RASECAL-Bronchoscopic Ambusampler

Last updated: December 5, 2024
Sponsor: Chelsea and Westminster NHS Foundation Trust
Overall Status: Completed

Phase

N/A

Condition

Lung Injury

Respiratory Failure

Treatment

N/A

Clinical Study ID

NCT05964075
RASECAL Study
  • Ages 18-100
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

(All are required)

  • Clinicians experienced in performing bronchoscopies (i.e. bronchoscopists shouldhave performed a minimum 5 bronchoscopies in mechanically ventilated patients and aminimum of 5 bronchoscopies in a simulated or practice setting).

  • Clinicians who have undergone the online product-training module for the use of theAmbu Bronchosampler, with self-certification documented.

  • Clinicians who have simulated the online product training module using an AmbuBronchosampler and Ambu Ascope4 a minimum of 5 times in a practice setting and haveself-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 beenobtained

Exclusion

Exclusion Criteria:

Investigators

  • Investigators who have not completed product training in aScope BronchoSampler byonline and hands-on from Ambu product specialists or an experienced user from thesite.

  • Investigators with experience in < 5 self-verified simulated fluid samplingprocedures 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 thepatient

Study Design

Total Participants: 207
Study Start date:
January 14, 2022
Estimated Completion Date:
October 10, 2024

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.

Connect with a study center

  • Chelsea and Westminster Hospital NHSFT

    London, SW10 0XD
    United Kingdom

    Site Not Available

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