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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laryngotracheal Aspiration Procedure Using a Probe in the Emergency Department | Patients with aspiration pneumonia. 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. |
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| Aspiration Using Fibrobronchoscopy in the Emergency Department | Patients with aspiration pneumonia. 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laryngotracheal Aspiration Procedure Using a Probe in the Emergency Department | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay in days | Length of hospital stay in days | up to 3 months |
| Mortality rate within 30 days from the time of admission to the Emergency Department | Mortality rate within 30 days from the time of admission to the Emergency Department | 30 days from admission to the ed |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory parameters before and after the procedure | (SpO2, FiO2)before and after the procedure | on the admission and 30 minutes after the procedure |
| Rate of patient treated with Non invase ventilation and with orotracheal intubation |
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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
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lorenzo Pelagatti, Dr | Contact | +393385917317 | pelagattil@aou-careggi.toscana.it | |
| Pelagatti Lorenzo, Dr | Contact | +390557947088 | lorenzo.pelagatti@unifi.it |
| Name | Affiliation | Role |
|---|---|---|
| Lorenzo Pelagatti, dr | University of Florence | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Careggi | Recruiting | Florence | Tuscany/Italy | 50122 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40483618 | Derived | 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. |
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| Aspiration Procedure Using Fibrobronchoscopy in the Emergency Department | Procedure | 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. |
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Oxygen therapy devices before and after the procedure
| on the admission and 30 minutes after the procedure |
| Rate of admission in Intensive care unit and High dependency unit | Hospitalization setting | immediately after the procedure |
| Procedure-related complications | Procedure-related complications | perioperatively/periprocedurally |
| ID | Term |
|---|---|
| D011015 | Pneumonia, Aspiration |
| D012131 | Respiratory Insufficiency |
| D011014 | Pneumonia |
| D018410 | Pneumonia, Bacterial |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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