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Rasecal: RASECAL-Bronchoscopic Ambusampler

Sponsor
Chelsea and Westminster NHS Foundation Trust (Other)
Overall Status
Recruiting
CT.gov ID
NCT05964075
Collaborator
(none)
216
Enrollment
1
Location
28.5
Anticipated Duration (Months)
7.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    216 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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.
    Actual Study Start Date :
    Jan 14, 2022
    Anticipated Primary Completion Date :
    Sep 30, 2023
    Anticipated Study Completion Date :
    May 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. 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?

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chelsea and Westminster Hospital NHSFT London United Kingdom SW10 0XD

    Sponsors and Collaborators

    • Chelsea and Westminster NHS Foundation Trust

    Investigators

    • Principal Investigator: Damon 0 Foster, 0, Chelsea and Westminster NHS Foundation Trust

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chelsea and Westminster NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT05964075
    Other Study ID Numbers:
    • RASECAL Study
    First Posted:
    Jul 27, 2023
    Last Update Posted:
    Jul 27, 2023
    Last Verified:
    Apr 1, 2023
    Additional relevant MeSH terms:
    Respiratory Insufficiency

    Study Results

    No Results Posted as of Jul 27, 2023