RASECAL-Bronchoscopic Ambusampler

Launched by CHELSEA AND WESTMINSTER NHS FOUNDATION TRUST · Jul 19, 2023

Keywords

ClinConnect Summary

The RASECAL-Bronchoscopic Ambusampler trial is studying a new method for collecting fluid samples from the lungs of patients who are experiencing respiratory failure and are on mechanical ventilation. This research aims to determine if the Ambu Bronchosampler, a special tool used during a procedure called bronchoscopy, can help doctors gather important information from the lungs more effectively. This trial is currently recruiting participants, and anyone over the age of 18 who has been on mechanical ventilation for more than four hours and is scheduled for a bronchoscopy might be eligible to join.

If you or a loved one is considering participation, it’s important to know that only experienced clinicians who have undergone specific training will perform the procedures. Participants will receive a thorough explanation of the trial and must give their consent, either verbally or in writing, before taking part. This trial is designed to improve how doctors can diagnose and treat patients with serious breathing issues, and your involvement could help advance medical knowledge in this area.

Gender

ALL

Eligibility criteria

• 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