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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06106503
Other study ID # chest xray post bronchoscopy
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 15, 2023
Est. completion date December 30, 2025

Study information

Verified date December 2023
Source Assiut University
Contact Mohamed boudy, resident
Phone 02001003658357
Email mohamedmostafa614@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Description:

- Pre-operative assessment: 1. History taking including if there was a definite history of foreign body inhalation or not. 2. 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. 3. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 30, 2025
Est. primary completion date December 15, 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - Patients underwent esophagoscope. - Patients refused to be enrolled in research. - Patients suffering from evident complications during the procedure.

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
chest x-ray
chest x-ray after rigid bronchoscopy for patient with foreign body inhalation
Other:
clinical examination
no investigations well be done unless needed

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary chest x-ray post bronchoscopy. chest x-ray post bronchoscopy is not necessary unless there are signs or symptoms. 2 years
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04279860 - Foreign Body Airway Obstruction, Incidence, Survival EMS-treatment and First Aid Treatment by Laypersons