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Not yet recruitingNCT06106503Updated Dec 5, 2023

Routine Chest X-ray Post Rigid Bronchoscopy for Foreign Body Extraction: is it Necessary?

An interventional study of chest x-ray and clinical examination in Foreign Body Aspiration, sponsored by Assiut University. Not yet recruiting. Per ClinicalTrials.gov, last updated 2023-12-05.

Sponsored by Assiut University · Not applicable, Interventional, and Screening

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Sex
All
01

Study 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.

Read the detailed description
  • Pre-operative assessment:

    1. History taking including if there was a definite history of foreign body inhalation or not.
    2. Clinical examination including symptomatology (such as the presence or absence of choking, cyanosis, and difficulty in breathing) and Clinical signs, such as the presence or absence of air entry, crept, and rhonchi.
    3. Radiological signs, such as plain chest X-ray findings.
  • operation: all patients underwent rigid bronchoscopy under general anesthesia. We used bronchoscopes of the rigid type to perform bronchoscopy. We determined the size of the bronchoscope according to the child's age. After induction of intravenous anesthesia, we performed direct laryngoscopy and inserted the bronchoscope with the help of the laryngoscope in a rotating manner and used a 0-degree telescope to locate the foreign body. Once identified, we used optical forceps to hold and to remove the foreign body. After extraction of the foreign body, we repeated bronchoscopy to check for any remaining foreign bodies as well as to examine the tracheobronchial tree for any trauma.
  • Post-operative assessment:

All patients will be under observation for at least an hour after the procedure.

All patients will receive ATROVENT and PULMICORT after the procedure through a nebulizer.

All patients will be examined clinically and vital signs will be assessed be before discharge CXR will be done only if there are critical signs as cyanosis, absent or decreased air entery on one side or both or surgical emphysema Strict instructions, that if any symptoms such as cyanosis or difficulty of breathing occur, to go the nearest health care provider.

02

Conditions studied

  • Foreign Body Aspiration

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03

In context

Respiratory Aspiration

25 studies on the registry are indexed under Respiratory Aspiration; 6 are open to participants now.

This study's planned enrollment of 100 is above the median of 66 across 18 interventional studies indexed under Respiratory Aspiration.

Browse Respiratory Aspiration studies →

Lead sponsor

Assiut University is the lead sponsor of 5,079 studies on the registry; 2,177 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All patients with strong clinical suspicion of foreign body in airway with a history of choking, cyanosis, difficulty in breathing.
  • All patients with strong clinical suspicion of foreign body in airway with the presence of clinical signs, like decreased air entry, cyanosis, or crept. Patients of any age and sex who qualified for the inclusion criteria were included.

Exclusion criteria

Exclusion Criteria:

  • Patients underwent esophagoscope.
  • Patients refused to be enrolled in research.
  • Patients suffering from evident complications during the procedure.
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    patients will not underwent chest x-ray

    Other: clinical examination

  • Other
    patients underwent chest x-ray

    patients underwent chest x-ray

    Radiation: chest x-ray

Interventions

  • Radiationchest x-ray

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

  • Otherclinical examination

    no investigations well be done unless needed

06

What researchers measure

Primary outcomes

  1. chest x-ray post bronchoscopy.

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

    Time frame: 2 years

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2023; primary completion for Dec 2025, 24 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 24, 2023
First posted
Oct 30, 2023
StartEst.
Dec 15, 2023
Primary completionEst.
Dec 15, 2025
CompletionEst.
Dec 30, 2025
Last update
Dec 5, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06106503
Lead sponsor
Assiut University
Responsible party
Mohamed Mostafa Ibrahim Abdelrahman Boudy (Doctor, Assiut University) — Principal investigator
First posted
Oct 30, 2023
Start date
Dec 15, 2023 (estimated)
Primary completion
Dec 15, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Dec 5, 2023

Study contacts

Mohamed boudy, resident
Contact
mohamedmostafa614@gmail.com
02001003658357
Hussein Alkhayat, ass. professor
Contact
dr_khayat@hotmail.com
01005549653
Mohamed ayaad, professor
study director · Director

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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