N/A
N=176
Prospective Non-interventional Evaluation of Intubation and Intensive Care Use of the New aScope™ 4 Broncho and aView
Bronchoscopy · Anesthesia
Bottom Line
View on ClinicalTrials.gov: NCT03294213 ↗Enrolled (actual)
176
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: User Preference of Scope — 103; 37; 35 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- aScope 4 Broncho (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ambu A/S
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY User Preference of Scope |
103; 37; 35 | — |
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.
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
- None
Data sourced from ClinicalTrials.gov (NCT03294213). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.