FBS-ASaP: Fibrobronchoscopy in ASpiration Pneumonia in the Emergency Department
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda Ospedaliero-Universitaria Careggi
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Lack of consent
Age < 18 years
Pregnancy
Hemorrhagic diathesis
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Laryngotracheal Aspiration Procedure Using a Probe in the Emergency Department
Procedure/SurgeryFor 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 Department
Procedure/SurgeryEquipment 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Laryngotracheal Aspiration Procedure Using a Probe in the Emergency Department1 intervention
Group B: Aspiration Using Fibrobronchoscopy in the Emergency Department1 intervention
Trial outcomes
Primary outcomes
1
Length of hospital stay in days
Length of hospital stay in days
Time frame
up to 3 months2
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
Time frame
30 days from admission to the edSecondary outcomes
1
Respiratory parameters before and after the procedure
(SpO2, FiO2)before and after the procedure
Time frame
on the admission and 30 minutes after the procedure2
Rate of patient treated with Non invase ventilation and with orotracheal intubation
Oxygen therapy devices before and after the procedure
Time frame
on the admission and 30 minutes after the procedure3
Rate of admission in Intensive care unit and High dependency unit
Hospitalization setting
Time frame
immediately after the procedure4
Procedure-related complications
Procedure-related complications
Time frame
perioperatively/periprocedurallySponsors and contacts
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Source ClinicalTrials.gov