FBS-ASaP: Fibrobronchoscopy in ASpiration Pneumonia in the Emergency Department (FBS-ASaP)

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 Overview

• Status: Recruiting
• Conditions: Aspiration Pneumonia; Bronchoscopy
• Intervention / Treatment: Procedure: Laryngotracheal Aspiration Procedure Using a Probe in the Emergency Department; Procedure: Aspiration Procedure Using Fibrobronchoscopy in the Emergency Department

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Pelagatti Lorenzo, Dr; Phone Number: +390557947088; Email: lorenzo.pelagatti@unifi.it
• Study Contact Backup: Name: Lorenzo Pelagatti, Dr; Phone Number: +393385917317; Email: pelagattil@aou-careggi.toscana.it

Study Locations

• Italy
  • Tuscany/Italy
    • Florence, Tuscany/Italy, Italy, 50122
      • Recruiting
      • AOU Careggi
      • Contact: Pelagatti Lorenzo, Dr; Phone Number: 00393385917317 +393385917317; Email: pelagattil@aou-careggi.toscana.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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

• 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

Exclusion Criteria:

• Lack of consent
• Age < 18 years
• Pregnancy
• Hemorrhagic diathesis
• Malignant cardiac arrhythmias (VT, AV block excluding first-degree AV block)
• Severe airway obstruction

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: Laryngotracheal Aspiration Procedure Using a Probe in the Emergency Department; 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; 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.	Procedure: Aspiration Procedure Using Fibrobronchoscopy in the Emergency Department; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero-Universitaria Careggi
• Investigators: Principal Investigator: Lorenzo Pelagatti, dr, University of Florence

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2024
• Primary Completion (Estimated): February 5, 2027
• Study Completion (Estimated): March 5, 2027

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): July 22, 2024
• Last Update Submitted That Met QC Criteria: July 15, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Bronchoscopy; pneumonia; respiratory failure; Aspiration pneumonia; bacterial pneumonia; toilette; interventional pulmunology
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Pneumonia, Aspiration
• Other Study ID Numbers: CEAVC 22814

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No