AOU Careggi
Florence, Tuscany/Italy, 50122, Italy
Location status: Recruiting
NCT Number: NCT06511583
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Florence, Tuscany/Italy, 50122, Italy
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
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.
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.
Time frame: up to 3 months
Length of hospital stay in days
Time frame: 30 days from admission to the ed
Mortality rate within 30 days from the time of admission to the Emergency Department
Time frame: on the admission and 30 minutes after the procedure
(SpO2, FiO2)before and after the procedure
Time frame: on the admission and 30 minutes after the procedure
Oxygen therapy devices before and after the procedure
Time frame: immediately after the procedure
Hospitalization setting
Time frame: perioperatively/periprocedurally
Procedure-related complications
Contact information is provided by the study sponsor or research team.
Lorenzo Pelagatti, Dr
CONTACT
Pelagatti Lorenzo, Dr
CONTACT
Azienda Ospedaliero-Universitaria Careggi
Other
Acronym: FBS-ASaP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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