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NCT05964075 Clinical Trial

RASECAL-Bronchoscopic Ambusampler

Respiratory Failure Clinical Trial

— Rasecal  

Official title:
A Randomized Controlled Trial to Assess the Safety and Efficiency of a Self-Contained Sampling Device /Disposable Bronchoscope System Versus Usual sampLing Procedure.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05964075
Other study ID # RASECAL Study
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 14, 2022
Est. completion date May 31, 2024

Study information
Verified date February 2024
Source Chelsea and Westminster NHS Foundation Trust
Contact Arnold Xhikola
Phone 203356825
Email arnold.xhikola1@nhs.net
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 216
Est. completion date May 31, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 100 Years
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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom Chelsea and Westminster Hospital NHSFT London

Sponsors (1)
Lead Sponsor Collaborator
Chelsea and Westminster NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Comparison of two sampling pots 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? 1month
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