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

Completed

• Conditions: Anesthesia; Bronchoscopy
• Interventions: Device: aScope 4 Broncho

• Registration Number: NCT03294213
• Lead Sponsor: Ambu A/S

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

Study Timeline

• Study First Submitted: 2017-09-22
• Study First Submitted QC: 2017-09-22
• Study Start: 2017-09-25
• Study First Posted: 2017-09-26
• Primary Completion: 2018-01-31
• Study Completion: 2018-01-31
• Results First Submitted: 2020-05-26
• Status Verified: 2021-02
• Results First Submitted QC: 2021-02-11
• Last Update Submitted: 2021-02-11
• Results First Posted: 2021-03-03
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
User Preference of Scope	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.

Trial Locations

Locations (1)

Klinik für Anästhesiologie, Universitätsmedizin Mainz; 🇩🇪 Mainz, Rhineland-Palatinate, Germany