RASECAL-Bronchoscopic Ambusampler

NCT05964075 | Completed

• 1 other identifier: RASECAL Study
• Study Type: observational
• Target: 207
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients requiring clinical bronchoscopy

You may qualify if:

• (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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chelsea and Westminster NHS Foundation Trust: lead

Study Sites (1)

Chelsea and Westminster Hospital NHSFT

London, SW10 0XD, United Kingdom

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Damon 0 Foster, 0

  Chelsea and Westminster NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: July 27, 2023
• Study Start: January 14, 2022
• Primary Completion: October 10, 2024
• Study Completion: October 10, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12

Locations

GB (1)