Anesthesia, Bronchoscopy
Conditions
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
Interventions
DEVICEaScope 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
Sponsors
Ambu A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| aScope 4 Broncho The only data to be obtained are evaluation forms directly related to the users' perception of the aScope™ 4 Broncho
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 | 176 |
| Total | 176 |
Baseline characteristics
| Characteristic | — | aScope 4 Broncho |
|---|---|---|
| Age, Continuous | — years | — |
| Race and Ethnicity Not Collected | — Participants | — |
| Region of Enrollment Denmark | — | 35 participants |
| Region of Enrollment Germany | — | 60 participants |
| Region of Enrollment Sweden | — | 14 participants |
| Region of Enrollment United Kingdom | — | 67 participants |
| Sex: Female, Male Female | — | 0 Participants |
| Sex: Female, Male Male | — | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 176 |
| other Total, other adverse events | 2 / 176 |
| serious Total, serious adverse events | 0 / 176 |
Outcome results
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.
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| aScope 4 Broncho | User Preference of Scope | Prefer aScope 4 Broncho | 103 Participants |
| aScope 4 Broncho | User Preference of Scope | Prefer standard bronchoscope | 37 Participants |
| aScope 4 Broncho | User Preference of Scope | No preference on bronchoscope | 35 Participants |