RASECAL-Bronchoscopic Ambusampler (Rasecal)

Chelsea and Westminster NHS Foundation Trust

Status: Completed

Conditions: Respiratory Failure

Study type: Observational

Funder types: Other

Identifiers

NCT05964075

RASECAL Study

Details and patient eligibility

About

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

Full 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.

Enrollment: 207 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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