Prospective Non-interventional Evaluation of Intubation and Intensive Care Use of the New aScope™ 4 Broncho and aView
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bronchoscopy
- Sponsor
- Ambu A/S
- Enrollment
- 176
- Locations
- 1
- Primary Endpoint
- User Preference of Scope
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
Refer to brief description
Investigators
Eligibility Criteria
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
- Not provided
Outcomes
Primary Outcomes
User Preference of Scope
Time Frame: Data on patients from September 2017 to January 2018, investigators memory assessed immediately following use of the aSCope 4TM Broncho at each patient visit
This non-interventional study compared the clinical performance of the Ambu aScope 4TM Bron-cho with the standard bronchoscope (reusable or single-use) normally used at each of the study centers based on the investigators memory of the standard bronchoscope.