NCT06106503

Brief Summary

Airway foreign body is one of the common emergencies. Its clinical presentation is variable, ranging from a clinically asymptomatic state to dire state of respiratory failure needing urgent attention and intervention. The gold standard for management is rigid bronchoscopy (RB) under general anaesthesia. Complications that can occur during removal of foreign body include bleeding, pneumothorax and rupture of tracheobronchial tree. Complication rates are higher during foreign body removal in children. Performance of routine post bronchoscopy chest radiography (CXR) results in an extremely low diagnostic yield but nevertheless is the common clinical practice prevailing today. It has previously been suggested that routine post bronchoscopy CXR could be avoided in asymptomatic patients.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Typical duration for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 30, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

December 15, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

December 5, 2023

Status Verified

December 1, 2023

Enrollment Period

2 years

First QC Date

October 24, 2023

Last Update Submit

December 2, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • chest x-ray post bronchoscopy.

    chest x-ray post bronchoscopy is not necessary unless there are signs or symptoms.

    2 years

Study Arms (2)

patients will not underwent chest x-ray

OTHER
Other: clinical examination

patients underwent chest x-ray

OTHER

patients underwent chest x-ray

Radiation: chest x-ray

Interventions

chest x-rayRADIATION

chest x-ray after rigid bronchoscopy for patient with foreign body inhalation

patients underwent chest x-ray

no investigations well be done unless needed

patients will not underwent chest x-ray

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients with strong clinical suspicion of foreign body in airway with a history of choking, cyanosis, difficulty in breathing.

You may not qualify if:

  • Patients underwent esophagoscope.
  • Patients refused to be enrolled in research.
  • Patients suffering from evident complications during the procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

X-RaysRestraint, Physical

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, IonizingBehavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Mohamed ayaad, professor

    Director

    STUDY DIRECTOR

Central Study Contacts

Mohamed boudy, resident

CONTACT

Hussein Alkhayat, ass. professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

October 24, 2023

First Posted

October 30, 2023

Study Start

December 15, 2023

Primary Completion

December 15, 2025

Study Completion

December 30, 2025

Last Updated

December 5, 2023

Record last verified: 2023-12