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

A

Azienda Ospedaliero-Universitaria Careggi

Status

Enrolling

Conditions

Bronchoscopy
Aspiration Pneumonia

Treatments

Procedure: Aspiration Procedure Using Fibrobronchoscopy in the Emergency Department
Procedure: Laryngotracheal Aspiration Procedure Using a Probe in the Emergency Department

Study type

Observational

Funder types

Other

Identifiers

NCT06511583
CEAVC 22814

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Laryngotracheal Aspiration Procedure Using a Probe in the Emergency Department
Description:
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.
Treatment:
Procedure: Laryngotracheal Aspiration Procedure Using a Probe in the Emergency Department
Aspiration Using Fibrobronchoscopy in the Emergency Department
Description:
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.
Treatment:
Procedure: Aspiration Procedure Using Fibrobronchoscopy in the Emergency Department

Trial contacts and locations

1

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Central trial contact

Lorenzo Pelagatti, Dr; Pelagatti Lorenzo, Dr

Data sourced from clinicaltrials.gov

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