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Recruiting NCT06511583

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

— Observational Aspiration Pneumonia Bronchoscopy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Laryngotracheal Aspiration Procedure Using a Probe in the Emergency Department, Aspiration Procedure Using Fibrobronchoscopy in the Emergency Department.
Who it may be relevant to
Registry conditions: Aspiration Pneumonia, Bronchoscopy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • 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 advanc
  • 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 hypox

Primary outcome measures

  • Length of hospital stay in days [Time frame: up to 3 months]
  • Mortality rate within 30 days from the time of admission to the Emergency Department [Time frame: 30 days from admission to the ed]
Secondary outcome measures (4)
  • Respiratory parameters before and after the procedure [Time frame: on the admission and 30 minutes after the procedure]
  • Rate of patient treated with Non invase ventilation and with orotracheal intubation [Time frame: on the admission and 30 minutes after the procedure]
  • Rate of admission in Intensive care unit and High dependency unit [Time frame: immediately after the procedure]
  • Procedure-related complications [Time frame: perioperatively/periprocedurally]

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 \< 18 years
  • Pregnancy
  • Hemorrhagic diathesis
  • Malignant cardiac arrhythmias (VT, AV block excluding first-degree AV block)
  • Severe airway obstruction

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Italy · 1 center
  • AOU Careggi — Florence

Publications

  • Pelagatti L, Montalbetti A, Viviani G, Ferretti A, Trigiani M, Corbetta L, Tomassetti S, Vanni S, Nazerian P. Fibrobronchoscopy versus laryngotracheal aspiration for bronchial toileting in patients with aspiration pneumonia in the emergency department. FBS-ASaP prospective case-control study. Intern Emerg Med. 2026 Apr;21(3):1077-1086. doi: 10.1007/s11739-025-04002-5. Epub 2025 Jun 8. PMID 40483618

Identifiers

NCT: NCT06511583 · CEAVC 22814

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗