Routine Chest X-ray Post Rigid Bronchoscopy for Foreign Body Extraction: is it Necessary?

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06106503
Collaborator
(none)
100
2
25

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: chest x-ray
  • Other: clinical examination
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Routine Chest X-ray Post Rigid Bronchoscopy for Foreign Body Extraction: is it Necessary?
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Other: patients will not underwent chest x-ray

Other: clinical examination
no investigations well be done unless needed

Other: patients underwent chest x-ray

patients underwent chest x-ray

Radiation: chest x-ray
chest x-ray after rigid bronchoscopy for patient with foreign body inhalation

Outcome Measures

Primary Outcome Measures

  1. chest x-ray post bronchoscopy. [2 years]

    chest x-ray post bronchoscopy is not necessary unless there are signs or symptoms.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Director: Mohamed ayaad, professor, Director

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohamed Mostafa Ibrahim Abdelrahman Boudy, Doctor, Assiut University
ClinicalTrials.gov Identifier:
NCT06106503
Other Study ID Numbers:
  • chest xray post bronchoscopy
First Posted:
Oct 30, 2023
Last Update Posted:
Oct 31, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 31, 2023