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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04467307
Other study ID # 2020/02-02
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2020
Est. completion date October 1, 2021

Study information

Verified date July 2020
Source Kahramanmaras Sutcu Imam University
Contact ahmet gokhan güler
Phone +905057702633
Email drgokhanguler@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date October 1, 2021
Est. primary completion date June 1, 2021
Accepts healthy volunteers No
Gender All
Age group N/A to 6 Years
Eligibility Inclusion Criteria:

Suspected foreign body aspiration

Exclusion Criteria:

infection, trauma

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Rigit 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.

Locations

Country Name City State
Turkey Kahramanmaras Sutcu Imam University Kahramanmaras Onikisubat

Sponsors (1)

Lead Sponsor Collaborator
Kahramanmaras Sutcu Imam University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Foreign body aspiration The presence of a foreign body in the airway by bronchoscopy, radiological findings, blood gas 1 week