RASECAL-Bronchoscopic Ambusampler

A Randomized Controlled Trial to Assess the Safety and Efficiency of a Self-Contained Sampling Device /disposable Bronchoscope System Versus Usual SampLing Procedure.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05964075

Acronym

Rasecal

Enrollment

207

Registered

2023-07-27

Start date

2022-01-14

Completion date

2024-10-10

Last updated

2024-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Failure

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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?

Countries

United Kingdom

Outcome results