Aspiration PneumoniaFBS-ASaPNCT06511583
FBS-ASaP: Fibrobronchoscopy in ASpiration Pneumonia in the Emergency Department
An observational study of Aspiration Pneumonia and Bronchoscopy, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aspiration Pneumonia, Bronchoscopy
- What is being tested?
- Laryngotracheal Aspiration Procedure Using a Probe in the Emergency Department and Aspiration Procedure Using Fibrobronchoscopy in the Emergency Department
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 5 Feb 2024to 5 Mar 2027
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Lack of consent
- Age \< 18 years
- Pregnancy
- Hemorrhagic diathesis
- Malignant cardiac arrhythmias (VT, AV block excluding first-degree AV block)
- Severe airway obstruction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
AOU Careggi
Florence, Tuscany/Italy, 50122
Pelagatti Lorenzo, Dr, +393385917317 ext. 00393385917317, pelagattil@aou-careggi.toscana.it
About this study
Non-Profit Prospective Observational Pilot Study
The study will have an overall duration of 3 years, with patient enrollment starting after ethical committee approval.
Read more
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.
- Conditions
- Aspiration Pneumonia, Bronchoscopy
- Being tested
- Laryngotracheal Aspiration Procedure Using a Probe in the Emergency Department, Aspiration Procedure Using Fibrobronchoscopy in the Emergency Department
- Keywords
- Aspiration pneumonia, Bronchoscopy, toilette, interventional pulmunology, respiratory failure, pneumonia, bacterial pneumonia
- Medical subject headings
- Pneumonia, Aspiration, Respiratory Insufficiency, Pneumonia, Pneumonia, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngotracheal Aspiration Procedure Using a Probe in the Emergency DepartmentProcedure or surgery
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 DepartmentProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Laryngotracheal Aspiration Procedure Using a Probe in the Emergency Department | |
| 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. Receives: Procedure: Aspiration Procedure Using Fibrobronchoscopy in the Emergency Department |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay in days
Length of hospital stay in days
Measured: 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
Measured: 30 days from admission to the ed
Secondary outcomes (4)
Respiratory parameters before and after the procedure
(SpO2, FiO2)before and after the procedure
Measured: on the admission and 30 minutes after the procedure
Rate of patient treated with Non invase ventilation and with orotracheal intubation
Oxygen therapy devices before and after the procedure
Measured: on the admission and 30 minutes after the procedure
Rate of admission in Intensive care unit and High dependency unit
Hospitalization setting
Measured: immediately after the procedure
Procedure-related complications
Procedure-related complications
Measured: perioperatively/periprocedurally
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start5 Feb 2024
- Primary completion5 Feb 2027 (estimated)
- Study completion5 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aspiration PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peiman Nazerian, Azienda Ospedaliero-Universitaria Careggi
- Investigators
- Lorenzo Pelagatti, dr, Principal investigator, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511583
- Sponsor's protocol ID
- CEAVC 22814
- Acronym
- FBS-ASaP
- Status last verified
- Jul 2024
- First submitted
- 10 Jul 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 40483618
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FBS-ASaP: Fibrobronchoscopy in ASpiration Pneumonia in the Emergency Department
- ClinicalTrials.gov ID
- NCT06511583
- Acronym / sponsor ID
- FBS-ASaP / CEAVC 22814
- Conditions
- Aspiration Pneumonia, Bronchoscopy
- Keywords
- Aspiration pneumonia, Bronchoscopy, toilette, interventional pulmunology, respiratory failure, pneumonia, bacterial pneumonia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria CareggiUniversity, hospital or other
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 5 Feb 2027 (estimated)
- Study completion
- 5 Mar 2027 (estimated)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laryngotracheal Aspiration Procedure Using a Probe in the Emergency Department | – | Procedure: Laryngotracheal Aspiration Procedure Using a Probe in the Emergency DepartmentPatients 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. |
| Aspiration Using Fibrobronchoscopy in the Emergency Department | – | Procedure: Aspiration Procedure Using Fibrobronchoscopy in the Emergency DepartmentPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- Lack of consent
- Age \< 18 years
- Pregnancy
- Hemorrhagic diathesis
- Malignant cardiac arrhythmias (VT, AV block excluding first-degree AV block)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laryngotracheal Aspiration Procedure Using a Probe in the Emergency DepartmentFor 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. | Procedure or surgery | Laryngotracheal Aspiration Procedure Using a Probe in the Emergency Department |
| Aspiration Procedure Using Fibrobronchoscopy in the Emergency DepartmentEquipment 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. | Procedure or surgery | Aspiration Using Fibrobronchoscopy in the Emergency Department |
Primary outcome
Length of hospital stay in days
Time frame: up to 3 months
Length of hospital stay in days
Mortality rate within 30 days from the time of admission to the Emergency Department
Time frame: 30 days from admission to the ed
Mortality rate within 30 days from the time of admission to the Emergency Department
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Derived from this study: PubMed 40483618Pelagatti 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lorenzo Pelagatti, dr principal investigator
University of Florence
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aspiration Pneumonia and Bronchoscopy, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lorenzo Pelagatti, Dr (+393385917317, pelagattil@aou-careggi.toscana.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay in days (time frame: up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06511583, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.