Single Use Flexible Bronchoscopes in Interventional Pulmonary Procedures

Study Overview
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Brief Summary
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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.

Official Title
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Single Use Versus Standard Flexible Bronchoscopes in Interventional Pulmonary Procedures: an Open Label Randomized Controlled Trial

Conditions
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Atelectasis, Hemoptysis, Stridor

Intervention / Treatment
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* Device: Single Use Bronchoscope
* Device: Standard Bronchoscope


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Use Bronchoscope<br> | Device: Single Use Bronchoscope<br>* The interventional procedure is performed with a single use bronchoscope.<br>|
| Active Comparator: Standard Bronchoscope<br> | Device: Standard Bronchoscope<br>* The interventional procedure is performed with a standard bronchoscope.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchoscopy, Single Use Flexible Bronchoscope, Interventional Pulmonology