Actively Recruiting
FBS-ASaP: Fibrobronchoscopy in Aspiration Pneumonia in the Emergency Department
Led by Azienda Ospedaliero-Universitaria Careggi ยท Updated on 2024-07-22
100
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This observational pilot study focuses on adult patients diagnosed with aspiration pneumonia who require aspiration of secretions or ingesta in the Emergency Department. The study aims to evaluate and compare the usefulness and adverse events of two aspiration methods: laryngotracheal aspiration with a probe and aspiration using fibrobronchoscopy. Researchers will create a registry to collect patient data and assess clinical outcomes related to these procedures. The study involves two main procedures. The first is laryngotracheal aspiration using a blind probe, where a soft catheter is inserted through the nostril to suction secretions from the larynx and trachea in cycles lasting 3-5 seconds. The second procedure uses a bronchoscope inserted through the nostril or mouth to visually inspect the airways and aspirate secretions intermittently to avoid hypoxia, also in 3-5 second cycles. These procedures are performed in the Emergency Department as determined by the attending physician. Participants will be monitored for various outcomes, including length of hospital stay up to three months and mortality within 30 days of Emergency Department admission. Respiratory parameters, rates of non-invasive ventilation or intubation, admission to intensive or high dependency care units, and procedure-related complications will also be recorded. The total study duration is three years, starting after ethical approval, during which clinical data and patient outcomes will be closely observed.
CONDITIONS
Brief Title
FBS-ASaP: Fibrobronchoscopy in ASpiration Pneumonia in the Emergency Department
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Diagnosed with aspiration pneumonia requiring secretion or ingesta aspiration in the Emergency Department
- Have at least one of the following: radiological evidence of pneumonia, clinical diagnosis of aspiration pneumonia, presence of secretions in upper airways, respiratory distress in a patient with swallowing difficulties, or need for oxygen therapy or increased oxygen in patients already on home oxygen
You will not qualify if you...
- Lack of consent
- Under 18 years of age
- Pregnancy
- Bleeding disorders
- Malignant cardiac arrhythmias such as ventricular tachycardia or advanced AV block (excluding first-degree AV block)
- Severe airway obstruction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day during Emergency Department visit
Participants undergo either laryngotracheal aspiration using a blind probe or aspiration using fibrobronchoscopy to remove secretions from the airways.
1 procedure visit (in-person)
Duration - Up to 3 months
Participants are observed for respiratory parameters, procedure-related complications, and outcomes including hospital stay length and mortality.
Follow-up assessments including measurements immediately and 30 minutes after the procedure, and monitoring up to 3 months
Trial Site Locations
Total: 1 location
1
AOU Careggi
Florence, Tuscany/Italy, Italy, 50122
Actively Recruiting
Research Team
L
Lorenzo Pelagatti, Dr
P
Pelagatti Lorenzo, Dr
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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