Foreign Body Aspiration, Blood Gas, BronchoscopyNCT04467307
Comparison of Patients With and Without Foreign Body Aspiration After Bronchoscopy.
A study testing Rigit bronchoscopy in people with Foreign Body Aspiration, Blood Gas, Bronchoscopy, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
To compare patients under 5 years of age with foreign body aspiration and without foreign body aspiration with radiological and blood gas results. Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Foreign Body Aspiration, Blood Gas, Bronchoscopy
- What is being tested?
- Rigit bronchoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2020to 1 Oct 2021
- 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 Up to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Suspected foreign body aspiration
Who cannot join
- infection, trauma
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kahramanmaras Sutcu Imam University
Kahramanmaraş, Onikisubat, 46050
ahmet gökhan güler, +905057702633, drgokhanguler@gmail.com
About this study
Official title: Comparison of Symptoms and Findings and Short-term Results After Bronchoscopy in Patients With and Without the Foreign Body in Children Under 5 Years Old Who Underwent Bronchoscopy With Suspicion of Foreign Body Aspiration. A Prospective Study.
To compare patients under 5 years of age with foreign body aspiration and without foreign body aspiration with radiological and blood gas results.
Read the detailed description
Foreign body aspiration in children is a serious cause of mortality and morbidity. It is a preventable and treatable disease. Difficulties in diagnosis arise in non-radiopaque foreign body aspirations. Recently, when there is a suspicious history, bronchoscopy is recommended. Bronchoscopy is used to both diagnose and treat foreign body aspiration. Bronchoscopy seems to continue to be performed in suspicious cases until a method to establish a definitive diagnosis of foreign body aspirations before the operation is invented. In our study, to compare patients under 5 years of age with foreign body aspiration and without foreign body aspiration with radiological and blood gas results.
- Being tested
- Rigit bronchoscopy
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rigit bronchoscopyDevice
After general anesthesia, the airway is checked with a rigid bronchoscope suitable for the age. If there is a foreign body, it is removed by forceps.
| Study group | Role | What they receive |
|---|---|---|
| Foreign body aspiration. | Active comparator | Patients undergoing bronchoscopy with suspicion of foreign body aspiration. There is a foreign body in the bronchoscopy performed on these patients and it is the treated group. Receives: Device: Rigit bronchoscopy |
| Group with no foreign body aspiration | Active comparator | Patients undergoing bronchoscopy with suspicion of foreign body aspiration, but there is no foreign body in bronchoscopy. Receives: Device: Rigit bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foreign body aspiration
The presence of a foreign body in the airway by bronchoscopy, radiological findings, blood gas
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start1 Feb 2020
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foreign Body Aspiration, Blood Gas, BronchoscopyStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Gökhan Güler, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467307
- Sponsor's protocol ID
- 2020/02-02
- Status last verified
- Jul 2020
- First submitted
- 8 Jul 2020
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Symptoms and Findings and Short-term Results After Bronchoscopy in Patients With and Without the Foreign Body in Children Under 5 Years Old Who Underwent Bronchoscopy With Suspicion of Foreign Body Aspiration. A Prospective Study.
- ClinicalTrials.gov ID
- NCT04467307
- Acronym / sponsor ID
- 2020/02-02
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 13 Jul 2020 (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.
To compare patients under 5 years of age with foreign body aspiration and without foreign body aspiration with radiological and blood gas results.
Detailed description
Foreign body aspiration in children is a serious cause of mortality and morbidity. It is a preventable and treatable disease. Difficulties in diagnosis arise in non-radiopaque foreign body aspirations. Recently, when there is a suspicious history, bronchoscopy is recommended. Bronchoscopy is used to both diagnose and treat foreign body aspiration. Bronchoscopy seems to continue to be performed in suspicious cases until a method to establish a definitive diagnosis of foreign body aspirations before the operation is invented. In our study, to compare patients under 5 years of age with foreign body aspiration and without foreign body aspiration with radiological and blood gas results.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Foreign body aspiration. | Active comparator | Device: Rigit bronchoscopyPatients undergoing bronchoscopy with suspicion of foreign body aspiration. There is a foreign body in the bronchoscopy performed on these patients and it is the treated group. |
| Group with no foreign body aspiration | Active comparator | Device: Rigit bronchoscopyPatients undergoing bronchoscopy with suspicion of foreign body aspiration, but there is no foreign body in bronchoscopy. |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Suspected foreign body aspiration
Key exclusion criteria (1 listed)
- infection, trauma
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 |
|---|---|---|
| Rigit bronchoscopyAfter general anesthesia, the airway is checked with a rigid bronchoscope suitable for the age. If there is a foreign body, it is removed by forceps. | Device | Foreign body aspiration., Group with no foreign body aspiration |
Primary outcome
Foreign body aspiration
Time frame: 1 week
The presence of a foreign body in the airway by bronchoscopy, radiological findings, blood gas
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rigit bronchoscopy in people with Foreign Body Aspiration, Blood Gas, Bronchoscopy, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 13 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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 ahmet gokhan güler (+905057702633, drgokhanguler@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foreign body aspiration (time frame: 1 week). 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 13 Jul 2020.