- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04467307
Comparison of Patients With and Without Foreign Body Aspiration After Bronchoscopy.
July 8, 2020 updated by: Ahmet Gökhan Güler, Kahramanmaras Sutcu Imam University
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.
Study Overview
Status
Unknown
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: mustafa sabih kaya
- Phone Number: +905316828311
- Email: sabihkaya@gmail.com
Study Locations
-
-
Onikisubat
-
Kahramanmaras, Onikisubat, Turkey, 46050
- Recruiting
- Kahramanmaras Sutcu Imam University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 6 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Suspected foreign body aspiration
Exclusion Criteria:
infection, trauma
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Foreign body aspiration.
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.
|
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.
|
Active Comparator: Group with no foreign body aspiration
Patients undergoing bronchoscopy with suspicion of foreign body aspiration, but there is no foreign body in bronchoscopy.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Foreign body aspiration
Time Frame: 1 week
|
The presence of a foreign body in the airway by bronchoscopy, radiological findings, blood gas
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2020
Primary Completion (Anticipated)
June 1, 2021
Study Completion (Anticipated)
October 1, 2021
Study Registration Dates
First Submitted
July 8, 2020
First Submitted That Met QC Criteria
July 8, 2020
First Posted (Actual)
July 13, 2020
Study Record Updates
Last Update Posted (Actual)
July 13, 2020
Last Update Submitted That Met QC Criteria
July 8, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020/02-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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