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Clinical Trials in Italy / NCT06511583
Recruiting Observational

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

NCT06511583 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2024-02-05
Last updated
2024-07-22

Condition(s) studied

Aspiration PneumoniaBronchoscopy

Investigational drug(s) / intervention(s)

Laryngotracheal Aspiration Procedure Using a Probe in the Emergency DepartmentAspiration Procedure Using Fibrobronchoscopy in the Emergency Department

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: All adult patients who access the Emergency Department with a diagnosis of aspiration pneumonia and for whom the referring physician determines the need for aspiration of secretions or ingesta. Patients must have at least one of the following criteria * Radiological evidence of pneumonia (Chest X-ray/CT scan/Chest ultrasound) * Clinical diagnosis of aspiration pneumonia * Presence of secretions in the upper airways * Respiratory distress in a dysphagic patient * Need for oxygen therapy or need to increase FiO2 in patients already on home oxygen therapy Exclusion Criteria: * Lack of consent * Age \< 18 years * Pregnancy * Hemorrhagic diathesis * Malignant cardiac arrhythmias (VT, AV block excluding first-degree AV block) * Severe airway obstruction

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
AOU Careggi Florence Tuscany/Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06511583 on ClinicalTrials.gov ↗ ← All trials in Italy