RASECAL-Bronchoscopic Ambusampler

NCT ID: NCT05964075

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

207 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-14

Study Completion Date

2024-10-10

Brief Summary

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

Detailed Description

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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.

Conditions

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Respiratory Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chelsea and Westminster NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Damon 0 Foster, 0

Role: PRINCIPAL_INVESTIGATOR

Chelsea and Westminster NHS Foundation Trust

Locations

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Chelsea and Westminster Hospital NHSFT

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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RASECAL Study

Identifier Type: -

Identifier Source: org_study_id