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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03294213
• Other study ID #: CIS-002
• Status: Completed
• Start date: September 25, 2017
• Est. completion date: January 31, 2018

Study information

• Verified date: February 2021
• Source: Ambu A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Refer to brief description

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: January 31, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Bronchoscopy

Intervention

Device:
• aScope 4 Broncho
Investigator is asked: "In your memory, compare your daily bronchoscope and the aScope 4 Broncho just evaluated" on patients admitted to the OR or ICU undergoing at least one bronchoscopy procedure Patients will not be asked to consent to participate in this study, as no patient data are obtained and the CE-marked aScope™ 4 Broncho is used within its intended use

Locations

Country	Name	City	State
Germany	Klinik für Anästhesiologie, Universitätsmedizin Mainz	Mainz	Rhineland-Palatinate

Sponsors (1)

Lead Sponsor	Collaborator
Ambu A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	User Preference of Scope	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.	Data on patients from September 2017 to January 2018, investigators memory assessed immediately following use of the aSCope 4TM Broncho at each patient visit

External Links

•   Publication of study results