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

NCT06511583 | Recruiting

• 1 other identifier: CEAVC 22814
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Aspiration pneumonia; Bronchoscopy; toilette; interventional pulmunology; respiratory failure; pneumonia; bacterial pneumonia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Respiratory parameters 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

  on the admission and 30 minutes after the procedure

• Rate of admission in Intensive care unit and High dependency unit

  immediately after the procedure

• Procedure-related complications

  perioperatively/periprocedurally

Study Arms (2)

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

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

Interventions

Laryngotracheal Aspiration Procedure Using a Probe in the Emergency Department PROCEDURE

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.

Laryngotracheal Aspiration Procedure Using a Probe in the Emergency Department

Aspiration Procedure Using Fibrobronchoscopy in the Emergency Department PROCEDURE

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.

Aspiration Using Fibrobronchoscopy in the Emergency Department

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Careggi: lead

Study Sites (1)

AOU Careggi

Florence, Tuscany/Italy, 50122, Italy

RECRUITING

MeSH Terms

Conditions

Pneumonia, Aspiration; Respiratory Insufficiency; Pneumonia; Pneumonia, Bacterial

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Lorenzo Pelagatti, dr

  University of Florence

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorenzo Pelagatti, Dr

CONTACT

+393385917317; pelagattil@aou-careggi.toscana.it

Pelagatti Lorenzo, Dr

CONTACT

+390557947088; lorenzo.pelagatti@unifi.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 22, 2024
• Study Start: February 5, 2024
• Primary Completion (Estimated): February 5, 2027
• Study Completion (Estimated): March 5, 2027
• Last Updated: July 22, 2024

Record last verified: 2024-07

Locations

IT (1)