Single Use Flexible Bronchoscopes in Interventional Pulmonary Procedures

Clinical Hospital Centre Zagreb

Status: Completed

Conditions: Stridor; Atelectasis; Hemoptysis

Treatments: Device: Single Use Bronchoscope; Device: Standard Bronchoscope

Study type: Interventional

Funder types: Other

Identifiers

NCT06144398

8.1-22/21-2 02/013AG;

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Single Use Bronchoscope

Experimental group

Treatment:

Device: Single Use Bronchoscope

Standard Bronchoscope

Active Comparator group

Treatment:

Device: Standard Bronchoscope