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OpenTrials
Completed

NCT Number: NCT05964075

RASECAL-Bronchoscopic Ambusampler

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

Completed

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chelsea and Westminster Hospital NHSFT

London, SW10 0XD, United Kingdom

About this study

  • Patients admitted to ICU with acute respiratory failure, requiring mechanical ventilation with, suspected or confirmed COVID-19.
  • Patients admitted to ICU with acute respiratory failure due to a condition other than COVID-19, requiring mechanical ventilation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Comparison of two sampling pots

    Time frame: 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?

Sponsors and collaborators

Lead sponsor

Chelsea and Westminster NHS Foundation Trust

Other

Registry information

Official study title

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

Acronym: Rasecal

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 27, 2023
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.