Single Use Flexible Bronchoscopes in Interventional Pulmonary Procedures

Atelectasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06144398
• Other study ID #: 8.1-22/21-2; 02/013AG
• Status: Recruiting
• Phase: N/A
• Start date: November 27, 2023
• Est. completion date: November 2024

Study information

• Verified date: December 2023
• Source: Clinical Hospital Centre Zagreb
• Contact: Sonja Badovinac, MD, PhD
• Phone: 00385(1)2385129
• Email: sonjabadovinac1[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Atelectasis
• Hemoptysis
• Pulmonary Atelectasis
• Stridor

Intervention

Device:
• Single Use Bronchoscope
The interventional procedure is performed with a single use bronchoscope.
• Standard Bronchoscope
The interventional procedure is performed with a standard bronchoscope.

Locations

Country	Name	City	State
Croatia	University Hospital Centre Zagreb	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Hospital Centre Zagreb

Country where clinical trial is conducted

Croatia, 

Outcome

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