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RASECAL-Bronchoscopic Ambusampler

RASECAL-Bronchoscopic Ambusampler

Non Recruiting
18 years and older
All
Phase N/A

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Overview

Prospective, multi-centre, open labelled, 1:1randomized controlled study.

Description

  1. Patients admitted to ICU with acute respiratory failure, requiring mechanical ventilation with, suspected or confirmed COVID-19.
  2. Patients admitted to ICU with acute respiratory failure due to a condition other than COVID-19, requiring mechanical ventilation.

Eligibility

Inclusion Criteria:

(All are required)

  • Clinicians experienced in performing bronchoscopies (i.e. bronchoscopists should have performed a minimum 5 bronchoscopies in mechanically ventilated patients and a minimum of 5 bronchoscopies in a simulated or practice setting).
  • Clinicians who have undergone the online product-training module for the use of the Ambu Bronchosampler, with self-certification documented.
  • Clinicians who have simulated the online product training module using an Ambu Bronchosampler and Ambu Ascope4 a minimum of 5 times in a practice setting and have self-certified.

Population

  • Patients ≥ 18 years old
  • Patients on mechanical ventilation with Acute respiratory failure for >4h
  • Patients eligible for a clinically indicated bronchoscopy with fluid sampling. Patient information has been explained and verbal or written consent has been obtained

Exclusion Criteria:

Investigators

  • Investigators who have not completed product training in aScope BronchoSampler by online and hands-on from Ambu product specialists or an experienced user from the site.
  • Investigators with experience in < 5 self-verified simulated fluid sampling procedures using the Ambu BronchoSampler 4.8.2 Population
  • Clinician concern regarding safety of bronchoscopy
  • Involved study personal not available to perform the procedure and enroll the patient

Study details
    Respiratory Failure

NCT05964075

Chelsea and Westminster NHS Foundation Trust

20 August 2025

FAQs

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