RASECAL-Bronchoscopic Ambusampler

Completed

• Conditions: Respiratory Failure

• Registration Number: NCT05964075
• Lead Sponsor: Chelsea and Westminster NHS Foundation Trust

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 condition other than COVID-19, requiring mechanical ventilation.

Study Timeline

• Study Start: 2022-01-14
• Study First Submitted: 2023-04-18
• Study First Submitted QC: 2023-07-19
• Study First Posted: 2023-07-27
• Primary Completion: 2024-10-10
• Study Completion: 2024-10-10
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of two sampling pots	1month	Can the Ambu Bronchosampler improve safety versus usual standard care by reducing the risk of spillage or disconnection of the sampling system during a procedure?

Trial Locations

Locations (1)

Chelsea and Westminster Hospital NHSFT; 🇬🇧 London, United Kingdom