Atelectasis, Hemoptysis, Stridor
Conditions
Keywords
Bronchoscopy, Single Use Flexible Bronchoscope, Interventional Pulmonology
Brief summary
Single Use Flexible bronchoscopes have gained popularity in recent years and are becoming technologically more advanced. They are widely accepted and used in everyday practice for simple procedures. The aim of this study is to evaluate single use flexible bronchoscopes in more advanced settings, such as interventional pulmonary procedures.
Interventions
DEVICESingle Use Bronchoscope
The interventional procedure is performed with a single use bronchoscope.
DEVICEStandard Bronchoscope
The interventional procedure is performed with a standard bronchoscope.
Sponsors
Clinical Hospital Centre Zagreb
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* All patients requiring an interventional pulmonary procedure during the study period * Signed informed consent
Exclusion criteria
* Any patient with a contraindication for rigid and/or flexible bronchoscopy * Coagulopathy (PV INR \> 1.3) * Thrombocytopenia (\<50x10\*9 or anemia (Hgb \<80 g/L) * DOAC, LMWH or antiplatelet drug therapy * Thrombophilia, history of pulmonary embolism or deep vein thrombosis * Contraindication for endobronchial application of adrenaline * Uncontrolled coronary artery disease, cerebrovascular disease or arrhythmia * Uncontrolled pulmonary hypertension * Cardiovascular decompensation * Severe hypoxia (PaO2 \<60mmHg, SaO2 \<90% with an FiO2 \>=60%) * Cervical spine instability
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall performance | through study completion, an average of 12 months | Overall performance of the bronchoscope as graded by the operator (on a scale from 1 to 10; 1 worse, 10 best performance) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functionality, handle and interface | through study completion, an average of 12 months | Functionality, handle and interface of the bronchoscope as graded by the operator (on a scale from 1 to 10; 1 worse, 10 best performance) |
| Suction | through study completion, an average of 12 months | Suction power of the bronchoscope as graded by the operator (on a scale from 1 to 10; 1 worse, 10 best performance) |
| Image quality | through study completion, an average of 12 months | Image quality as graded by the operator (on a scale from 1 to 10; 1 worse, 10 best performance) |
| Bleeding control | through study completion, an average of 12 months | Bleeding control as graded by the operator (on a scale from 1 to 10; 1 worse, 10 best performance) |
| Compatibility | through study completion, an average of 12 months | Compatibility with other devices (i.e. ballon blockers, forceps, laser, cryprobe) as graded by the operator (on a scale from 1 to 10; 1 worse, 10 best performance) |
Countries
Croatia
Outcome results
None listed