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Status unknownNCT04467307Updated Jul 13, 2020

Comparison of Patients With and Without Foreign Body Aspiration After Bronchoscopy.

An interventional study of Rigit bronchoscopy in Foreign Body Aspiration, Blood Gas, Bronchoscopy, sponsored by Kahramanmaras Sutcu Imam University. Status unknown at 1 site in Turkey. Open to participants aged Up to 6 Years. Per ClinicalTrials.gov, last updated 2020-07-13.

Sponsored by Kahramanmaras Sutcu Imam University · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Non-randomized
Ages
Up to 6 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Foreign Body Aspiration, Blood Gas, Bronchoscopy
03

Who can participate

Ages eligible
Up to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Suspected foreign body aspiration

Exclusion criteria

Exclusion Criteria:

infection, trauma

04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • 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.

    Device: Rigit bronchoscopy

  • 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.

    Device: Rigit bronchoscopy

Interventions

  • DeviceRigit 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.

05

What researchers measure

Primary outcomes

  1. Foreign body aspiration

    The presence of a foreign body in the airway by bronchoscopy, radiological findings, blood gas

    Time frame: 1 week

06

Study locations

1 of 1 sites recruiting
  • Kahramanmaras Sutcu Imam University
    Kahramanmaras, Onikisubat 46050, Turkey
    Recruiting
07

Registry details

Key details

Study ID
NCT04467307
Lead sponsor
Kahramanmaras Sutcu Imam University
Responsible party
Ahmet Gökhan Güler (Department of pediatric surgery, Kahramanmaras Sutcu Imam University) — Principal investigator
First posted
Jul 13, 2020
Start date
Feb 1, 2020
Primary completion
Jun 1, 2021 (estimated)
Completion
Oct 1, 2021 (estimated)
Last update
Jul 13, 2020

Study contacts

ahmet gokhan güler
Contact
drgokhanguler@gmail.com
+905057702633
mustafa sabih kaya
Contact
sabihkaya@gmail.com
+905316828311

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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