Single Use Flexible Bronchoscopes in Interventional Pulmonary Procedures

August 4, 2024 updated by: Goran Glodić, Clinical Hospital Centre Zagreb

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Zagreb, Croatia, 10000
        • University Hospital Centre Zagreb

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall performance
Time Frame: 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)
through study completion, an average of 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functionality, handle and interface
Time Frame: 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)
through study completion, an average of 12 months
Suction
Time Frame: 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)
through study completion, an average of 12 months
Image quality
Time Frame: 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)
through study completion, an average of 12 months
Bleeding control
Time Frame: 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)
through study completion, an average of 12 months
Compatibility
Time Frame: 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)
through study completion, an average of 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinical Hospital Centre Zagreb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2023

Primary Completion (Actual)

March 29, 2024

Study Completion (Actual)

March 29, 2024

Study Registration Dates

First Submitted

November 13, 2023

First Submitted That Met QC Criteria

November 20, 2023

First Posted (Actual)

November 22, 2023

Study Record Updates

Last Update Posted (Actual)

August 6, 2024

Last Update Submitted That Met QC Criteria

August 4, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8.1-22/21-2; 02/013AG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stridor

Clinical Trials on Single Use Bronchoscope

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe