowthofbronchoscopic interventionsinadultpatients,useinchildrenhasbeenlimited.Newerbronchoscopictechnologies andinstrumentsarefocussedlargelyonadultpatients.Riskofsedationandsmallairwaysizealso havebeenlimitingfactors.Butrecentadvancesinequipmentsintheformofhinnerbronchoscopes withworkingchannelsandthinnerinstrumentshavefacilitatedbronchoscopicinterventionsin children.(1) Pediatricflexiblelaryngotrachealbronchoscopy(FB)isahighlyversatileandeffectivediagnostic andtherapeutictoolwithanimportantroleinpediatricrespiratorymedicine. Itwasfirstdescribedin 1968andappliedinthepediatricpopulation10yearslater.(2,3,4) Nowadays,FBisanintegralpartofthemaagementofneonates, infants,andchildrenwithvarious lungandairwaydiseases. InternationalrecommendationsonpediatricFBhavebeenpublishedby theEuropeanRespiratorySociety(ERS)andtheAmericanThoracicSocietyanddescribethe indications,thefacilities,andequipmentneededfortheprocedure,careoftheinstrumentsinvolved, techniques,andsuggestionsforsedationandpatientmanagement.(5-7) FBcanbeperformedfordiagnosticand/ortherapeuticpurposes.Itenablesanassessmentofthe airway'sanatomicalfeaturesandthecollectionofsamplesfromthedistalairways(bronchoalveolar lavage[BAL],bronchialbrushing,bronchialbiopsy)forpathologicalandmicrobiological examination.IndicationsfordiagnosticFB includestridor,persistent/re-currentwheezing,chronic cough(productiveorotherwise),recurrentpneumonia,suspectedforeignbodyaspiration, hemoptysisandpulmonaryhemorrhage,suspectedstructuralanomaliesorendobronchial lesions, radiographicabnormalities(atelectasis,recurrent/persistentconsolidations,atypicalandunknown infiltrates, localizedhyperinflation),monitoringoflungallograftorartificialairway,andobstructive sleepapnea)6,7). IndicationsfortherapeuticFB includerestoringairwaypatencyincasesofmucusplugsorblood clots,treatingalveolarfillingdisorders(alveolarproteinosisandlipidpneumonia),controlling hemorrhage,dilatingastenoticairway,andbronchoscopicintubation.(7) Theneedforgeneralanaesthesiainthesepatientsincreasestheproblemsofairwaybecauseof theneedtoshareanalreadycompromisedairwaywiththeendoscopist.Asimpleandsafemethod isdescribed.Generalanaesthesiaisinducedeitherbyintravenousorinhalationtechnique The childbreathesspontaneouslyviaamaskwithahighinspiredoxygenconcentrationandhalothane
a$thecordsaresprayedwithlignocaine.TheBodaisuction-safeswivel-Yconnector(Sontek MedicalInc.CatalogNo:SMI-1002)isaversatileplasticadapterwithstandard15mmfittingswhich sitswellbetweentheRendellBaker-SoucekmaskandtheAyre'sT-piece.(8,9) toevaluatetheindications\&thefindingandtheadverseeventsofflexiblebronchoscopyat pediatric bronchoscopyunitatassuituniversitychildrenhospital
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | –All children in pediatric bronchoscopy unit |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All children in pediatric bronchoscopy unit
Key inclusion criteria (4 listed)
- Age group of children ≥1≤18 years
Key exclusion criteria (2 listed)
- age less than1year or more than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the adverse events of flexible bronchoscopy
Time frame: baseline
Severedesaturation(SaO2<80%)duringbronchoscopy
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 29 Jun 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?
An observational study of Chest Disorder, 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 4 inclusion and 2 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 29 Jun 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?
the adverse events of flexible bronchoscopy (time frame: baseline). 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 29 Jun 2025.