Clinical trial NCT06511583: FBS-ASaP: Fibrobronchoscopy in ASpiration Pneumonia in the Emergency Department
Official title: FBS-ASaP: Fibrobronchoscopy in ASpiration Pneumonia in the Emergency Department
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aspiration Pneumonia
Bronchoscopy
Keywords: Aspiration pneumonia
Bronchoscopy
toilette
interventional pulmunology
respiratory failure
pneumonia
bacterial pneumonia
Lead sponsor: Azienda Ospedaliero-Universitaria Careggi
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be conducted on patients with a diagnosis of aspiration pneumonia who, based on the judgment of the attending physician, require aspiration of secretions or ingesta in the emergency department using a probe and/or a fiberscope. Enrollment in the study will be determined by the Emergency Department physician in charge of the patient.

Estimated number of patients to be enrolled: 100.

Brief 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\&#39; 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 criteria: 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 \&amp;lt; 18 years
* Pregnancy
* Hemorrhagic diathesis
* Malignant cardiac arrhythmias (VT, AV block excluding first-degree AV block)
* Severe airway obstruction

Primary outcomes:
measure: Length of hospital stay in days
timeFrame: up to 3 months
measure: Mortality rate within 30 days from the time of admission to the Emergency Department
timeFrame: 30 days from admission to the ed
Secondary outcomes:
measure: Respiratory parameters before and after the procedure
timeFrame: on the admission and 30 minutes after the procedure
measure: Rate of patient treated with Non invase ventilation and with orotracheal intubation
timeFrame: on the admission and 30 minutes after the procedure
measure: Rate of admission in Intensive care unit and High dependency unit
timeFrame: immediately after the procedure
measure: Procedure-related complications
timeFrame: perioperatively/periprocedurally
Other outcomes:
Locations:
city: Florence
country: Italy
facility: AOU Careggi
state: Tuscany/Italy
Study officials:
affiliation: University of Florence
name: Lorenzo Pelagatti, dr
role: PRINCIPAL_INVESTIGATOR
References: