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

NCT ID: NCT06511583

Last Updated: 2024-07-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-05
• Study Completion Date: 2027-03-05

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Laryngotracheal Aspiration Procedure Using a Probe in the Emergency Department

Intervention Type: 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.

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.

Aspiration Procedure Using Fibrobronchoscopy in the Emergency Department

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero-Universitaria Careggi

OTHER

Sponsor Role: lead

Responsible Party

Peiman Nazerian

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lorenzo Pelagatti, dr

Role: PRINCIPAL_INVESTIGATOR

University of Florence

Locations

AOU Careggi

Florence, Tuscany/Italy, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Lorenzo Pelagatti, Dr

Role: CONTACT

pelagattil@aou-careggi.toscana.it

+393385917317

Pelagatti Lorenzo, Dr

Role: CONTACT

lorenzo.pelagatti@unifi.it

+390557947088

Facility Contacts

Pelagatti Lorenzo, Dr

Role: primary

pelagattil@aou-careggi.toscana.it

+393385917317 ext. 00393385917317

Other Identifiers

CEAVC 22814

Identifier Type: -

Identifier Source: org_study_id