- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07043309
- Original Trial
Study the Diagnostic and Therapeutic Role of Flexible Bronchoscopy in the Patients Attending Assuit University Children Hospita
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 Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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
Exclusion Criteria:
age less than1year or more than 18 years
- Children first guardians refused to participate in the current study
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
study group
All children in pediatric bronchoscopy unit
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the adverse events of flexible bronchoscopy
Time Frame: baseline
|
Severedesaturation(SaO2<80%)duringbronchoscopy
|
baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- diagm/therap bronchoscopy
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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