NCT07150689

Brief Summary

Outcome of Bronchoscopy in Pediatric patient with foreign body aspiration

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Oct 2025

Status
not yet recruiting

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

Study Progress60%
Oct 2025Oct 2026

First Submitted

Initial submission to the registry

August 8, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

September 2, 2025

Completed
29 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

September 2, 2025

Status Verified

July 1, 2025

Enrollment Period

1 year

First QC Date

August 8, 2025

Last Update Submit

August 28, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    During bronchoscopy procedure (intra-operative, within 24 hours of intervention).

Secondary Outcomes (1)

  • Incidence of procedure-related complications (within 24 hours).

    Intra-procedure and up to 24 hours post-procedure.

Study Arms (4)

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

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.

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.

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.

Procedure: Imaging-Guided Bronchoscopy

Interventions

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.

Rigid Bronchoscopy

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

Flexible Bronchoscop

Initial flexible bronchoscopy will be performed to locate the foreign body and inspect distal airways, followed by rigid bronchoscopy for definitive removal.

Combined Approach

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.

Imaging-Guided Approach

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • children less than 18 years with suspected foreign body aspiration

You may not qualify if:

  • children with congenital airway anomalies other than foreign body aspiration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Masking Description
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

August 8, 2025

First Posted

September 2, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

September 2, 2025

Record last verified: 2025-07