Single Use Flexible Bronchoscopes in Interventional Pulmonary Procedures

NCT ID: NCT06144398

Last Updated: 2024-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-27

Study Completion Date

2024-03-29

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.

Detailed Description

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Conditions

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Atelectasis Hemoptysis Stridor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Use Bronchoscope

Group Type EXPERIMENTAL

Single Use Bronchoscope

Intervention Type DEVICE

The interventional procedure is performed with a single use bronchoscope.

Standard Bronchoscope

Group Type ACTIVE_COMPARATOR

Standard Bronchoscope

Intervention Type DEVICE

The interventional procedure is performed with a standard bronchoscope.

Interventions

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Single Use Bronchoscope

The interventional procedure is performed with a single use bronchoscope.

Intervention Type DEVICE

Standard Bronchoscope

The interventional procedure is performed with a standard bronchoscope.

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinical Hospital Centre Zagreb

OTHER

Sponsor Role lead

Responsible Party

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Goran Glodić

MD, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Centre Zagreb

Zagreb, , Croatia

Site Status

Countries

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Croatia

Other Identifiers

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

Identifier Type: -

Identifier Source: org_study_id

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