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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06511583
Acronym
FBS-ASaP
Enrollment
100
Registered
2024-07-22
Start date
2024-02-05
Completion date
2027-03-05
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aspiration Pneumonia, Bronchoscopy

Keywords

Aspiration pneumonia, Bronchoscopy, toilette, interventional pulmunology, respiratory failure, pneumonia, bacterial pneumonia

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' 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.

Interventions

PROCEDURELaryngotracheal 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.

PROCEDUREAspiration 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.

Sponsors

Azienda Ospedaliero-Universitaria Careggi
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Length of hospital stay in daysup to 3 monthsLength of hospital stay in days
Mortality rate within 30 days from the time of admission to the Emergency Department30 days from admission to the edMortality rate within 30 days from the time of admission to the Emergency Department

Secondary

MeasureTime frameDescription
Respiratory parameters before and after the procedureon the admission and 30 minutes after the procedure(SpO2, FiO2)before and after the procedure
Rate of patient treated with Non invase ventilation and with orotracheal intubationon the admission and 30 minutes after the procedureOxygen therapy devices before and after the procedure
Rate of admission in Intensive care unit and High dependency unitimmediately after the procedureHospitalization setting
Procedure-related complicationsperioperatively/periprocedurallyProcedure-related complications

Countries

Italy

Contacts

Primary ContactLorenzo Pelagatti, Dr
pelagattil@aou-careggi.toscana.it+393385917317
Backup ContactPelagatti Lorenzo, Dr
lorenzo.pelagatti@unifi.it+390557947088

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026