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NCT Number: NCT06511583

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AOU Careggi

Florence, Tuscany/Italy, 50122, Italy

Location status: Recruiting

Location contact

Pelagatti Lorenzo, Dr

CONTACT

[email protected]

+393385917317 ext. 00393385917317

Who can participate

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

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Length of hospital stay in days

    Time frame: up to 3 months

    Length of hospital stay in days

  2. Mortality rate within 30 days from the time of admission to the Emergency Department

    Time frame: 30 days from admission to the ed

    Mortality rate within 30 days from the time of admission to the Emergency Department

Secondary outcomes

  1. Respiratory parameters before and after the procedure

    Time frame: on the admission and 30 minutes after the procedure

    (SpO2, FiO2)before and after the procedure

  2. Rate of patient treated with Non invase ventilation and with orotracheal intubation

    Time frame: on the admission and 30 minutes after the procedure

    Oxygen therapy devices before and after the procedure

  3. Rate of admission in Intensive care unit and High dependency unit

    Time frame: immediately after the procedure

    Hospitalization setting

  4. Procedure-related complications

    Time frame: perioperatively/periprocedurally

    Procedure-related complications

Study contacts

Contact information is provided by the study sponsor or research team.

Lorenzo Pelagatti, Dr

CONTACT

[email protected]

+393385917317

Pelagatti Lorenzo, Dr

CONTACT

[email protected]

+390557947088

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria Careggi

Other

Registry information

Acronym: FBS-ASaP

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 22, 2024
Registry last updated
Jul 22, 2024

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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