Prospective Non-interventional Evaluation of Intubation and Intensive Care Use of the New aScope™ 4 Broncho and aView

Ambu

Status: Completed

Conditions: Bronchoscopy; Anesthesia

Treatments: Device: aScope 4 Broncho

Study type: Observational

Funder types: Industry

Identifiers

NCT03294213

CIS-002

Details and patient eligibility

About

This study is designed as a prospective observational, non-controlled, non-interventional study.

The aim of this study is to obtain a broad user perspective of the aScope™ 4 Broncho, focusing on the device functionalities within regular clinical practice and therapeutic use of flexible bronchoscopes in the OR and ICU.

The study will include a minimum of 100 adult patients admitted to the operating room (OR) or Intensive Care Unit (ICU) undergoing at least one bronchoscopy procedure. The inclusion will stop when 100 fully evaluable patients or a maximum of 150 patients have been enrolled.

The involved sites will include patients during a five months' period, from September 2017 to January 2018.

Full description

Refer to brief description

Enrollment: 176 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient's ≥18 years
• Clinical indication and eligible for an airway procedure involving a bronchoscopy procedure, as judged by the Investigator
• Patients being admitted in the OR or ICU at the investigational site

Exclusion criteria

• None

Trial design

176 participants in 1 patient group

aScope 4 Broncho

Description:

The only data to be obtained are evaluation forms directly related to the users' perception of the aScope™ 4 Broncho

Treatment:

Device: aScope 4 Broncho