Single Use Flexible Bronchoscopes in Interventional Pulmonary Procedures

Not Applicable

Completed

• Conditions: Atelectasis; Stridor; Hemoptysis
• Interventions: Device: Standard Bronchoscope; Device: Single Use Bronchoscope

• Registration Number: NCT06144398
• Lead Sponsor: Clinical Hospital Centre Zagreb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-13
• Study First Submitted QC: 2023-11-20
• Study First Posted: 2023-11-22
• Study Start: 2023-11-27
• Primary Completion: 2024-03-29
• Study Completion: 2024-03-29
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-04
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard Bronchoscope	Standard Bronchoscope	-
Single Use Bronchoscope	Single Use Bronchoscope	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

University Hospital Centre Zagreb; 🇭🇷 Zagreb, Croatia