Atelectasis Clinical Trial
Official title:
Single Use Versus Standard Flexible Bronchoscopes in Interventional Pulmonary Procedures: an Open Label Randomized Controlled Trial
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | November 2024 |
Est. primary completion date | November 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Croatia | University Hospital Centre Zagreb | Zagreb |
Lead Sponsor | Collaborator |
---|---|
Clinical Hospital Centre Zagreb |
Croatia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall performance | Overall performance of the bronchoscope as graded by the operator (on a scale from 1 to 10; 1 worse, 10 best performance) | through study completion, an average of 12 months | |
Secondary | Functionality, handle and interface | Functionality, handle and interface of the bronchoscope as graded by the operator (on a scale from 1 to 10; 1 worse, 10 best performance) | through study completion, an average of 12 months | |
Secondary | Suction | Suction power of the bronchoscope as graded by the operator (on a scale from 1 to 10; 1 worse, 10 best performance) | through study completion, an average of 12 months | |
Secondary | Image quality | Image quality as graded by the operator (on a scale from 1 to 10; 1 worse, 10 best performance) | through study completion, an average of 12 months | |
Secondary | Bleeding control | Bleeding control as graded by the operator (on a scale from 1 to 10; 1 worse, 10 best performance) | through study completion, an average of 12 months | |
Secondary | Compatibility | 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) | through study completion, an average of 12 months |
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