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OpenTrials
Completed

NCT Number: NCT03294213

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

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.

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Key information

Conditions

Bronchoscopy Anesthesia

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinik für Anästhesiologie, Universitätsmedizin Mainz

Mainz, Rhineland-Palatinate, Germany

About this study

Refer to brief description

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aScope 4 Broncho

Device

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Ambu A/S

Industry

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 26, 2017
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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