Evaluation of BAL Procedure With Ambu aScope 3 Large in Patients in an ICU Setting

Ambu

Status: Terminated

Conditions: Atelectasis; Bronchoscopy

Treatments: Device: Bronchoscopic procedure

Study type: Interventional

Funder types: Industry

Identifiers

NCT03581474

CIS-001

Details and patient eligibility

About

An Investigation to determine the single-use scope's ability to suction secretion from the lungs to resolve the collapse of the lung.

Full description

The purpose of this investigation it to determine the single-use scope's ability to suction secretion from the lungs to resolve the collapse of the lung. The hypothesis is that aScope 3 Large is able to manage the secretion and thereby facilitating the resolution of secretion in the lung.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients ≥18 years
• Clinical indication and eligible for a BAL procedure, as judged by the investigator
• Patients being admitted in the ICU at the investigational centre
• Provision of signed IC by subject, or subject's legal representative e.g. next of kin

Exclusion criteria

• Patients where BAL treatment cannot be clinically justified, judged by the investigator
• ETT >7 mm and ≤8.5 mm in diameter
• Participating in other interventional clinical investigations or have previously participated in this investigation

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

aScope 3 Large

Other group

Description:

Bronchoscopic procedure

Treatment:

Device: Bronchoscopic procedure