Foreign Body AspirationNCT06106503
Routine Chest X-ray Post Rigid Bronchoscopy for Foreign Body Extraction: is it Necessary?
A study testing chest x-ray and clinical examination in people with Foreign Body Aspiration, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Foreign Body Aspiration
- What is being tested?
- chest x-ray and clinical examination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2023to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients underwent esophagoscope.
- Patients refused to be enrolled in research.
- Patients suffering from evident complications during the procedure.
Trial locations and contacts
No sites are listed yet.
About this study
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:
- History taking including if there was a definite history of foreign body inhalation or not.
- 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.
- 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.
- Conditions
- Foreign Body Aspiration
- Being tested
- chest x-ray, clinical examination
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chest x-rayRadiation
chest x-ray after rigid bronchoscopy for patient with foreign body inhalation
clinical examinationOther
no investigations well be done unless needed
| Study group | Role | What they receive |
|---|---|---|
| patients will not underwent chest x-ray | Other | Not described Receives: Other: clinical examination |
| patients underwent chest x-ray | Other | patients underwent chest x-ray Receives: Radiation: chest x-ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
chest x-ray post bronchoscopy.
chest x-ray post bronchoscopy is not necessary unless there are signs or symptoms.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start15 Dec 2023 (estimated)
- Primary completion15 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foreign Body AspirationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mostafa Ibrahim Abdelrahman Boudy, Assiut University
- Investigators
- Mohamed ayaad, professor, Study director, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106503
- Sponsor's protocol ID
- chest xray post bronchoscopy
- Status last verified
- Dec 2023
- First submitted
- 24 Oct 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Chest X-ray Post Rigid Bronchoscopy for Foreign Body Extraction: is it Necessary?
- ClinicalTrials.gov ID
- NCT06106503
- Acronym / sponsor ID
- chest xray post bronchoscopy
- Conditions
- Foreign Body Aspiration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Dec 2023 (estimated)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Pre-operative assessment:
- History taking including if there was a definite history of foreign body inhalation or not.
- 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.
- 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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients will not underwent chest x-ray | Other | Other: clinical examination |
| patients underwent chest x-ray | Other | Radiation: chest x-raypatients underwent chest x-ray |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients underwent esophagoscope.
- Patients refused to be enrolled in research.
- Patients suffering from evident complications during the procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chest x-raychest x-ray after rigid bronchoscopy for patient with foreign body inhalation | Radiation | patients underwent chest x-ray |
| clinical examinationno investigations well be done unless needed | Other | patients will not underwent chest x-ray |
Primary outcome
chest x-ray post bronchoscopy.
Time frame: 2 years
chest x-ray post bronchoscopy is not necessary unless there are signs or symptoms.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed ayaad, professor study director
Director
Questions about this trial
What is this clinical trial studying?
A study testing chest x-ray and clinical examination in people with Foreign Body Aspiration, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed boudy, resident (02001003658357, mohamedmostafa614@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
chest x-ray post bronchoscopy. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.