Prospective Non-interventional Evaluation of Intubation and Intensive Care Use of the New aScope™ 4 Broncho and aView
|ClinicalTrials.gov Identifier: NCT03294213|
Recruitment Status : Completed
First Posted : September 26, 2017
Last Update Posted : February 28, 2018
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.
|Condition or disease||Intervention/treatment|
|Bronchoscopy Anesthesia||Device: aScope 4 Broncho|
|Study Type :||Observational|
|Actual Enrollment :||176 participants|
|Official Title:||Prospective Non-interventional Evaluation of Intubation and Intensive Care Use of the New aScope™ 4 Broncho and aView|
|Actual Study Start Date :||September 25, 2017|
|Actual Primary Completion Date :||January 31, 2018|
|Actual Study Completion Date :||January 31, 2018|
aScope 4 Broncho
The only data to be obtained are evaluation forms directly related to the users' perception of the aScope™ 4 Broncho
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
- User perception [ Time Frame: September 2017 to January 2018 ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03294213
|Klinik für Anästhesiologie, Universitätsmedizin Mainz|
|Mainz, Rhineland-Palatinate, Germany|
|Study Chair:||Pia Nordmand, MSc||Ambu A/S|