Status:
COMPLETED
RASECAL-Bronchoscopic Ambusampler
Lead Sponsor:
Chelsea and Westminster NHS Foundation Trust
Conditions:
Respiratory Failure
Eligibility:
All Genders
18-100 years
Brief Summary
Prospective, multi-centre, open labelled, 1:1randomized controlled study.
Detailed 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 ...
Eligibility Criteria
Inclusion
- (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
- 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
Key Trial Info
Start Date :
January 14 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 10 2024
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT05964075
Start Date
January 14 2022
End Date
October 10 2024
Last Update
December 10 2024
Active Locations (1)
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1
Chelsea and Westminster Hospital NHSFT
London, United Kingdom, SW10 0XD