NCT06511583

FBS-ASaP: Fibrobronchoscopy in ASpiration Pneumonia in the Emergency Department

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Azienda Ospedaliero-Universitaria Careggi · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Non-Profit Prospective Observational Pilot Study The study will have an overall duration of 3 years, with patient enrollment starting after ethical committee approval. In this study, all patients with a diagnosis of aspiration pneumonia who require aspiration of secretions or ingesta in the Emergency Department will be considered. A registry will be created with the patients\' data, noting the type of procedure performed: laryngotracheal aspiration with a probe or with fibrobronchoscopy. This observational registry pilot study aims to evaluate the utility and adverse events related to the use of aspiration via videobronchoscopy performed in the Emergency Department and to compare the clinical outcomes of patients undergoing bronchoscopy with those treated only with blind laryngotracheal aspiration using a probe.

Conditions

• Aspiration Pneumonia
• Bronchoscopy

Interventions

Type	Name	Description
PROCEDURE	Laryngotracheal Aspiration Procedure Using a Probe in the Emergency Department	For laryngotracheal aspiration using a blind probe, the patient will be positioned in a seated or semi-seated position; if this is not possible, the aspiration will be performed in a supine position. A soft, sterile catheter connected to the suction apparatus will be inserted into one nostril while keeping the patient\'s head tilted back. When the tip of the catheter reaches the back of the pharynx, the patient will need to breathe to facilitate the insertion and allow the catheter to advance into the larynx and trachea. At this point, using negative suction pressure for a maximum of 3-5 seconds, the secretions will be aspirated. The aspiration will be repeated multiple times in cycles of 3-5 seconds.
PROCEDURE	Aspiration Procedure Using Fibrobronchoscopy in the Emergency Department	Equipment Setup: A sterile bronchoscope will be connected to the suction apparatus. Procedure: The bronchoscope will be gently inserted through the patient\'s nostril or mouth, advancing carefully through the pharynx and larynx into the trachea and bronchi. The physician will visually inspect the airways through the bronchoscope. Using the bronchoscope's suction channel, secretions will be aspirated from the trachea and bronchi. Suctioning will be performed intermittently to avoid hypoxia, with each suctioning cycle lasting no more than 3-5 seconds. The procedure may be repeated as necessary to ensure thorough aspiration of secretions.

Timeline

• Start date: 2024-02-05
• Primary completion: 2027-02-05
• Completion: 2027-03-05
• First posted: 2024-07-22
• Last updated: 2024-07-22

Locations

1 site across 1 country: Italy