NCT07043309

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
3mo left

Started Jul 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Jul 2025Aug 2026

First Submitted

Initial submission to the registry

June 20, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 29, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

1.1 years

First QC Date

June 20, 2025

Last Update Submit

June 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • the adverse events of flexible bronchoscopy

    Severedesaturation(SaO2\<80%)duringbronchoscopy

    baseline

Study Arms (1)

study group

All children in pediatric bronchoscopy unit

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

All children in pediatric bronchoscopy unit

You may qualify if:

  • 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

You may not qualify if:

  • age less than1year or more than 18 years
  • Children first guardians refused to participate in the current study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
residant doctor at Assiut university

Study Record Dates

First Submitted

June 20, 2025

First Posted

June 29, 2025

Study Start

July 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

June 29, 2025

Record last verified: 2025-06